Reference #: JR5363SUMMARY/JOB PURPOSE:

　　Writes and edits various documents to support Clinical Development. Such documents may include clinical study reports (CSRs), common technical document (CTD) summaries for submission to regulatory agencies, protocols, Investigator Brochures, literature reviews, study manuals, and standard operating procedures (SOPs). Assembles CSR and CTD summary appendices and narratives.

　　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.Assembles CSR and CTD summary appendices and narratives.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:

　　No direct reports.May provide mentoring to less experienced medical writers.

　　EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

　　Education/Experience:

　　BS/BA degree in related discipline and a minimum of nine years of related experience; or,MS/MA degree in related discipline and a minimum of seven years of related experience; or,PhD in related discipline and a minimum of two years of related experience; or,Equivalent combination of education and experience.May require certification in assigned area.

　　Experience/The Ideal for Successful Entry into Job:

　　Experience in Biotech/Pharmaceutical industry preferred.Prior medical technical writing experience within the biotech/pharmaceutical/CRO realm.Experience and significant participation in leading the preparation of clinical documents for regulatory submissions (e.g. clinical protocols, INDs, NDAs, BLAs).Experience and use of electronic literature tools to obtain reprints of abstracts and medical publications

　　Knowledge/Skills:

　　Familiarity with therapeutic area of oncology.Provides guidance to teams based on organizational goals and company policy, with responsibility for results.Excellent writing ability.Ability to develop complex documents with a high degree of independenceProficient in Windows suite.Ability to incorporate diverse feedback into a high-quality document.Performs a variety of complicated tasks with a wide degree of creativity and latitude.May provide direction to teams based on general policies and management guidance.Determines methods and procedures on new assignments.Has wide-ranging experience in area of specialization.Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.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 issues where analysis of situations or data requires an in-depth evaluation of variable factors.Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.Networks with key contacts outside own area of expertise.

　　#LI-JD1

　　If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

　　Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets.  The base pay range for this positionis $133,000 - $189,750 annually. The base pay range may take into account the candidate's geographic region, which will adjust t e pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

　　In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.  Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.  Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

　　DISCLAIMERThe 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.