Senior Manager, Medical Writer, Protocol Lead
Senior Manager, Medical Writer, Protocol Lead
United States - California - Foster CityUnited States - New Jersey - Morris PlainsUnited States - Washington - Seattle
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. Gileads 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 companys five core values. Thats 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
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.
About Gilead Regulatory Affairs:
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 part of Regulatory Documentation and Submissions (RDS) 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.
We have an exciting and unique opportunity for a Senior Medical Writer (Senior Manager) to join our dynamic team. You will prepare clinical documentation to support global regulatory submissions. 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, Virology, or Inflammation therapeutic areas, 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 system
- 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.
For jobs in the United States:
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 email@example.com for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
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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:
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