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Exelixis

Associate Regulatory Scientific Communications Director

Content WriterContent WriterFull TimeRemoteTeam 1,001-5,000Since 1994H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

$148.5K - $209.5K / year

Bachelor Degree11 yrs expEnglishAssembly

Job Description

• Leads content development for various regulatory and clinical documents • Composes, develops, reviews, and edits content • Integrates various sources of information into a uniform style • Compiles, analyzes, and summarizes data from statistical tables • Assigns and supervises partner regulatory editors for document tasks • Proposes and manages timelines for the document development process • Oversees the assembly of appendices for regulatory submission documents • Provides writing guidance to internal teams • Peer reviews project work and training materials • Contributes to SOP and work instruction development

Job Requirements

  • BS/BA degree in related discipline with a minimum of eleven years of related experience, or MS/MA degree with a minimum of nine years, or PhD with a minimum of five years, or equivalent combination of education and experience
  • Active AMWA member with certificate or certification preferred; BELS certification a plus
  • Experience in Biotech/Pharmaceutical industry preferred
  • Prior regulatory/medical/technical writing experience
  • Experience and significant participation in leading content development for regulatory and clinical documents for regulatory submissions
  • Experience and use of electronic literature tools
  • Familiarity with therapeutic area of oncology
  • Advanced knowledge of the drug development process and regulatory requirements
  • Advanced knowledge of AMA style, medical terminology, and clinical data analysis
  • Strong interpersonal skills

Benefits

  • 401k plan with generous company contributions
  • Group medical, dental and vision coverage
  • Life and disability insurance
  • Flexible spending accounts
  • Discretionary annual bonus program
  • Opportunity to purchase company stock
  • Long-term incentives
  • 15 accrued vacation days in first year
  • 17 paid holidays including a company-wide winter shutdown in December
  • Up to 10 sick days throughout the calendar year

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