Senior Manager, Medical Writing, Oncology

Gilead; United States; Remote; USD 80,000 - 140,000; Full time

Job summary

An established industry player is seeking a Senior Manager for Medical Writing in Oncology. This pivotal role involves authoring complex regulatory documents and leading cross-functional teams to ensure successful submissions. The ideal candidate will have extensive experience in medical writing, particularly within the biopharma sector, and will play a crucial role in advancing product strategies. Join a dynamic team committed to making a significant impact in the healthcare landscape and be part of a mission that prioritizes innovation and collaboration. This is an exciting opportunity to contribute to life-changing therapies and work in a supportive environment that values growth and development.

Qualifications

• 4+ years of relevant experience in medical writing or related fields.
• Experience authoring regulatory documents across drug development stages.

Responsibilities

• Author a wide range of complex 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

Interpersonal Skills

Education

PharmD/PhD

MA/MS/MPH/MBA

BA/BS

Tools

Microsoft Office Suite

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.

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.
• Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.

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.

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.