Senior Medical Writing Director: Leading Clinical Content

1 week ago

Alameda, California, United States Exelixis Full time

Job Summary:

We are seeking a highly experienced Senior Medical Writing Director to lead our clinical content team at Exelixis. As a key member of our regulatory affairs team, you will be responsible for writing and editing various documents to support product development.

About the Role:

  • You will write and edit clinical study reports (CSRs), common technical document (CTD) summaries, protocols, investigator brochures, literature reviews, and other clinical trial documentation.
  • You will assemble CSR and CTD summary appendices and narratives, ensuring that all documents meet regulatory requirements.
  • You will propose and manage timelines for document preparation and review, ensuring timely completion of projects.
  • You will compile, analyze, and summarize data from statistical tables and other sources as needed.
  • You will integrate various sources of information into a uniform style and language, maintaining regulatory compliance.
  • You will serve as a medical writing expert on regular and ad-hoc study, program, or project teams.
  • You will lead and manage teams of medical writers in complex projects, providing guidance based on organizational goals and company policy.
  • You will perform quality checks of documents prepared by other medical writers as needed.

Required Skills and Qualifications:

  • You must have a BS/BA degree in a related discipline and a minimum of 15 years of related experience, or an equivalent combination of education and experience.
  • You must have excellent writing ability with strong attention to detail, knowledge of ICH guidelines, and familiarity with therapeutic areas such as oncology.
  • You must be proficient in Windows suite and have experience using electronic literature tools to obtain reprints of abstracts and medical publications.
  • You must be able to independently develop high-quality complex documents and direct a variety of complicated tasks with strategic flair.

Benefits:

  • The estimated salary range for this position is $192,500 - $273,000 annually, depending on the candidate's geographic region, job-related knowledge, skills, experience, and internal equity.
  • We offer a comprehensive employee benefits package, including a 401(k) plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
  • Employees are eligible for a discretionary annual bonus program and may also purchase company stock.

About Us:

Exelixis is an equal opportunity employer and does 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, or basis of disability or any other federal, state, or local protected class.

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