Search Jobs
If you are ready to propel your career to new heights… read on. We are looking for talented and dedicated colleagues to join our phenomenal team and work on consulting engagements with our FORTUNE 500 clients.
At The Ascent Services Group, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and the idea is implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.
Come join the best and brightest in the industry.
Is this you?
- You are tireless, fearless and selfless
- You are passionate about your job responsibilities
- You like a challenge
- You may not even actively be looking, but you'd like a midsize company that feels like you.
- You do not like to waste time and you are fast at everything you do
The Perks for Working @ The Ascent Services Group
We strive to be innovative and unique in all services including employee compensation, benefits and perks offerings. Since our employees are the foundation of our success we offer some of the best compensation packages in the industry that include; salary, medical, dental, vision, 401k, vacation, telecommuting, employee assistant programs, life insurance, short and long term disability. In a nutshell, our employees are awarded lucratively for their contributions, commitments, and achievements to the firm.
Current Openings
IT Positions
- Senior Business Analyst
- Senior Project Managers/Program Managers (PMP, RUP, UML)
- Senior Desktop Support Analyst
- Senior Network Architect
- Senior Java Developers
- Senior QA Analyst
- Data Warehouse Architect
- Technical Writer
- SAS Developers
- Senior User Interface Developer
- Senior .NET Developer
- Project Coordinator
- Data Analyst
Clinical Positions
- Clinical Program Manager
- SAS Applications Manager (IT Lead Analyst)
- Program Director-Drug Regulatory Affairs CMC
- Global Clinical Study Manager
- Statistical Leader
- Medical Director-Rheumatology
- Medical Science Liaison
- Associate/Director - Regulatory Affairs
- Associate Clinical Director - Oncology
- Sr. Clinical Compliance Specialist
- Manager/Senior Manager, Drug Safety
- Clinical Data Manager
- Brand Safety Leader
- Senior Clinical Regulatory Affairs Associate
- Quality Assurance Auditor - GCP
- Drug Safety Medical Writer II
Senior Business Analyst
(5 Openings, Base 90-110k)
Job Description / Responsibilities
The ideal candidate will have strong group facilitation skills, be very organized and have excellent verbal and written communication skills. Also, they will have worked at a mid-to-large company on large enterprise level projects that cross business processes. To qualify you must have at least five years experience in a Business Analyst role where you interfaced directly with business leaders to elicit, verify and document business requirements. You must have experience in Use Case methodology and be able to provide representative examples to get an interview. This contract opportunity has a high probably of being extended and the potential to be converted into a permanent position.
Qualifications / Experience
- Business Analyst - at least 5 years
- Requirements Elicitation, Development, Verification & Documentation
- Use Case Methodology
- Business/Technology Translator
- Enterprise Project Experience
- Project Coordination
- Effective and Confident Communicator - Verbal & Written
- Strong Group Facilitation
- Healthcare a plus
- Use Case Modeling
- Facilitator
- Communication Skills
- MS Office
- Preferred skills include: Project Coordinator, Bachelor's Degree, Healthcare
Location
Walnut Creek, San Jose, SF, Redwood City
Position Type
Contract, Contract to Hire, and Direct Hire
To apply for this position, email your résumé to Jim Jhanda.
Senior Project Managers/Program Managers (PMP, RUP, UML)
(4 Openings, Base 125k-175k)
Job Description / Responsibilities
We are looking for a senior-level project managers or program managers to manage two, possibly more, mission critical projects.
The project manager will be accountable to the Enterprise Project Management Office (EPMO), but will be working directly with the business owners, and will apply their experience, skills, tools and techniques to project activities to organize, lead, negotiate, and speak on behalf of the project. They will be responsible for managing the day-to-day project activities while utilizing the knowledge of subject matter experts, manage both vendor and internal resources, and keep the teams focus on the intended objectives to deliver the project. Must be able to set priorities, develop a work schedule, monitor and report project / deliverables progress, assess situations to determine the importance, urgency and risks, and make clear decisions which will be timely and in the best interests of the organization.
Qualifications / Experience
- Have 6+ years hands-on experience in managing large projects
- Strong scope identification and change control capabilities
- Working knowledge of IT functions / services
- Proficient in MS Project, MS SharePoint, and the entire MS Office Suite
- Possess strong communication and interpersonal skills
- PMP certification
- Healthcare Care Management experience a plus
Location
Walnut Creek, San Jose, SF, Redwood City
Position Type
Contract, Contract to Hire, and Direct Hire
To apply for this position, email your résumé to Jim Jhanda.
Senior Desktop Support Analyst
(10 Openings, Salary 45-60k)
Job Description / Responsibilities
- Responsible day to day support of PC hardware and software
- Responsible for resolving daily tickets and prioritizing daily activities
- Provide primary technical support and understands when to escalate issues for resolution
- Install, configure and relocate computer hardware and software as required
- Take ownership of client issues and escalate issues to third parties or vendors as appropriate
- Follow documented processes to resolve common issues
- Create, document, and update processes to resolve common issues
- Work with end users to ensure that only authorized hardware and software is used on corporate computer equipment
- Maintain documentation and inventory information
- Basic user training/education
- Assist users in solving more complex business problems with various technologies
Qualifications / Experience
- 2-5 years of desktop support experience
- Experience with Help Desk software and working with Service Level Agreements
- Excellent analytical and problem-solving skills
- Bright, energetic, hard-working candidate
- Advanced Windows XP system configuration and troubleshooting skills
- Experience supporting a managed Windows PC environment including expert knowledge of MS Outlook and Office applications (XP, 2003, 2007)
- Proficiency in the imaging and deployment of PC*s in a corporate environment; working knowledge of Symantec Ghost.
- PC hardware and printer support experience
- Knowledge of networking principles, practices and technologies (TCP/IP protocol suite).
- LAN/WAN troubleshooting and administration skills;
- Excellent written and verbal communication skills
- Ability to maintain effective working relationships with supervisor and coworkers
- Outstanding communication skills, enthusiasm, and ability to handle multiple tasks and prioritize support and project support requirements
- Candidate must be someone who takes initiative and can manage day to day tasks with a minimum of supervision
Location
Concord, San Jose, San Mateo, San Francisco
Position Type
Contract, Contract to Hire, and Direct Hire
To apply for this position, email your résumé to Jim Jhanda.
Senior Network Architect
(3 Openings, Salary 110-130k)
Job Description / Responsibilities
The Network Architect is intended to investigate scope and initiate new applications/architectures within the organization and get them introduced to the business with the full backing and understanding of all sub-groups and the business owners impacted. It is also intended to highlight potential synergies and opportunities for leveraging applications and developments through the group to develop business opportunities at a manageable cost. A specific responsibility will be assisting diverse business units in developing their technology for specific needs whilst keeping within company standards and employing economies of scale. New customers/potential customers solutions and integration will be scoped by this position before being formally handed to other areas for implementation.
- Be familiar with the business as a whole and its systems, practices and procedures; use knowledge of existing eco-system and operations matrix to deliver cost effective designs for new/improved services
- Keep up to date with new technology to enable the business to respond to change with up to date technology briefing; contribute technical piece to all major tenders and/or business developments
- Design and smoke out new customer business requirements. Work with sales teams to deliver real, realistic and achievable architecture plans; support external sales opportunities and represent its diverse strengths to customers and potential customers
- Establish processes to foster clear, concise, complete, accurate and timely communication up/across/down the organization; develop a highly collaborative environment where anyone (from all levels/departments) can present ideas.
- Encourage and develop communication between business units; build strong relationships with third-party vendors.
Qualifications / Experience
- 10 years experience managing world class networks
- Excellent oral and written communication skills
- Able to work with and through people on a cross-cultural basis
- Able to set and manage multiple priorities
- Must have a can-do manner and good problem-solving skills
- Ability to see the "big picture"; creative thinker; excellent organizing and negotiating skills
- Experience with telecommunications product development and telecommunications carriers
- Must have knowledge of VoIP, SIP and TDM networks
- Must have knowledge of call center services and familiarity with server design and web technologies
Location
Bay Area
Position Type
Contract, Contract to Hire, and Direct Hire
To apply for this position, email your résumé to Jim Jhanda.
Senior Java Developers
(5 Openings, Salary 95-110k)
Job Description / Responsibilities
Looking for a senior level java developers to supplement their current staff on multiple projects that are fully developed. We are looking for candidates that are able to work through business requirements that are vague and not as well defined. Candidates must be able to work independently and be able to provide solutions to business problems for different business units. Ideal candidates will have the ability to write SQL queries directly to the oracle database and have worked with data access frameworks.
Write Java data and business services for e-Commerce projects. Develop reusable Web Services to efficiently work in a Service Oriented Architecture. Experience designing, developing, debugging and deploying java web services using open industry standards such as SOAP, WSDL, and REST. Integrate services with databases, applications, and messaging infrastructure. Work closely with team members, communicate effectively, and the ability to turn business requirements into design and code.
Qualifications / Experience
- 5+ years Senior Java Developer.
- J2EE , JSP , Servlets , JSTL , etc.
- Strong Web Services application development , mainly in Java , preferably Axis and Xmlbeans
- Experience and working knowledge of Struts and/or Spring frameworks
- Experience with the full Software Development Life Cycle.
- Experience with web applications that handle high-volume.
- Excellent Communication Skills.
Nice to Have:
- Solid working knowledge of WebLogic , WebSphere , or similar Application Servers.
- Able to interface across multiple lines of business and technology groups.
- Good organization and follow-up skills.
- Strong experience with HTML , Javascript , CSS.
- Setting up and implementing JUnit (or other) testing framework.
- Strong knowledge of how to monitor applications to ensure 24x7 uptime.
- Good working knowledge of Fail Over and Redundancy and how to ensure these are handled.
- Experience with SQL and JDBC.
- Experience in the banking or financial industry.
Location
San Francisco, San Jose
Position Type
Contract, Contract to Hire, and Direct Hire
To apply for this position, email your résumé to Jim Jhanda.
Senior QA Analyst
Job Description / Responsibilities
The purpose of this job is to assist in the development and implementation of quality test strategies and methods in compliance with overall QA Methodology for the customers IT solutions. This job is responsible for analyzing, testing, tracking and issue reporting of IT product lines that are developed for customers. This position works in collaboration with Application Development, the Quality Assurance team, Project Management, Business Analysts, and other IT stakeholders to ensure that the applications development projects have been tested thoroughly and meet the required deliverables and quality standards. Role includes planning, designing, executing and tracking the results of associated test efforts.
Responsibilities include:
- Participate in design reviews and analyze documentation
- Develop, review, and execute test plans to ensure a 98% accuracy rating
- Develop work plans, monitor a project work plan, provide status, and report problems to management in a timely manner
- Lead software testing projects
- Assist with training of other team members
- Assure customer satisfaction
- Organize, participate, and conduct test plans walk-throughs of peers and subordinates
- Work with Technical Analysts, Business Analysts and the user community in problem solving and requirements definition
- Build and maintain relationship with customers, both internal and external
- Develop user-oriented training materials and programs
- Conduct user training
- Develop and communicate project/task estimates and project plans
Qualifications / Experience
- 5+ years IT experience as a tester.
- Good understanding of process flow.
- Ability to work to tight deadlines.
- Ability to work with minimal supervision.
- Strong verbal and written communication skills.
- Local candidates preferred.
Specific Industry/Tools:
- RUP tools
- ClearCase
- ClearQuest
- Rational Rose
- Requisite Pro
- Mercury tools
- WinRunner
- LoadRunner
- QA Run
- Test Director
Location
San Jose, CA; Walnut Creek, CA;, San Francisco, CA;, Redwood City, CA;, Denver, CO; Pasadena, CA; Corona, CA; Minneapolis, MN; Portland, OR; Seattle, WA; Silver Spring, MD; Plano, TX; Houston, TX; New York, NY; Chicago, IL; Austin, TX
Position Type
Contract, Contract to Hire, and Direct Hire
To apply for this position, email your résumé to Jim Jhanda.
Data Warehouse Architect
Job Description / Responsibilities
You will work cross-functionally to define and prioritize business and data requirements. You will develop the overall data warehouse architecture including the design of ETL process. You will be responsible for ensuring proper functioning of the data warehouse through testing and quality control procedures.
Additional responsibilities will include performing basic Oracle DBA functions, developing access and delivery methods, defining data warehouse standards (metadata) and ensuring data warehouse security. You will also be responsible for system monitoring and performance optimization.
Qualifications / Experience
- Understands/Experienced in the full data warehouse life cycle
- Familiar with Best Practices across all project phases (architecture, ETL Development, Business Intelligence Development)
- Responsible for coordinating the overall technical solution, including detail design; resolving technical issues during development
- Expert in Informatica/Business Objects technologies/solutions
- Dimensional modeling experience
- Manages and communicates technical/functional design to developers
- Ability to establish solid working relationships with peers and staff
- Ability to create and deliver results in a highly collaborative environment
Location
San Jose, CA; Walnut Creek, CA;, San Francisco, CA;, Redwood City, CA;, Denver, CO; Pasadena, CA; Corona, CA; Minneapolis, MN; Portland, OR; Seattle, WA; Silver Spring, MD; Plano, TX; Houston, TX; New York, NY; Chicago, IL; Austin, TX
Position Type
Contract, Contract to Hire, and Direct Hire
To apply for this position, email your résumé to Jim Jhanda.
Technical Writer
Job Description / Responsibilities
As a member of the technical writing division, you will organize and prepare information for publication and develop publication concepts for the best communication of subject matter. Review technical information prepared by other staff members for clarity and content. Take an active role in the definition and evolution of standard practices and procedures.
Qualifications / Experience
- BS or MS degree and seven years of related work experience.
- Excellent writing and editing skills, typography and the principles of graphic design and layout. Indexing skills a plus.
- Experience with standard documentation authoring tools (FrameMaker: structured, Adobe Acrobat, and graphics software).
- Experience writing software guides and help systems, etc., in a single-source format (creating PDF and HTML output).
- Experience with working with development prototypes for enterprise-wide systems is highly desired.
- Experience and excitement for content management.
- Familiarity with web servers, Windows system configuration, and/or UNIX is a plus.
- Entrepreneurial attitude, technical aptitude, persistency, and attention to detail highly preferred.
Location
San Jose, CA; Walnut Creek, CA;, San Francisco, CA;, Redwood City, CA;, Denver, CO; Pasadena, CA; Corona, CA; Minneapolis, MN; Portland, OR; Seattle, WA; Silver Spring, MD; Plano, TX; Houston, TX; New York, NY; Chicago, IL; Austin, TX
Position Type
Contract, Contract to Hire, and Direct Hire
To apply for this position, email your résumé to Jim Jhanda.
SAS Developers
Job Description / Responsibilities
We are seeking a highly motivated SAS developer with 10+ years experience in SAS programming to work in exciting startup environment with a small team. This opportunity is on a 6 month contract to hire basis. Developing SAS applications withusing Base SAS, SAS Graph and, SAS Stat usingan SAS Enterprise Guide. Developing and refining SAS reports and dashboards using the Web Report Studio. Assisting in development of OLAP cubes using SAS OLAP tools within the Enterprise BI suite. Administrator for the SAS environment. SAS Certification a strong plus.
Qualifications / Experience
- SAS Programming Required 10 Years 5- Expert Knowledge
- Base SAS Required 3 Years 4- In-Depth Knowledge
- SAS Graph Required 3 Years 4- In-Depth Knowledge
- MacroACROs Language Required 4- In-Depth Knowledge
- Programming exp for finance or insurance industries Required 10 Years 5- Expert Knowledge
- Oracle or MS SQL Required 3 Years 4- In-Depth Knowledge
- Predictive Modeling Required 4- In-Depth Knowledge
- Multi-variate data analysis Required 4- In-Depth Knowledge
- Text Mining Highly desired 3- Working Knowledge
- Analytical & problem solving skills Required 5- Expert Knowledge
- Organizational skills Required 5- Expert Knowledge
- Self-motivated Required 5- Expert Knowledge
- Verbal Communication Required 5- Expert Knowledge
- Written Communication Required 5- Expert Knowledge
- Manage tasks on multiple-projects Required 5- Expert Knowledge
Location
San Jose, CA; Walnut Creek, CA;, San Francisco, CA;, Redwood City, CA;, Denver, CO; Pasadena, CA; Corona, CA; Minneapolis, MN; Portland, OR; Seattle, WA; Silver Spring, MD; Plano, TX; Houston, TX; New York, NY; Chicago, IL; Austin, TX
Position Type
Contract, Contract to Hire, and Direct Hire
To apply for this position, email your résumé to Jim Jhanda.
Senior User Interface Developer
Job Description / Responsibilities
In this key development role, you will work closely with staff in the Software Development, Project Management, and Quality Assurance groups to build large, high profile websites and web applications. Reporting to the UI Development Manager, you will be responsible for the efficient and faithful translation of visual designs into a single-use or CMS-driven system architecture.
The Senior UI Developer contributes to the technical development of both internal and client-driven projects. The role will also contribute to the organizational development of the UI Development group by helping to develop processes, technology solutions, and best practices that facilitate development activities. Innovation and flexible thinking are encouraged.This position is located in our downtown San Francisco office and requires no travel.
The Senior UI Developer will:
- Develop expandable, efficient web pages and AJAX applications with a high-degree of cross-platform and cross-browser fidelity from pre-existing, static visual designs
- Develop dynamic web pages and implement design requirements using client-side scripting languages and technologies
- Produce documented, hand-crafted, validated code
- Integrate existing backend systems with existing visual designs
- Act as team lead on larger projects with multiple UI developers
- Act as a mentor and coach to more-junior UI developers
- Bring a self-starting, passionate, detail-oriented approach to all projects
- Remain aware of new technologies that affect front-end web development
- Effectively communicate issues and barriers to assigned project managers and the UI Development Manager
Qualifications / Experience
- Deep knowledge of interactive web design and development tools
- Solid understanding of programming fundamentals, including common design patterns
- Strong professional history of cross-platform and cross-browser web development
- Demonstrated experience working with Flex 2.0+, Flash and ActionScript 2 and 3
- Excellent command of XHTML, CSS and XML
- Demonstrated experience with robust, Object-oriented JavaScript for AJAX application development
- Demonstrated experience with JavaScript Toolkits such as Prototype, Dojo or YahooUI
- Experience with content management systems such as CVS and TeamSite
- Front-end development experience in Java application environments, preferably using MVC architectures
- Extensive experience converting visual designs to XHTML, with an acute eye for detail and design fidelity
- Some experience with graphic editors such as Photoshop, Illustrator, and Fireworks
- Strong communications and mentoring skills
Additional Education/Skills/Experience
- Experience developing for mobile devices, including the iPhone
- Experience working with SOAP data services
- Experience working with JSP, JSTL, and proprietary tag libraries in J2EE environments
- Expert-level knowledge of GREP
- Expertise in Ruby, PHP, or ASP
- Expertise in Content Management System implementation
- Knowledge of multi-media formats and browser plug-ins
Location
San Jose, CA; Walnut Creek, CA;, San Francisco, CA;, Redwood City, CA;, Denver, CO; Pasadena, CA; Corona, CA; Minneapolis, MN; Portland, OR; Seattle, WA; Silver Spring, MD; Plano, TX; Houston, TX; New York, NY; Chicago, IL; Austin, TX
Position Type
Contract, Contract to Hire, and Direct Hire
To apply for this position, email your résumé to Jim Jhanda.
Senior .NET Developer
Job Description / Responsibilities
A well known insurance company is looking for a smart, very experienced .NET developer to join a team of 5-12 people and work on custom application development. This position is open due to growth and the ideal person will be intelligent, analytical and very energetic to get their hands dirty and jump right in as a team leader.
Essential Functions:
- Act as the most senior team lead on a small team varying in size from 5-12 people, and be involved with the mentoring of a few of the more junior developers on the team.
- Provide critical decisions and be given the freedom to suggest alternative development methodologies designed to make key recommendations towards team and application improvements.
- All development will be new and leading edge which directly contributes to this companies success and client retention rate.
- Core programming languages used will be C#, ASP.NET and SQL Server.
Qualifications / Experience
- 5+ years experience in software development and design utilizing Object Oriented technologies.
- 3+ years experience of .NET development experience.
- 1+ years experience with web services development and tools (IDEs, debuggers, prototype, testing tools).
- Bachelors of Science or its equivalent in a technical area of expertise.
- Strong XML Skills
- Must have excellent communication and organization skills
- Must be eager and willing to work with in a dynamic team environment where mentoring is a must!
Bonus Skills and Experiences:
- VB.6
- Classic ASP
- XPATH
- Knowledge of IIS 6.0 techniques such as ASP.NET pipeline
- Exposure to and with SOAP, UDDI, WSDL, COM/DCOM.
Location
San Jose, CA; Walnut Creek, CA;, San Francisco, CA;, Redwood City, CA;, Denver, CO; Pasadena, CA; Corona, CA; Minneapolis, MN; Portland, OR; Seattle, WA; Silver Spring, MD; Plano, TX; Houston, TX; New York, NY; Chicago, IL; Austin, TX
Position Type
Contract, Contract to Hire, and Direct Hire
To apply for this position, email your résumé to Jim Jhanda.
Project Coordinator
Job Description / Responsibilities
You will work with the client's Project Management Office (PMO) that oversees many small to mid size projects using PMI and SDLC methodologies.
You will be responsible support project management planning and controlling activities such as scheduling, risk management, requirements management, cost control, and project reviews. The right person will communicate effectively and excel at bridging professional gaps and will be a catalyst for success in this important and highly visible position.
Key Responsibilities:
- Work with project managers to develop project plans according to defined requirements
- Audit project documentation for completeness and accuracy
- Support and facilitate the process of project management, to include reviewing project artifacts, setting up gate reviews, and maintaining dashboard reports on project status
- Communicate with the project team to get status and update plans
- Work with project stakeholders to ensure requirements are being met
- Use MS Office Products to support the project planning and controlling processes
- Primary duty will be focused on creating construction schedules using Primavera Project Planning software. Must be proficient with using and creating project schedules and budgets in Primavera software.
- Must have specific experience with Critical Path Method (CPM) Scheduling and Earned Value Management (EVM) for small, medium and large Engineering, Procurement and Construction projects.
Qualifications / Experience
- Bachelor's Degree in related area
- Minimum of 6 years of experience working as a project coordinator supporting a project management group.
- Experience with Primavera Project Planning software and MS Office Suite
- Minimum of 4 years of experience in a refining, government or IT project management environment
- Must have excellent communication and written skills
- Must be a team player and have the ability to also work independently
- Highly desired - PMI membership and participation, either PMP or CAPM
Location
San Jose, CA; Walnut Creek, CA;, San Francisco, CA;, Redwood City, CA;, Denver, CO; Pasadena, CA; Corona, CA; Minneapolis, MN; Portland, OR; Seattle, WA; Silver Spring, MD; Plano, TX; Houston, TX; New York, NY; Chicago, IL; Austin, TX
Position Type
Contract, Contract to Hire, and Direct Hire
To apply for this position, email your résumé to Jim Jhanda.
Data Analyst
Job Description / Responsibilities
As a Data Analyst some of your responsibilities will include:
Responsible for analysis and presentation of complex information across all business units globally including roll-up of global information from a variety of sources. Development of complex reports utilizing Oracle Discoverer reporting tool Monitor and track metrics including preparation of monthly, quarterly and annual summary data for business review Training end users in Discoverer report writing Provide ongoing support to the organization globally with reporting and analysis needs including design and implementation of enhanced analytical tools and processes
Qualifications / Experience
Skills - Functional/Technical:
- Bachelors degree in a related subject
- Expert in Structured Query Language (SQL)
- Proficient in the use of PL/SQL
- Demonstrated knowledge of a variety of data reporting, retrieval and analysis tools and processes
- Excellent information analysis skills required
- Ability to use data analysis tools and software effectively
- Strong project management skills
- Ability to use SQL, Oracle databases, Microsoft SQL server, and Oracle Discoverer to analyze large volumes of information, create summary reports and presentations
- Experience managing complex businesses processes required
- Experience using Discoverer Reporting Writing tools
Skills - Quality/Improvement:
- Process improvement focused
- Ability to use quality tools effectively
- Excellent analytical and problem solving skills
- Strong customer service skills
Skills - Teamwork:
- Ability to work effectively with all levels in the organization Strong communication skills (verbal, written, presentation)
- Ability to work effectively across organizations, cultures, global regions
Skills - Leadership:
- Ability to lead improvement projects across organizations and regions
- Ability to maintain confidential information effectively
Location
San Jose, CA; Walnut Creek, CA;, San Francisco, CA;, Redwood City, CA;, Denver, CO; Pasadena, CA; Corona, CA; Minneapolis, MN; Portland, OR; Seattle, WA; Silver Spring, MD; Plano, TX; Houston, TX; New York, NY; Chicago, IL; Austin, TX
Position Type
Contract, Contract to Hire, and Direct Hire
To apply for this position, email your résumé to Jim Jhanda.
Clinical Program Manager
Job Description / Responsibilities
- Provides leadership and therapeutic expertise for the successful management of international clinical trials.
- Participates in development of SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory, safety documents.
- Contributes to development of abstracts, presentations, and manuscripts.
- Contributes to the strategic implementation of a clinical development program(s).
- Provides input into the management of the Clinical Trials Management department.
- Recruit, hire, mentor, and manage CPA/CRA/CPA direct reports and support their professional development.
- Solves problems and uses judgment referring to national and international regulations, guidelines, investigator interactions and timelines.
- Manages international clinical trials within designated program budgets and timelines.
- Initiates and participates in leading departmental or interdepartmental strategic initiatives.
Qualifications / Experience
- BS or BA in a relevant scientific discipline and minimum 10 years relevant clinical experience in the pharmaceutical industry
- Extensive experience in given therapeutic area
- Excellent interpersonal skills
- Ability to lead multifunctional teams
- Ability to manage staff and mentor junior staff
- Effectively solves problems and uses judgment relating to national and international regulations, guidelines, investigator interactions and timelines
- Must possess a proven ability to successfully develop, implement, manage and complete clinical trials and manage vendor relations
- Extensive experience in developing RFPs, selection of CROs/vendors, and management of external resources
- Demonstrated ability to manage international clinical trials within designated program budgets and timelines
- Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers
- Ability to initiate, participate in and/or lead departmental or interdepartmental strategic initiatives
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
SAS Applications Manager (IT Lead Analyst)
Job Description / Responsibilities
- Provide oversight to assigned SAS programmers for the project, both internal and contract;
- Participate as a member of Study Management Teams and assist in the development of case report forms, data validations, and data quality plans;
- Lead the development and documentation of mapping specifications for the creation of standard analysis data sets;
- Act as contact person within Biostatistics dealing with Data Management;
- Implement report specifications as defined in statistical analysis plans and respond to ad-hoc requests to produce reports for Clinical customers (tables, listings and graphs);
- Design robust, flexible, and modular software for the project;
- Direct team members in creation of individual components;
- Oversee integration testing of the entire project software suite;
- Administer standard validation requirements by: managing code reviews, applying a development-QA-production code development lifecycle, authoring and/or reviewing validation plans and reports;
- Act as contact person within Biostatistics dealing with the exporting of data to the Electronic Submissions group as well as others dealing with Genetics and Pharmacoeconomics;
- Act as contact person within Biostatistics with outside companies on data and programming issues;
- Maintain up-to-date project documentation.
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.
Qualifications / Experience
- BS/BA in computer science, mathematics, statistics or related areas of study.
- In-depth knowledge of SAS programming with at least 5 years of experience in a pharmaceutical industry biostatistics environment.
- Strong knowledge of SAS Macro.
- Knowledge of clinical data processing, with emphasis on regulatory agency requirements for data reporting.
- Understanding of data and system dependencies, experience in integration of studies (ISE and ISS) and validation techniques.
- High level of accuracy and attention to detail.
- Ability to work in a team environment and good communication skills.
- Knowledge of UNIX (including basic shell scripting) and experience leading other programmers a plus.
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Program Director-Drug Regulatory Affairs CMC
Job Description / Responsibilities
- Provides regulatory strategic direction related to chemistry, manufacturing and controls to the regulatory and/or technical leader(s) and their respective global development team or US product team.
- Takes a leadership role, as appropriate, on project team(s) and within the function to resolve critical issues and meet business objectives.
- Serves as a principal interface with FDA CMC reviewers and directs FDA interactions with technical teams.
- Develops CMC regulatory strategies and prepares associated regulatory submissions.
- Coordinates activities of global PDR personnel and cross-functional teams to ensure that tasks are completed within defined due dates and meet regulatory and departmental guidelines.
- Proactively and independently manages special regulatory projects of high complexity.
- Mentors PDR personnel and updates appropriate departments on current regulatory environment.
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point.
Qualifications / Experience
- MS degree or BA/BS and scientific research experience
- 5+ years relevant experience in drug development and regulatory affairs
- Expert knowledge of core processes in pharmaceutical development: discovery, development, manufacturing, and marketing
- Excellent communication and organizational skills
- Proven teamwork and interpersonal skills
- Strong leadership skills
- Commitment to performance measures of time, cost, and quality
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Global Clinical Study Manager
Job Description / Responsibilities
- To provide leadership to one or more global Study Management Teams (SMTs) and ensure the effective and efficient delivery (leading to and including DRAM specified outputs) of one or more studies in accordance with the Clinical Development Plan and ICH/GCP standards.
- Provides direction and leadership to one or more SMTs.
- Builds effective, high performing SMTs through influence, integration, motivation and optimizing team performance.
- Embeds the Roche values into the team(s) culture and promotes the team spirit.
- Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders and co-development partners, eg, OPLs, Project Data Managers and non-PDOC functional management.
- Represents the SMT(s) at the Clinical Team at the request of the Operations Project Leader (OPL).
- In collaboration with functional management, coaches and supports team members to ensure performance is optimized Ensures SMT receives therapeutic area training.
- Develops scenario plans that deliver the studies on time, with the most efficient use of budget and resources.
- Establishes study timelines, budget, resource, risk and quality plans Leads the development of the protocol feasibility questionnaire with cross-functional input.
- Finalizes country selection for studies across project with consultation from the OPL.
- Oversees the drug supply requirements and availability across studies in liaison with the Global Trial Coordinator.
- Ensures that the SMT(s) has the appropriate resources to effectively deliver high quality studies on time and within budget.
Qualifications / Experience
- Life science degree Strong leadership skills developed through leading global multi-functional matrix study teams through all stages of clinical studies and highlighted by a consistent achievement of team delivery against commitments and goals.
- Experienced project manager, having led the development and implementation of risk management plans, managed complex study budgets and resourcing plans.
- Proven experience of all aspects of clinical studies including vendor/CRO management, leading/working as part of a HQ development team, implementation of clinical development plans and coordinating study level activities to deliver data for filing or publication purposes.
- Experience of influencing and negotiating at all levels to achieve team delivery.
- Self-motivated and achievement driven.
- Excellent written and verbal communications skills demonstrated by an ability to present clear messages from complex information/data to all levels in the
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Statistical Leader
Job Description / Responsibilities
The successful candidate will direct and perform statistical analyses and interpretation of data and be responsible for all statistical aspects of a clinical project or distinct portion of a project through the NDA submission and its defense. The candidate will utilize relevant computer languages and software packages, as well as develop and write programs, using new statistical methods and analytical procedures, to analyze clinical trial data. Advise and lead team members who perform similar projects. Candidate must also review and write statistical sections, sign off protocol before official approval, and represent Roche before regulatory bodies.
Qualifications / Experience
- MSc (or equivalent) or PhD in Statistics or very similar area.
- At least 8 years pharmaceutical industry experience in Biostatistics and clinical drug development
- Comfortable with Computers; can readily learn new software applications
- Experience in using statistical software (particularly SAS) as well as knowledge of database and interface systems.
- Very good English language skills.
- Travel may be required
- Communicates clearly and effectively in written reports, data presentations and meetings as required.
- Establishes and maintains good working relationships; is co-operative. Takes cultural and value differences into account in dealings with others.
- Leadership skills and an international perspective
- Experience in oncology clinical trials is desirable.
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Medical Director-Rheumatology
Job Description / Responsibilities
- Provide scientific and team leadership to a multi-functional medical team in order to ensure an effective impact and implementation of the medical plan.
- Accountable for ensuring the scientific validity of content messages in product publications. Effectively communicates (to/from Medical Team) information, plans and decisions from other teams and functions within our organization (i.e., Life Cycle Team, the International Medical Manager, Pharma Development, etc.)
- Works collaboratively with key medical and marketing colleagues and others (i.e., Medical Liaisons, Field Sales, Product Team, Development, Consultants etc.).
- Responsible for communicating plans and strategies between the Medical Team and the Product Team to ensure alignment and the confidence that the medical plan and tactics optimally support the product’s goals and strategies.
- Accountable for ensuring alignment of scientific publications with intended messages.
- Accountable to motivate team members to work effectively in a matrix environment. Responsible for open and constructive dialogue within the team in a manner that supports a high level of team and individual performance.
- Responsible for creating an environment of trust, mutual respect and accountability and communicating ideas and opinions in a non-judgmental manner that encourages feedback and constructive debate.
Qualifications / Experience
- M.D. with rheumatology experience and publication with rheumatology is required.
- Industry experience and/or clinical research in rheumatology is preferred.
- Excellent communication skills is a must.
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Medical Science Liaison
Job Description / Responsibilities
- Field-based professional who provides medical and technical expertise to ensure awareness and appropriate use of Roche products to designated physician audiences and other medical professionals, as well as establishes and maintains Roche relationships with current and future innovators and opinion leaders within the oncology communities.
- Accomplishes awareness and appropriate use through interactions with and data presentations to key physicians, advisory board moderation, speaker training, and various research initiatives.
- Acts as medical liaison between the customer and the Roche Organization.
- Performs site screenings(s) and evaluations(s) for potential Phase IIIb and IV clinical trials with Roche products.
- Provides feedback to Clinical Development and supports business management as issues of clinical significance arise with the Roche product line.
- Provides leadership on external projects and selected internal projects.
- Supports sales specialist training initiatives.
Qualifications / Experience
- MD, PharmD, or PhD preferred with 3-5 years of clinical work experience in oncology.
- Previous/current ML experience is a plus.
- Strong written and verbal communication skills with demonstrated competency in group presentations is required.
- Must be able to work independently and in collaboration with others, as well as demonstrate the ability to influence others.
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Associate/Director - Regulatory Affairs
Job Description / Responsibilities
- Global Regulatory Leader on global Life Cycle Teams [core Life Cycle Team member with accountability equal to other core team members (CSL, OPL, etc. or CERA)] or US Regulatory Leader on highly complex/business critical projects [e.g., products with large phase 3 programs or extensive life cycle management plans (Xeloda, Pegasys, etc.)]
- Provides regulatory leadership to a cross-functional global life cycle team (LCT)/US Product Team and regulatory subteam (RAFT).
- Leads the team (LCT and RAFT) in developing, implementing and delivering a global regulatory strategy for highly complex products which balances time, cost, quality and risk and which meets the needs of patients, prescribers, payers, regulators and Roche Business for an optimal label to commercialize our products.
Qualifications / Experience
- Masters Degree or equivalent
- 8+ years relevant experience in regulatory affairs
- Demonstrated expertise in leading global strategic regulatory development of products from entry into man through life cycle management across therapeutic areas/product classes.
- Demonstrated expertise in leading/delivering global original IND/NDA/MAA filings and management of filing review process across therapeutic areas/product classes.
- Demonstrated command of core competencies listed
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Associate Clinical Director - Oncology
Job Description / Responsibilities
You will be responsible for assisting the clinical science leader in all areas of project and study planning, evaluation, documentation including IND and annual report, clinical NDA preparation and protocol preparation. You will have responsibility for the full life cycle of at least one study.
Principal responsibilities:
- Assists in the timely medically and scientifically sound development of the clinical portions of a product development plan (PDP) the quality and timely preparation of all PDM documents submitted for approval GCP, Clinical Operating Guidelines and Standard Operating Procedures are followed within PDC and liaises with appropriate departments inside and outside PDC to define the timing of discussion with the FDA and other regulatory bodies on format of clinical NDA and submission issues.
- Preparation of clinical progress reports for regulatory agencies before they are reviewed by line-managers and assures the consistency of labeling and package insert (clinical section) with database.
- The preparation and contents of annual reports and safety updates and ensures corrects data interpretation including interim and Final Study Reports before they are approved and assumes protocol authorship, selects the efficacy parameters, defines the range of laboratory marked abnormality values and acceptable laboratory reference values and assumes the development and writing of protocols.
- Task priorities and schedules within a project as well as time schedule in view of the next assessment point for PDM relevant sections or selects, in liaison with other departments, suitable clinical consultants when required and represents PDM at monitoring workshops when required and contributes to Project Specific Manual for clinical sections and assures that the SOPs for evaluation, documentation and reporting of SAEs are strictly followed within PDM and together with PDS assesses the etiology/causality of SAEs and laboratory abnormalities and liaises and communicates with Marketing and co-ordinates clinical efforts on the project related issues.
- Preparation of abstracts, posters, oral communication for scientific meetings reviewing license applications as requested by Group Leader and contributes to the career development plans of his/her collaborators and actively ensures that they receive appropriate management and technical support and training. Contributes to orientation and training for employees and signals further educational or training requirements and selects, interviews and makes hiring recommendations in reporting area and conducts performance appraisals of subordinates.
Qualifications / Experience
- Medical Degree
- Sub-specialization in hematology and/or oncology, equivalent to “board-eligible” in hematology and/or oncology in US
- Experience in clinical research, preference will be give to candidates with clinical research experience in Pharmaceutical industry
- Ability to interact well in a team setting
- Fluent in English
- Able to travel frequently
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Sr. Clinical Compliance Specialist
Job Description / Responsibilities
Principal responsibilities:
- Maintains strong working relationship with clinical project teams.
- Schedules,coordinates and/or participates in routine audits of investigator sites, vendors, internal systems/processes, and internal documents.
- Follow-up of corrective action plans as required.
- Provides support as needed during regulatory inspections.
- Provides GCP guidance and training internally and at investigator meetings.
- Reviews protocols, ICFs, and other documents as requested.
Essential Duties and Job Functions:
Responsible for maintaining current knowledge of Compliance program and of applicable company standard operating procedures for areas of responsibility. Area of responsibility may be limited to Clinical Compliance, Laboratory Compliance, and Electronic Systems Compliance. Maintains strong and productive working relationships with assigned groups. Maintains strong working relationships with compliance/quality groups of vendors or business partners. Follows-up on questions from assigned departments. May assist in implementation of standard operating procedures and systems needed to comply with regulatory requirements. Responsible for completion of assigned audits. May, with guidance, lead specific types of audits. Audits may include internal systems audits, external vendor audits, or document reviews. May implement procedures and audit tools for the conduct of internal and external audits. May coordinate audit follow-up and corrective action planning with appropriate functional areas. May provide support during regulatory agency inspections. Work is performed under minimal supervision of Compliance professional.
Qualifications / Experience
- Typically requires a BS degree in a scientific discipline with minimum 6 years of relevant experience in the pharmaceutical quality control, quality assurance or compliance environment, or a MS degree in a scientific discipline with minimum 4 years of relevant experience in the pharmaceutical quality control, quality assurance or compliance environment.
- Must consistently meet standards required in Compliance.
- Good verbal, written and interpersonal skills are required.
- Must have a working understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
- Must posses excellent organizational skills.
- Good attention to detail.
- Good computer skills in MS Word, Outlook, Excel and PowerPoint.
- Must be able to meet deadlines yet be flexible.
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Manager/Senior Manager, Drug Safety
Job Description / Responsibilities
Specific responsibilities:
- Responsible for safety evaluation work for specified product(s), including signal detection and workups, proactive management of potential safety issues, labeling documentation, Periodic Safety Update Reports and other periodic reports, risk management plans and responses to regulatory agency safety inquiries.
- Collaborates closely with the safety physician responsible for the specified product(s).
- Collaborates with partner companies on safety evaluation for co-licensed products
- Participates in safety committee meetings (internal or with partner companies)
- Takes the lead for assigned projects and is fully responsible for all activities relating to them.
Essential Duties and Job Functions:
- Identifies and pursues global and long-term goals for the group, in consultation with department head.
- Works independently, establishing work priorities and direction with minimal input
- Takes lead and is responsible for (a) specific project(s), such as database support, MedDRA coding, risk management activities, compliance activities or (a) therapeutic program(s), and is fully responsible for all activities relating to it.
- Develops and provides training on the principles and practices of drug safety to Gilead personnel or to external groups such as investigators or Contract Research Organizations.
- Participates in strategic planning, workflow development, SOP updates, audits, data analysis and team meetings pertaining to their projects.
- May review and prioritize information received on adverse events for both marketed and pre-marketed products.
- May be required to conduct and oversee inspections of safety reporting systems and procedures to ensure the quality, integrity and compliance with regulations relevant to Pharmacovigilance and Safety reporting requirements.
- May assist with safety updates for labeling.
- May co-ordinate and prepare sections of relevant PSURs and other periodic safety reports.
Qualifications / Experience
Drug safety skills and requirements:
- At least 3 years of drug safety evaluation and risk management experience.
- Must have a well developed scientific and analytical knowledge base.
- A systematic and logical approach to problem solving, combined with good judgment.
- Must have an excellent attention to detail combined with an ability to present complex information clearly (in verbal and written form).
- In depth understanding of good pharmacovigilance practices and current drug safety regulations.
- Experience of writing drug safety SOPs and participation in drug safety audits
Other skills and requirements:
- Able to work independently, establishing work priorities and direction with minimal input.
- Able to work effectively in a team.
- Sufficient skill and confidence to make significant contributions to strategic planning within the drug safety department
- Must have a strong attention to detail, teamwork and initiative.
- Must be able to interact with other departments within the company, and be proficient in e-mail and verbal communication.
- Must have an in depth scientific and analytical knowledge base, and an in depth understanding of good pharmacovigilance practices and current regulations within drug safety.
- Previous experience and understanding of a drug safety database is required.
- Must be proficient in Microsoft Excel, Power Point and Word.
- Typically requires a BS degree in life sciences, pharmacy, nursing and minimum 10 years of relevant experience which includes 6 years in drug safety or 6 years relevant experience in database management, coding, SOP writing, QC, compliance, or risk management.
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Clinical Data Manager
Job Description / Responsibilities
- This position will be responsible for primarily managing outsourced trials from a Data Management perspective, and also managing trials that are conducted internally with global staff.
- Provide timely and professional ongoing management of clinical trial data, Phases I to IV, by preparing or reviewing Data Management Plans and chairing review meetings.
- Prepare material for and presenting at Investigator meetings, identify errors and inconsistencies in CRF data and ensure their resolution.
- Performing serious adverse event and external data reconciliation e.g lab data, in order that databases can be declared clean and locked according to strict quality standards.
- Maintain Project Management oversight on all outsourced trials and server as primary point of contact on Data Management for the Clinical Trial Team.
- In addition, to represent the DM function in International Clinical and Program Teams, to define program as well as trial level Data Management strategy and ensure that the successful execution of this strategy.
Qualifications / Experience
- Degree in life sciences, pharmacy, nursing (e.g. SRN in UK) or equivalent relevant experience.
- Typically 2 or more years experience in drug development, including 1 or more years in the discipline of Clinical Data Management
- Experience working with CROs
- Good understanding of clinical trial methodology, GCP and medical terminology
- Good computer skills using CDMS such as Oracle Clinical, Clintrial, Inform, MediData Rave, SAS, Integrated Review, etc.
- Attention to detail
- Good organizational and project management skills
- Good interpersonal and communication skills and the ability to operate effectively in an international environment
- Good understanding of physiology, pharmacology, clinical study objectives and the drug development process.
- Good problem solving skills.
- Good presentation skills
- Ability to work as part of a team and without close supervision.
- Ability to work under pressure and meet timelines.
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Brand Safety Leader
Job Description / Responsibilities
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us the most rewarding employer in our field.
We are looking for a Brand Safety Leader responsible for safety issue management from end of Phase I (POC) through Life Cycle Management.
- Responsible for overall signal detection, monitoring,evaluation,interpretation and appropriate management of safety information, based on information from all relevant line functions, postmarketing data, and other sources.
- Develops and updates, at milestones, the safety profiling and risk management plan from end of Phase I (POC) through Life Cycle Management as relevant.
- Leads IPT Safety Subteam.
- Serves as safety representative on International Clinical Team (and IPT).
- Manages Drug Safety Monitoring Board activities for assigned projects/products, as required.
- Responsible for initial development and updates of safety information in Basic Prescribing Information (core global labeling),including addressing safety issues optimally in all project/product labeling claims.
- Responsible for responses to inquires from regulatory authorities or health care professionals on safety issues.
- Prepares safety data for health authority review boards.
- Responsible for responses to legal queries and CPO requests involving safety issues.
- Ensures safety information communicated to EU Qualified Person in a timely fashion.
- Provides integrated safety input into all regulatory documents required during active development
- Reviews and provides integrated safety input into clinical study protocols and clinical study reports, including Brand Optimization studies
- Co-ordinates involvement of external experts (e.g. authors of “white papers”, members of trial-specific data safety monitoring boards, ad-hoc support for HA meetings, etc.)
- Prepares and may present brand safety issues to internal Novartis Boards and other meetings
- Provides relevant input for IPT, ICT and TA Expert Panel meetings, as needed
- Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.
- Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.
- Serves as and performs activities of Pharmacovigilance Leader as needed.
Qualifications / Experience
- Education (minimum/desirable): Medical degree required, Specialty Board certification desirable. Useful additional degrees: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent)
- Languages: Fluent in spoken and written English,
- Understanding in another language (e.g. French, German, Spanish) desirable.
- 3 years clinical experience postdoctoral
- At least 5 years are in drug development in a major pharmaceutical company (of which 2 years in a gobal position), including 2 years in safety at an operational or medical position-
- Experience in preparing or contributing to preparation of clinical safety assessments and regulatory re-ports/submissions involving safety information.
- Experience in leading cross-functional, multi-cultural teams
- Experience with (safety or others) issue management
- Experience in drug development, clinical trial method-ology, regulatory requirements, scientific methodology,statistics and writing of publications
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Senior Clinical Regulatory Affairs Associate
Job Description / Responsibilities
Purpose of the Position:
- Prepares and facilitates meetings/teleconferences with regulatory agencies.
- Advises team members on applicability of new regulations and guidelines.
- Also responsible for the maintenance of various clinical and nonclinical regulatory documents, including INDs/BLAs/NDAs.
- Ensures that the elements, quality, accuracy and format of regulatory submissions comply with applicable laws, regulations and corporate standards.
- Represents regulatory affairs at subteam meetings.
Principal responsibilities:
- Serves as the regulatory representative on various project subteams and addresses a broad range of problems of moderate scope
- Documents teleconferences and meetings with health authorities
- Participates in department initiatives, task forces, and training
- Collaborates with the regulatory information, CMC and commercial groups of Regulatory Affairs
- Works on computer for extended periods of time
- Manage project plans and timelines for multiple projects
- Perform literature searches, prepare special reports and assemble documentation to support project teams
- Any other tasks as requested by management to support business activities
- Works under limited direction and guidance
- Applies knowledge of FDA regulations and ICH guidelines to provide regulatory guidance and contribute to strategic planning on project teams
- Develop and maintain departmental processes, policies, SOPs and associated documents
- Provide guidance to and train associates on standardized departmental processes
- Lead or participate in department initiatives, task forces, and training
Competencies Identified for Success:
- Applying technical expertise
- Building and leading teams
In addition to those identified for a Regulatory Affairs Associate which include:
- Collaboration and teamwork
- Communication
- Driving for results
- Process management
Qualifications / Experience
Minimum requirements:
- Education: Bachelor's degree in science required
- Years of Experience: Five - seven years drug development experience including a minimum of one year of regulatory affairs experience
- Skills: Ability to work independently, problem solving, strong technical experience, and conflict resolution. In addition to those skills identified for a Regulatory Affairs Associate which include strong oral and written communication, attention to detail, and ability to prioritize and implement multiple activities/projects, adherence to timelines, flexibility and willingness to adapt in a changing environment
Preferred requirements:
- Two or more years experience in regulatory affairs
- Advanced degree
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Quality Assurance Auditor - GCP
Job Description / Responsibilities
- Applies a complete and technical understanding of both Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) and regulations to independently address a variety of complex issues associated with drug development. Has expert knowledge of and is able to apply the FDA and USDA regulations and Guidance and other regulations including HIPAA Privacy Rule, CLIA regulations, OECD, and other international rules.
- Coordinates and assigns audits. Performs assigned audits which include internal GLP and GCP system audits, external GLP and GCP vendor audits, Clinical Investigator Site Audits, and reviews of documents to be submitted to regulatory authorities. During audits, identifies compliance risks and reports findings to appropriate management with recommendations for resolution. Understands and evaluates clinical sites for compliance with the requirements for informed consent forms, case report forms, and essential documents for the trial master files and regulatory affairs files.
- Performs or reviews complex literature/database searches for additional or supporting compliance information, when appropriate. Uses this information to provide well-informed audit findings and recommend corrective/preventive actions, develop compliance opinions, and provide education or training to GLP and GCP functional areas. Researches and writes formal CCG Compliance Opinions or provides other verbal/written guidance on complex compliances issues. Reviews Compliance Opinions prepared by E2 and E3 prior to distribution.
- Has considerable latitude in determining objectives and approaches to problem solving. Regularly interacts with co-workers, management, Development personnel and partners in other GNE departments (e.g., Legal, Regulatory Affairs) regarding compliance issue resolution and system improvements. Demonstrates ability to influence and negotiate effective solutions. Develops specific audit plans, leads, independently performs, or trains other auditors to perform complex compliance audits and facilitates resolution of audit issues. Coordinates compliance projects. Assists CCG management with strategic planning.
- Represents CCG to Development through activities such as CCG Molecule Lead (including implementation team [IT) membership) and CCG Liaison to Pharm SubTeams.
- Assists the Inspection Management team during FDA or other regulatory authority inspections of GNE Development studies. Such assistance may include document retrieval/review and preparation/training of perspective interviewees.
- Internally provides training presentations in audit or regulatory trends, procedures for audit responses, and other topics. Provides compliance guidance to all audited parties to encourage process improvements. Externally presents GCP training at Investigator Meetings. Is a recognized trainer of CCG auditors.
Qualifications / Experience
- Highly skilled auditor who demonstrates an in-depth understanding of complex regulations, guidelines, quality systems, and compliance issues. Is proficient as lead auditor or trainer in at least two audit areas (i.e. GLP vendor, Clinical Site/GCP vendor audits).
- Has proven ability to assimilate new and emerging compliance information or trends. Serves as an internal consultant in interpretation of regulatory requirements and expectations.
- Excellent verbal, written communication skills, and presentation skills.
- BA/BS in life sciences (MS, RN or pharmacy degree preferred), at least 7 years of industry experience, and 3 to 5 years of compliance experience.
OR
At least 9 years industry experience, and a minimum of 7 years compliance-related experience.
- This job requires at least 50 percent travel (including international travel) for auditing work, plus travel to Genentechs South San Francisco corporate headquarters as needed.
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
Drug Safety Medical Writer II
Job Description / Responsibilities
Summary of Position:
The Drug Safety (DS) Medical Writer II is responsible for coordinating and participating in the production of DS medical, regulatory, and other controlled documents in the DS department.
Principal responsibilities:
- Actively coordinate and participate in the production of periodic and ad hoc DS medical and regulatory reports including, but not limited to, safety sections of Clinical Study Reports and health authority submissions, periodic safety update reports, and issue work-ups. This includes writing, editing, and coordinating production of adverse event narratives and safety-related documents.
- Create and maintain departmental and safety-related document templates and controlled documents as needed.
- Proactively review and understand Genentech molecules and protocols (where applicable) that are associated with specific writing projects to facilitate efficient and effective handling of data and document structure.
- Effectively communicate new developments within the regulatory writing field to internal and external groups (e.g., Regulatory, Clinical Science, Development Editing) to ensure overall compliance with industry standards.
- Participate in committees, departmental initiatives, clinical team filing activities, and special projects in collaboration with DS management.
- Effectively interact on multiple projects working independently as well as within intra- and inter-department functional teams.
- Maintain effective communication with and influences all levels throughout a highly matrixed organization, and builds successful working relationships across disciplines.
Competencies Identified for Success:
- Excellent verbal and written communication skills, organizational skills, and time and resource management skills.
- Able to partner effectively with internal and external partners in a proactive, positive and constructive manner
- Able to manage multiple projects and timelines, and accommodate multiple priorities in a fast paced and changing environment.
- Organized and detail oriented, demonstrates a high level of commitment and drive for excellence, and generates enthusiasm
- Strong collaboration, communication and leadership skills to effectively and clearly coordinate across multiple functional areas with a diverse group of team members
Qualifications / Experience
- Bachelors degree in Science or Business-related field; clinical education and experience preferred.
- Minimum five years of medical writing or equivalent experience.
- Highly skilled in Microsoft Office applications, Adobe Acrobat, PowerPoint, and other relevant applications for writing, editing, development of controlled documents, etc.
- Knowledge of biotechnology/pharmaceutical industry, the clinical drug development process, and drug safety preferred.
- Knowledge of regulatory requirements and ICH Guidelines as related to regulatory writing.
Location
Position Type
To apply for this position, email your résumé to Michelle Miller.
