Exelixis Inc
Associate Director, Medical Writing (Finance)
Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
Job Description
Writes and edits clinical study reports (CSRs) and common technical document (CTD) summaries for submission to regulatory agencies and prepares other regulatory and clinical trial documentation as necessary. Compiles, analyzes, and summarizes data from statistical tables and other sources as needed. Assembles CSR and CTD summary appendices and narratives. Requires knowledge of product areas, current developments, and keeping abreast of current literature.
Qualifications
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Writes and edits CSRs, CTD summaries and other clinical trial documentation as necessary for submission to the Food and Drug Administration (FDA) or other regulatory agencies or for in-company use. May include supervision of other writers or colleagues.
• Assembles CSR and CTD summary appendices and narratives.
• Prepares monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication.
• Edits, rewrites, or otherwise prepares drafts of Clinical Protocols and Investigator Brochures.
• Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed.
• Writes and maintains files on informative journal abstracts according to current or estimated future needs.
• Study contact on relevant regular and ad hoc project teams as required.
• Integrates various sources of information into a uniform style and language for regulatory compliance.
• Other duties as needed.
SUPERVISORY RESPONSIBILITIES:
• Will have direct reports.
EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline and ten years of related experience; or,
• MS/MA degree in related discipline and eight years of related experience; or,
• PhD in related discipline and six years of related experience, or;
• Equivalent combination of education and experience.
• May require certification in assigned area.
Experience:
• Experience in Biotech/Pharmaceutical industry preferred.
Knowledge/Skills/Abilities:
• Six to eight years of medical writing or equivalent writing experience in the pharmaceutical industry.
• Experience and significant participation in preparation of documents for regulatory submissions (e.g., clinical protocols, INDs, NDAs, BLAs, CTDs).
• Familiarity with therapeutic area of oncology is essential.
• Experience and use of electronic literature tools to obtain reprints of abstracts and medical publications.
• Familiarity with document management systems is essential.
• Performs a variety of complicated tasks with a wide degree of independence, creativity and latitude.
• Determines methods and procedures on new assignments.
• Has extensive experience in relevant industry/profession and area of specialization.
• Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Identifies and implements methods and procedures to achieve results.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude. May be responsible for the work of other writers.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
JOB COMPLEXITY:
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. High degree of independent work required.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
• Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Networks with key contacts outside own area of expertise.
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Additional Information
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.