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Proclinical is seeking a skilled CMC Writer to join our client's team, focusing on regulatory affairs within the oncology and biotechnology sectors. This role involves managing Module 3 writing projects and updates for both US and EU submissions. You will work remotely, collaborating with subject matter experts and contract manufacturing organizations to ensure timely and high-quality document completion.
Responsibilities:
- Manage a range of Module 3 deliverables, including new sections and updates for simultaneous US and EU filings.
- Lead the writing process for NDA and MAA submissions, as well as follow-on variations and supplements.
- Coordinate with global experts and gather necessary data from CMOs.
- Ensure documents are polished and ready for agency submission.
Key Skills and Requirements:
- Extensive experience in CMC medical writing for small or large molecules.
- Proven leadership in NDA and MAA submissions.
- Ability to work independently and manage multiple projects simultaneously.
- Strong communication skills to effectively collaborate with diverse teams.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
Apply Now:
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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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