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Senior Manager, Medical Writing, Protocol Lead - Oncology

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Nov 28, 2023

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Job Details

Senior Manager, Medical Writing, Protocol Lead - Oncology
United States - California - Foster CityUnited States – RemoteUnited States - New Jersey - Parsippany

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. 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’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description



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 Medical Writing department is 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.

The Role:

We have an exciting and unique opportunity for a Senior Medical Writer (Senior Manager) to join our dynamic team. You will have the opportunity to develop expertise in the preparation of a wide range of documents, particularly for protocol development. You will work collaboratively within cross-functional teams (eg, Regulatory Affairs, Clinical Research, Clinical Operations, Clinical Pharmacology, Global Patient Safety, and Clinical Data Science) to lead protocol development for large clinical programs and drive document strategy for Medical Writing. Direct experience in protocol authoring or management is highly preferred.

Key responsibilities include:
  • Lead the development of protocols and amendments for Medical Writing in the Oncology therapeutic area, including development and management of timelines and resource planning, supporting large clinical programs.
  • Independently author clinical/regulatory documents such as protocols and amendments, CSRs (all phases), and IBs according to regulatory requirements and internal Gilead document standards.
  • Author high complexity documents such as integrated CTD summaries/overviews, PIPs/PIP modifications, or regulatory responses with some input from a more senior writer.
  • Oversee contract medical writers on protocols and amendments to ensure the highest quality of medical writing and adherence to Gilead document standards.
  • Collaborate with other lead writers to support a development program from first study through regulatory submissions.
  • May coach, train, and provide guidance to less experienced writers.
  • Participates in development/improvement of document standards, templates, and processes and other non-medical writing activities.


You Will Need:
  • The ability to understand the needs of a team and manage their expectations and to use various communication styles to work effectively with teams.
  • The ability to balance integrity and efficiency when managing attention to detail.
  • In-depth knowledge of industry regulations, regulatory documentation requirements, and Gilead medical writing processes and standards
  • Proficient in the use of Microsoft Office and document management systems
  • Bachelor's degree, or local equivalent, or equivalent experience qualification
  • Relevant experience includes clinical R&D, regulatory affairs, or related industry/academic experience, with direct experience preparing clinical/regulatory documents in a medical writing/clinical submissions environment.


Why Work at Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. 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's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Our Core Values and Leadership Commitments:
  • Integrity (always doing the right thing)
  • Teamwork (collaborating in good faith)
  • Excellence (working at a high level of commitment and capability)
  • Accountability (taking personal responsibility)
  • Inclusion (encouraging diversity)


The salary range for this position is: $160,820.00 - $208,120.00. 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

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

For Current Gilead Employees and Contractors:


Please log onto your Internal Career Site to apply for this job.






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Company

Gilead Sciences is a biopharmaceutical company that discovers, develops, and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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