Sr Director, Medical Writing

2060 Gilead Sciences International, Ltd.; Cambridge; On-site; GBP 90,000 - 130,000; Full time

Job summary

Gilead Sciences, Inc. is seeking a Senior Director level medical writer to lead regulatory content strategy and development for complex submissions across therapeutic areas. You will lead cross-functional teams to deliver high-impact documents on time and mentor writers and contractors.

This role requires strategic planning, deep regulatory knowledge, and the ability to drive standards and training within the Content Strategy & Development function.

Qualifications

• Experience leading large-scale cross-functional work in life sciences.
• Proven ability to manage complex regulatory submissions across TA.
• Strong communication and mentoring skills within a regulatory context.

Responsibilities

• Leads and manages a team of direct reports and may manage external contractors.
• Oversees strategic planning and drafting of complex regulatory submissions.
• Collaborates with Regulatory Affairs, Clinical Research, and cross-functional teams to deliver high-quality documents on time.

Skills

Medical writing leadership

Regulatory submissions

Cross-functional leadership

Therapeutic area strategy

People leadership

Education

BA/BS or advanced degree in life sciences

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

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

• 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.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.