SENIOR / PRINCIPAL REGULATORY MEDICAL WRITER REMOTE

Posting Date: 15.02.2024

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We are looking for a Senior / Principal Regulatory Medical Writer to join our client’s growing team on permanent basis. This role is with a global CRO and can be based remotely from the UK and select EU countries.

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This role will appeal to a well-rounded Medical Writer who is willing to roll up their sleeves and take the lead on projects, gaining valuable experience along the way. Depending on experience there will be variety of projects to work on in early and late-stage development.

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This is a great opportunity to join a diverse team that is committed to excellence, innovation, and collaboration while contributing to cutting-edge clinical research projects. This team prides itself on having solid processes, strong leadership and an environment encouraging creative problem solving and decision making. Our client offers a competitive salary including a bonus and a comprehensive benefits package. This is a home-based position with a level of flexibility on start and finish times which makes it ideal for someone with a family.

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As a Sr / Principal Medical Writer, you will pay a pivotal role in translating complex scientific and clinical data into a well-structured, accurate and compliant documents. In this role you will collaborate closely with cross-functional tams to create high-quality documents and support successful submissions to health authorities. Your expertise and deep understanding of the drug development process will be essential in contributing to the success of our client’s clinical research initiatives.

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Responsibilities:

• Prepares regulatory documents with minimum guidance in a variety of therapeutic areas and development stages – CSRs, CSPs, IBs, CTD summaries etc. Ensuring adherence to regulatory requirements.

• Develops and manages work plans for individual and multiple document delivery, including all necessary timelines, tasks and subtasks, roles, and responsibilities to enable work efficiency and on time delivery.

• Leads cross-functional teams to draft and develop agreed-upon medical content. Coordinates kick-off meetings with all contributors and cross-functional representatives, ensuring clear communication between members.

• Under strict timelines, organises document review activities as well as consensus meetings, QA, and document finalization.

• Participates in the coaching and training of junior team members.

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Knowledge and experience needed:

• Bachelor’s degree or an advanced degree level in a scientific field (PharmD, PhD, or MD).

• 5+ years of experience with regulatory medical writing.

• Experience leading projects and authoring clinical documents (CSPs, CSRs, IBs, narratives, safety documents etc.) and/or documents supporting regulatory affairs (CTD summary and overview documents for MAAs, INDAs, NDAs, PiPs etc.).

• Scientific background and ability to interpret and communicate complex scientific concepts in a variety of therapeutic areas.

• Excellent understanding of the drug development process and the regulatory requirements and guidelines in the US and the EU.  

• Strong grammatical, proofreading, and editorial skills.

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If you are looking for your next career step in Medical Writing, then this may be the opportunity you have been waiting for. Get in touch for more information or click on the apply button to send us your CV or register your interest.

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