Senior Manager, Content Strategy & Development (Medical Writing) - Protocol Lead

Gilead Sciences • Foster City, CA

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About The Position

Gilead is a biopharmaceutical company dedicated to creating a healthier world by tackling diseases such as HIV, viral hepatitis, COVID-19, and cancer for over 35 years. The company focuses on developing therapies and ensuring global access, emphasizing collaboration, determination, and making a difference. Employees are considered the greatest asset, and People Leaders are crucial for fostering an inclusive, developed, and empowered employee experience. This role is within Gilead Regulatory Affairs, specifically in the Content Strategy & Development (CSD) department, which is part of Innovation, Content, & Execution (ICX). CSD is responsible for advancing the strategy and creation of high-quality documents to support efficient and successful regulatory submissions. The department is described as an inclusive and diverse community with strong leaders committed to individual development, growth, and work-life balance. This Senior Manager position offers a unique opportunity for a regulatory medical writer to join the dynamic CSD team, focusing on protocol development for large clinical programs in the Oncology therapeutic area. The role involves developing expertise in a wide range of documents and collaborating with various cross-functional teams.

Requirements

• Bachelor's Degree and Eight Years’ Experience OR Masters' Degree and Six Years’ Experience OR Ph.D.
• Significant content strategy and development, regulatory, quality, clinical R&D, or related experience supporting medicinal products.
• Experience authoring a broad range of regulatory, scientific, medical and other business content across multiple stages of drug development.
• Knowledgeable of regulatory document requirements/guidelines with direct experience in a wide variety of regulatory document types.
• Well-developed computer skills including proficiency in Word, Adobe, Excel, and the Regulatory Document Management System.

Nice To Haves

• PharmD/PhD with 4+ years’ relevant experience.
• MA/MS/MPH/MBA 6+ years’ relevant experience.
• BA/BS with 8+ years’ relevant experience.
• Significant experience in the biopharma industry is strongly preferred.
• Direct experience in protocol authoring or management is highly preferred.
• Knowledge of AI and other emerging technologies to complete medical writing or related deliverables is preferred.

Responsibilities

• Lead the development of protocols and amendments for CSD (Medical Writing) in the Oncology therapeutic area, including development and management of timelines and resource planning, supporting large clinical programs.
• Oversee internal and external medical writers on protocols and amendments to ensure the highest quality of medical writing and adherence to Gilead content and quality standards.
• Independently author a wide variety of clinical/regulatory documents such as protocols and amendments, ICFs, CSRs (all phases), and IBs according to regulatory requirements and internal Gilead document standards.
• Author high complexity documents such as integrated CTD summaries/overviews, PSPs, PIPs/PIP modifications, or regulatory responses with some input from a more senior CSD team member.
• Participate in development/improvement of document standards, templates, and processes and other non-medical writing activities.
• Effectively communicate with a variety of teams and individuals.
• May coach, train, and provide mentoring and guidance to less experienced writers.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees