Senior Manager, Medical Writing, Oncology

Gilead Sciences, Inc.; Foster City (CA); On-site; USD 154,000 - 200,000; Full time

Job summary

An established industry player is seeking a Senior Manager in Medical Writing specializing in Oncology. This pivotal role involves authoring complex regulatory documents, leading cross-functional teams, and ensuring compliance with industry standards. You will have the opportunity to influence product strategies and mentor junior writers, all while working in a collaborative environment that values innovation and excellence. If you are passionate about making a difference in the biopharma sector and have a strong background in medical writing, this role could be your next career milestone. Join a team that is dedicated to advancing healthcare solutions and improving patient outcomes.

Benefits

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Medical insurance

Dental insurance

Vision insurance

Life insurance

Qualifications

• PharmD/PhD with 4+ years or MA/MS/MPH/MBA with 6+ years of relevant experience.
• Strong experience in medical writing and regulatory documentation.

Responsibilities

• Author a wide variety of regulatory documents independently.
• Lead review and planning processes for multiple products or projects.
• Coach and train less experienced Medical Writing colleagues.

Skills

Medical Writing

Regulatory Documentation

Project Management

Analytical Thinking

Communication Skills

Team Collaboration

Oncology Knowledge

Microsoft Office Suite

Education

PharmD/PhD

MA/MS/MPH/MBA

BA/BS

Tools

Microsoft Office

Job description

Senior Manager, Medical Writing, Oncology

Locations: United States - California - Foster City, United States – Remote, United States - New Jersey - Parsippany

Time Type: Full time

Posted On: Vor 13 Tagen

Job Requisition ID: R0043103

Job Description

Medical Writing acts as a strategic partner across drug discovery, development, and commercial teams. Medical Writing participates in cross-functional drug discovery, development and commercial product lifecycle management and contributes strategic, expert input into scientific and regulatory content that is used for a variety of purposes, including critical regulatory submissions. Medical Writing collaborates cross-functionally to advance Gilead's product strategies and ensure successful licensure and maintenance of licensure of Gilead's medicinal products and proprietary methodologies and technologies across Gilead therapeutic areas (TAs) and in all markets around the world.

We have an exciting and unique opportunity for a senior level medical writer (Senior Manager, Medical Writing, Oncology) to join our dynamic team. You will author a wide range of regulatory documents independently, including documents of high complexity. You will lead review and planning processes for multiple products or projects. You will represent Medical Writing on relevant product, project, and/or regulatory submissions teams; providing specialist guidance on the optimal content and presentation of content to achieve product/project objectives. You may also represent Medical Writing on other cross-functional initiatives. You will plan and have oversight for assigned medical writing deliverables and may serve as the filing lead for small to medium regulatory submissions. You will participate in process improvements, new standards, and updating document templates. You may coach, train, and provide guidance to less experienced Medical Writing colleagues. You may manage or supervise direct reports and contractors to ensure highest quality of medical writing and adherence to Gilead documents standards.

Example Responsibilities:

• Authors a wide variety of documents of all types and complexities, such as clinical study reports (CSRs all phases), investigator’s brochures, CTD summaries/overviews, PIPs/PIP modifications, and regulatory responses.
• May represent Medical Writing in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for optimal presentation of data to achieve document intent.
• Plans and oversees assigned medical writing deliverables with responsibilities including development and management of document timelines and resource planning for assigned projects.
• May serve as the filing lead for small to medium regulatory submissions.
• May serve as lead medical writer and department representative across development programs.
• Participates in development/improvement of document standards, templates, and processes and other non-medical writing activities.
• May also participate in other special projects and/or represent Medical Writing in other cross-functional initiatives.
• Where applicable, oversees the work of external contractors supporting deliverables and other activities.
• May coach, train, and provide guidance to less experienced Medical Writing colleagues.
• May manage one or more direct reports.

Requirements:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

U.S. Education & Experience

• PharmD/PhD with 4+ years’ relevant experience.
• MA/MS/MPH/MBA 6+ years’ relevant experience.
• BA/BS with 8+ years’ relevant experience.
• Significant medical writing, 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, and/or medical documentation across multiple stages of drug development.
• Experience working with one or more Gilead TAs and varying stages of drug development is strongly preferred.

Rest of World Education & Experience

BA/BS or advanced degree in life sciences or related field with significant medical writing experience in the biopharma industry.

Knowledge & Other Requirements

• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Recognized as a SME in a broad range of regulatory documentation and a resource for specialist advice and guidance.
• In-depth knowledge of relevant health authorities, including system, processes and requirements.
• In-depth knowledge of regulatory document requirements and guidelines relevant to assigned products, projects, and markets, as evidenced by effectiveness and successes authoring a broad range of regulatory documentation.
• Able to advise cross-functional partners on standard/routine regulatory documentation and processes to meet business goals and objectives.
• Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
• Ability to lead and influence programs, projects and/or initiatives.
• Strong interpersonal skills and understanding of team dynamics.
• Proven ability to work successfully in a team-oriented, highly matrixed environment.
• Capability to attend evening meetings as needed to support ROW submissions.
• Significant oncology therapeutic area experience is strongly preferred.
• When needed, ability to travel.

The salary range for this position is: $154,020.00 - $199,320.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit: Gilead Benefits

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.