Medical Writer

Medical Writer

Gilead

London, United Kingdom

Job Overview/Responsibilities:

We have an exciting and unique opportunity for a Medical Writer to join our dynamic team at the Associate or Senior Associate level. You will prepare scientific/regulatory documentation to support global regulatory submissions. You will have the opportunity to develop expertise in the preparation of a wide range of clinical/regulatory documents, particularly at the individual study report level. With the support from a more senior writer, 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 Phase 1 or 2 CSRs and IB updates;
  • Author or assist a more senior writer on more complex documents such as Phase 3 CSRs, PIPs/PIP modifications, or CTD summaries/overviews;
  • Contribute to document timelines and planning for assigned work;
  • Contribute to development/improvement of document standards, templates, and document processes and other non-regulatory medical writing activities.

Requirements:

  • Postgraduate degree or BA/BSc with relevant writing experience (clinical R&D, regulatory affairs, or related industry/academia);
  • Knowledgeable of regulatory document requirements/guidelines. Direct exposure to clinical/regulatory documents, such as a CSRs, IBs, in a medical writing/clinical submissions environment is preferred;
  • Excellent communication skills and attention to detail;
  • Well-developed computer skills including proficiency in MS Office (in particular MS Word [intermediate or advanced level]) and document management systems.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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