Sr Director, Medical Writing

Gilead Sciences International, Ltd.; England; On-site; GBP 140,000 - 210,000; Full time

Job summary

Gilead Sciences International, Ltd. is seeking a Senior Director to lead medical writing strategy and development for complex regulatory submissions. You will guide cross-functional teams across regulatory, clinical, and data science to deliver high-quality documents on time and in compliance.

You will oversee TA- or portfolio-level activities, mentor leaders, and drive initiatives that raise standards for document creation and submission integrity across the organization.

Qualifications

• Experience leading large cross-functional work, projects, and teams in life sciences.
• Expertise in regulatory medical writing for complex submissions.
• Strong strategic planning, governance, and oversight capabilities.

Responsibilities

• Leads and manages a team of direct reports and may oversee external contractors.
• Leads at the TA or portfolio level, coordinating complex submissions across TAs.
• Oversees all deliverables and activities performed by the team.
• Develops cross-functional training programs and drives process improvement on document standards.
• Represents the CSD function in cross-functional initiatives and special projects.
• Acts as subject matter expert for clinical/regulatory documents for high-impact projects.

Skills

Medical writing

Regulatory submissions

Leadership

Cross-functional collaboration

Education

BA/BS or higher in life sciences

Job description

Description

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need including virology, oncology, and inflammation. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world.

Gilead Regulatory Affairs is a committed and proud team of highly skilled professionals dedicated to helping deliver therapies in the most efficient and effective way to patients with unmet medical need around the world. We bring our passion for science, discovery, and innovative strategic thinking into everything we do. The Content Strategy & Development (CSD) department is part of Innovation, Content, & Execution (ICX) within Regulatory Affairs, and advances the strategy and creation of high-quality documents to support efficient and successful regulatory submissions.

We are an inclusive and diverse community, supported by strong leaders who are committed to providing individual development and growth opportunities while achieving our mission. Our collaborative and supportive structure help support work-life balance.

Job Overview/Responsibilities:

We have an exciting and unique opportunity for a medical writer and leader to join our dynamic team at the Senior Director level. You are a subject matter expert, providing specialist content strategy and development expertise for regulatory guidance/industry standards with a specific focus on business-critical and high-impact projects. You will lead at the therapeutic area (TA) or portfolio level, overseeing strategic planning and drafting of the most complex submissions and/or other clinical, regulatory, or business content. You will work with cross-functional teams (eg, Regulatory Affairs, Clinical Research, Clinical Operations, Clinical Pharmacology, Patient Safety, and Clinical Data Science) to deliver documents on time and per team expectations and drive document strategy.

Key Responsibilities include:

• Leads and manages a team of direct reports and may manage external contractors and/or other people leaders. Hires, develops, and retains diverse top talent in the team. Ensures the team and the assigned work comply with established practices, policies, and processes and any regulatory or other requirements.
• Leads at the TA or portfolio level, overseeing strategic planning and drafting of the most complex submissions across TAs. Leads cross-functional teams to organize information and identify key messaging and supporting data to achieve submission objectives.
• Oversees, guides, and directs all deliverables and activities performed by the assigned team.
• Communicates changes to regulatory requirements and assists with the development of relevant cross-functional training programs, alongside process improvement initiatives on document standards, processes, and template development.
• Leads other special projects and represents the CSD function in other cross-functional initiatives.
• Acts as the subject matter expert, providing specialist medical writing expertise for clinical/regulatory documents for business-critical and high impact projects.

Basic Qualifications:

BA/BS or advanced degree in life sciences or related field with significant experience leading or co-leading large-scale, highly complex cross-functional work, projects, and teams in life sciences, including leading short- and long-range strategic planning, governance, and oversight.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.