CMC Writer

JR United Kingdom; England; Remote; GBP 60,000 - 80,000; Full time

Job summary

A leading life sciences recruiter in the UK seeks an experienced CMC Writer to support regulatory affairs in oncology and biotechnology. This remote position will involve managing Module 3 deliverables, including NDA and MAA submissions, collaborating with various experts to ensure high-quality outcomes.

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 simultaneously.

Responsibilities

• Manage a range of Module 3 deliverables for US and EU filings.
• Lead the writing process for NDA and MAA submissions.
• Coordinate with global experts to ensure data gathering.

Skills

CMC medical writing

Leadership

Communication

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:

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy

Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit. Check our Blog for more information.

Bank or payment details should not be provided when applying for a job. Eurojobs.com is not responsible for any external website content. All applications should be made via the 'Apply now' button.

Created on 26/06/2025 by JR United Kingdom