CMC Writer

Proclinical Group; London; Remote; GBP 50,000 - 80,000; Full time

Job summary

A leading life sciences recruiter is seeking a skilled CMC Writer to join a remote team, managing Module 3 projects for regulatory submissions in oncology and biotechnology. This position demands collaboration with experts to ensure timely and quality document deliverables, providing a significant impact in a dynamic environment.

Qualifications

• 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.

Responsibilities

• Manage Module 3 deliverables for US and EU filings.
• Lead writing for NDA and MAA submissions.
• Coordinate with global experts and CMOs.

Skills

CMC medical writing

Leadership in NDA submissions

Strong communication skills

Project management

Job description

Work from anywhere and shape powerful strategies that drive results! Enjoy the freedom of remote work while making a global impact.

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 [e-mail].

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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