Senior Regulatory Writer

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Senior Regulatory Writer, United Kingdom

Client:

Meet Life Sciences

Location:

Job Category:

Other

EU work permit required:

Yes

Job Views:

6

Posted:

06.04.2025

Expiry Date:

21.05.2025

Job Description:

Job Title: Senior Regulatory and Medical Writer

Overview: The Senior Regulatory and Medical Writer provides medical writing support across regulatory affairs, clinical operations, and medical affairs teams on various projects. The role involves collaboration with internal teams and direct client engagement for standalone medical writing projects.

Specific Responsibilities:

1. Prepare clinical documents, including study protocols, amendments, clinical study reports, and investigator brochures/updates.
2. Develop EU and US regulatory documents, such as Common Technical Document clinical summaries and overviews, scientific advice briefing documents, pediatric investigation/study plans, PRIME/Breakthrough Therapy applications, and orphan drug designation applications.
3. Manage projects by creating and maintaining timelines and liaising with clients while demonstrating strong time management skills.
4. Oversee the document review process, resolve unclear/conflicting comments, and lead comment resolution meetings with clients.
5. Organize quality control (QC) reviews of documents and address feedback.
6. Provide editorial support and formatting for documents authored by regulatory affairs and clinical operations teams.
7. Conduct peer reviews of documents from internal teams.
8. Offer guidance and training to junior medical writers and other team members.
9. Assist in the development, implementation, and maintenance of medical writing process improvements, including style guides, templates, toolbars, and proofreading software, and provide relevant training.
10. Ensure that regulatory filings for assigned projects are maintained.
11. Support ongoing projects and business activities, including mentoring team members.
12. Stay updated on regulatory and clinical developments.

General Responsibilities:

1. Adhere to departmental guidelines and best practices.
2. Contribute to the continuous improvement of medical writing standards and processes.
3. Collaborate effectively with cross-functional teams and external stakeholders.

Company Values: Supportive, Strategic Thinkers and Problem Solvers, Respected, Pioneering, and Inspiring.

Qualifications & Experience:

1. Minimum of a B.Sc. in a life sciences subject (a higher degree is advantageous).
2. Approximately 3-5 years of relevant experience in a consultancy or equivalent environment.
3. Excellent written and verbal communication skills with the ability to articulate ideas clearly and engage diverse audiences.
4. Strong proficiency in Microsoft Office, particularly Word.

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Created on 06/04/2025 by JR United Kingdom