Senior Manager, Content Strategy & Development – Protocol Lead

Gilead Sciences

Senior Manager developing medical writing protocols for biopharmaceutical company Gilead. Leading cross-functional teams and ensuring high-quality regulatory submissions in Oncology.

Posted 4/23/2026full-timeFoster City • California, New Jersey • 🇺🇸 United StatesSenior💰 $143,225 - $185,350 per yearWebsite

About the role

Key responsibilities & impact

Develop expertise in the preparation of a wide range of documents, with a focus on protocol development
Work collaboratively within cross-functional teams (eg, Regulatory Affairs, Clinical Development, Patient Safety, Biostatistics, Clinical Pharmacology, Clinical Operations) to lead protocol development for large clinical programs
Drive document strategy
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

Requirements

What you’ll need

Bachelor's Degree and Eight Years’ Experience OR Masters' Degree and Six Years’ Experience OR Ph.D.
PharmD/PhD with 4+ years’ relevant experience preferred
MA/MS/MPH/MBA with 6+ years’ relevant experience preferred
BA/BS with 8+ years’ relevant experience preferred
Significant content strategy and development, regulatory, quality, clinical R&D, or related experience supporting medicinal products
Significant experience in the biopharma industry is strongly preferred
Experience authoring a broad range of regulatory, scientific, medical and other business content across multiple stages of drug development
Knowledge of AI and other emerging technologies to complete medical writing or related deliverables is preferred
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

Benefits

Comp & perks

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location
This position may also be eligible for a discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

protocol developmentmedical writingregulatory requirementsclinical R&Dcontent strategydocument standardsintegrated CTD summariesregulatory responsesamendmentsICFs

Soft Skills

collaborationleadershipcommunicationorganizational skillsattention to detailindependencestrategic thinkingproblem-solvingquality assuranceteamwork

Certifications

Bachelor's DegreeMaster's DegreePh.D.PharmDMAMSMPHMBA