United Kingdom - Uxbridge
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
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 Medical Writer to join our dynamic team at the Manager level. 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 at the individual study report level. You will work collaboratively within cross-functional teams (eg, Regulatory, Clinical Research, Pharmacovigilance, Biometrics, and Virology) to deliver documents on time and per team expectations.
Key responsibilities include:
- Author clinical/regulatory documents such as protocols and amendments, CSRs (all phases), and IBs according to regulatory requirements and internal Gilead document standards with limited oversight from a more senior writer.
- Author or assist a more senior medical writer on more complex documents such as integrated CTD summaries/overviews, PIPs/PIP modifications, or regulatory responses.
- Represent Medical Writing on cross-functional project teams with input or supervision of a more senior medical writer.
- May participate in regulatory submission teams, providing advice/guidance to the team on regulatory document requirements or on optimal presentation of data for achievement of document objectives.
- May lead document timeline/resource planning with input from a more senior medical writer.
- Contribute to development/improvement of document standards, templates, and processes and other non-medical writing activities.
- Bachelors degree or higher with 3+ years of relevant writing experience.
- Knowledgeable of regulatory document requirements/guidelines.
- Well-developed computer skills including proficiency in MS Office (in particular MS Word [intermediate or advanced level]) and document management systems.
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.
Gilead Core Values:
- 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)
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-Kingdom---Uxbridge/Medical-Writer_R0018404
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