
Senior Manager, Medical Writing
Welcome to Gilead Sciences, a leading biopharmaceutical company dedicated to developing innovative treatments for life-threatening diseases. We are currently seeking a highly skilled Senior Manager, Medical Writing to join our team and contribute to the development and communication of our cutting-edge therapies.In this role, you will lead a team of medical writers and collaborate with cross-functional teams to produce high-quality clinical documents that support the development, registration, and post-approval activities of our products. You will also be responsible for overseeing the strategic planning and execution of writing activities, ensuring adherence to industry regulations and guidelines.To thrive in this position, you must possess a Bachelor's degree in a scientific discipline and have a minimum of 8 years of experience in medical writing within the biopharmaceutical industry. In addition, you must have strong leadership skills, excellent communication and project management abilities, and a deep understanding of regulatory requirements.If you are passionate about making a meaningful impact on patients' lives and have a strong background in medical writing, we encourage you to apply for this exciting opportunity to join our dynamic team at Gilead Sciences.
- Lead and manage a team of medical writers to produce high-quality clinical documents that support the development, registration, and post-approval activities of Gilead's products.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and pharmacovigilance, to ensure timely and accurate completion of clinical documents.
- Develop and implement strategic plans for medical writing activities, including timelines and resource allocation, to support product development and registration.
- Ensure adherence to industry regulations and guidelines, as well as internal company procedures and standards, in all medical writing activities.
- Review and edit clinical documents and provide guidance and feedback to team members to ensure accuracy, consistency, and compliance with regulatory requirements.
- Keep abreast of new developments and changes in regulations and guidelines related to medical writing, and incorporate them into the team's processes and procedures.
- Mentor and train junior medical writers to develop their skills and knowledge in medical writing and Gilead's therapeutic areas.
- Collaborate with external vendors, such as contract research organizations (CROs) and medical writers, to ensure timely and high-quality delivery of clinical documents.
- Represent the medical writing team in cross-functional meetings and provide updates on the progress of medical writing activities.
- Contribute to the development of templates, style guides, and standard operating procedures (SOPs) for medical writing to ensure consistency and quality across all clinical documents.
- Manage budget and resources for medical writing projects, including outsourcing and vendor management.
- Uphold Gilead's values and culture by demonstrating ethical behavior, promoting diversity and inclusion, and fostering a collaborative and respectful work environment.
- Continuously seek opportunities for process improvement and implement new tools and technologies to enhance the efficiency and effectiveness of medical writing activities.
- Represent Gilead at scientific conferences and contribute to the dissemination of key study results through presentations and publications.
- Support regulatory submissions and health authority interactions, as needed,
Advanced Degree In Life Sciences: A Senior Manager, Medical Writing At Gilead Sciences Should Possess A Minimum Of A Master's Degree In A Relevant Field Such As Biology, Pharmacology, Or Biochemistry. A Phd Or Md Degree Would Be Preferred.
Extensive Experience In Medical Writing: Candidates Should Have A Minimum Of 5 Years Of Experience In Medical Writing, Preferably In The Pharmaceutical Or Biotechnology Industry. This Experience Should Include Writing And Reviewing Clinical Study Reports, Protocols, And Regulatory Documents.
Strong Knowledge Of Regulatory Requirements: The Ideal Candidate Should Have A Thorough Understanding Of Fda And Ich Guidelines And Regulations Pertaining To Clinical Study Documentation And Submissions.
Excellent Project Management Skills: As A Senior Manager, Medical Writing At Gilead Sciences, The Candidate Will Be Responsible For Managing A Team Of Medical Writers And Ensuring Timely Completion Of Writing Projects. Therefore, Strong Project Management Skills And The Ability To Prioritize Tasks Are Essential Qualifications For This Role.
Leadership And Communication Skills: The Candidate Should Possess Excellent Leadership Skills And The Ability To Effectively Communicate And Collaborate With Cross-Functional Teams. This Includes Working Closely With Clinical, Regulatory, And Safety Teams To Ensure Accurate And Timely Completion Of Documents.
Strategic Planning
Data Analysis
Communication
Time Management
Team Management
Leadership
Quality Control
Scientific writing
Problem-Solving
Cross-Functional Collaboration
Regulatory Knowledge
Project Oversight
Communication
Conflict Resolution
Leadership
Time management
creativity
Organization
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Senior Manager, Medical Writing is $120,000-$160,000 per year. This can vary depending on factors such as location, experience, and company size. Some senior medical writing managers may also receive bonuses or other forms of compensation in addition to their base salary.
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Gilead Sciences, Inc., is an American biotechnology company that researches, develops and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

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