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Gilead Sciences, Inc. Senior Medical Writer in Dublin, Ireland

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Job Description

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.

Job Overview/Responsibilities:

We have an exciting and unique opportunity for a Medical Writer to join our dynamic team at the Senior 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 and submission 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:

  • 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.

  • May serve as a filing lead for a small to medium regulatory submission, with responsibilities including development and management of document timelines and resource planning for assigned projects.

  • May serve as lead medical writer and department representative on a medium to large development program.

  • Participates in multiple cross functional teams (e.g., regulatory submission teams or regulatory project teams) providing advice/guidance to the team on regulatory document requirements or on optimal presentation of data for achievement of document objectives.

  • May coach, train, and provide guidance to less experienced writers.

  • May manage or supervise direct reports and contract medical writers to ensure the highest quality of medical writing and adherence to Gilead document standards.

  • Participates in development/improvement of document standards, templates, and processes and other non-medical writing activities.

Requirements:

  • Bachelor’s degree or higher with significant 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.

About 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.

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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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