Manager, Content Strategy and Development (Medical Writing)- Oncology

Gilead Sciences • Foster City, CA

24d • $146,540 - $189,640

About The Position

Gilead Sciences is a research-based biopharmaceutical company focused on discovering, developing, and commercializing innovative medicines for unmet medical needs in virology, oncology, and inflammation. The Content Strategy & Development (CSD) department, part of Innovation, Content, & Execution (ICX) within Regulatory Affairs, is responsible for advancing the strategy and creation of high-quality documents to support efficient and successful regulatory submissions. This role is within the Oncology therapeutic area and offers an opportunity to develop expertise in preparing a wide range of documents while working with cross-functional teams to deliver documents on time and per team expectations. Gilead fosters an inclusive and diverse community with strong leaders committed to individual development and growth, supporting work-life balance.

Requirements

• 6+ years of relevant experience with BS/BA
• 4+ years of relevant experience with MA/MAS/MPH/MBA
• 2+ years of relevant experience with PharmD/PhD or equivalent
• The ability to understand the needs of a team and manage their expectations and use various communication styles to work effectively with teams
• The ability to balance integrity and efficiency when managing attention to detail
• Knowledge of regulatory document requirements/guidelines
• Proficiency in the use of Microsoft Office and document management systems
• Relevant experience includes clinical research and development, regulatory affairs, or related industry/academic experience, with direct experience preparing clinical/regulatory documents in a medical writing/clinical submissions environment.

Responsibilities

• Prepare clinical documentation for global regulatory submissions.
• Develop expertise in the preparation of a wide range of documents.
• Work with cross-functional teams (e.g., Regulatory Affairs, Clinical Research, Clinical Operations, Clinical Pharmacology, Patient Safety, and Clinical Data Science) to deliver documents on time and per team expectations.
• Drive document strategy for Medical Writing.
• Author clinical/regulatory documents such as clinical study reports (all phases), protocols and amendments, and investigator brochures according to regulatory requirements and Gilead internal document standards with some input from a more senior writer.
• Work in tandem with a more senior writer on other document types such as integrated clinical summaries, pediatric investigation plans, or regulatory responses.
• Participate in regulatory submission teams, providing guidance for optimal presentation of data to achieve document intent.
• Manage document timeline and resource planning with input from a more senior medical writer.
• Participate in development/improvement of document standards, templates, and processes and other non-medical writing activities.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus
• Discretionary stock-based long-term incentives (eligibility may vary based on role)
• Paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Manager