Senior Medical Writing Director

SUMMARY / JOB PURPOSE :

Writes and edits various documents to support Product 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. Requires knowledge of company policies and technical platforms, product areas, current developments, and keeping abreast of current literature.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Writes and edits CSRs, CTD summaries, protocols, investigators brochures, and other clinical trial documentation as necessary for submission to regulatory agencies and other stakeholders or for in-company use.
• Proposes and manages timelines for document preparation and review
• Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed.
• Integrates various sources of information into a uniform style and language for regulatory compliance.
• Assembles CSR and CTD summary appendices and narratives
• Serves as the MW expert on regular and ad hoc study, program, or project teams.
• Leads and manages teams of medical writers in complex projects by providing guidance based on organizational goals and company policy, with responsibility for results.
• Guides and advises Medical Writing contributors as a function of program representation. This responsibility may include document review.
• Performs quality checks of documents prepared by other medical writers as needed.
• Proposes opportunities for process improvement and leads projects to enhance efficiency and optimize the use of resources
• Other duties as needed.

SUPERVISORY RESPONSIBILITIES :

• No direct reports
• Provides asset-level strategic guidance to study-level MW representatives
• Mentors less experienced medical writers
• Supports and directs the work of contract medical writers

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education / Experience :

• BS / BA degree in related discipline and a minimum of fifteen years of related experience; or,
• MS / MA degree in related discipline and a minimum of thirteen years of related experience; or,
• PhD in related discipline and a minimum of twelve 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 required.
• Nine to eleven 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).
• Experience and use of electronic literature tools to obtain reprints of abstracts and medical publications.

Knowledge / Skills :

• Familiarity with therapeutic area of oncology is essential.
• Good / general knowledge of the AMA Manual of Style, ICH guidelines, Regulatory Affairs, and Clinical Development.
• Excellent writing ability with strong attention to detail.
• Proficient in Windows suite.
• Ability to independently develop high-quality complex documents
• Familiarity with document management systems is essential.
• Directs a variety of complicated tasks with a wide degree of strategic flair (eg, by direct contact with personnel at other organizations), independence, creativity, and latitude.
• Identifies and implements methods and procedures to achieve results.
• 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.
• Has good timeline development and management skills
• Applies strong analytical and business communication skills.

JOB COMPLEXITY :

• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. High degree of independent work and strategic flair 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.

WORKING CONDITIONS :

Environment : primarily working indoors, performing clerical work

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 $192,500 - $273,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the 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.

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.