CMC Writer

Proclinical Staffing; England; Remote; GBP 75,000 - 100,000; Full time

Job summary

Proclinical Staffing is seeking a mid-senior level Director of Regulatory Affairs to manage critical regulatory strategies in oncology and biotechnology. This remote position requires a skilled CMC Writer to oversee Module 3 documentation and collaborate with global experts. Join a leading life sciences recruiter and make a significant impact while enjoying the benefits of remote work.

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 the writing process for NDA and MAA submissions.
• Coordinate with global experts and gather necessary data.

Skills

CMC medical writing

Leadership in NDA submissions

Strong communication skills

Job description

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from Proclinical Staffing

Director Regulatory Affairs Contract - UK and EU

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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Science

• Industries

  Professional Services

Referrals increase your chances of interviewing at Proclinical Staffing by 2x

Greater London, England, United Kingdom 1 week ago

Staines-Upon-Thames, England, United Kingdom 1 week ago

Birmingham, England, United Kingdom 1 week ago

Coventry, England, United Kingdom 1 week ago

Southampton, England, United Kingdom 1 week ago

Leeds, England, United Kingdom 1 week ago

Greater London, England, United Kingdom 4 days ago

London, England, United Kingdom 22 hours ago

Manchester Area, United Kingdom 3 days ago

Freelance Content Writer (Remote, Contract) – London

London, England, United Kingdom 3 weeks ago

Manchester Area, United Kingdom 3 days ago

North West, England, United Kingdom 2 weeks ago

Freelance Content Writer (Remote, Contract) – Birmingham

Birmingham, England, United Kingdom 3 weeks ago

St Albans, England, United Kingdom 4 days ago

Freelance English Content Writer - AI Trainer

London, England, United Kingdom 2 weeks ago

Southampton, England, United Kingdom 4 days ago

London, England, United Kingdom 4 days ago

Technical Author (multiple roles and seniority levels)

London, England, United Kingdom 1 week ago

Manchester, England, United Kingdom 4 days ago

Coventry, England, United Kingdom 4 days ago

Stoke-On-Trent, England, United Kingdom 4 days ago

Freelance English Content Writer - AI Trainer

Manchester, England, United Kingdom 2 weeks ago

London, England, United Kingdom 2 months ago

Freelance English Content Writer - AI Trainer

Birmingham, England, United Kingdom 2 weeks ago

Greater London, England, United Kingdom 1 week ago

Stoke-On-Trent, England, United Kingdom 4 days ago

London, England, United Kingdom 4 weeks ago

London, England, United Kingdom 1 week ago

London, England, United Kingdom 1 week ago

London, England, United Kingdom 5 months ago

Birmingham, England, United Kingdom 4 days ago

Staines-Upon-Thames, England, United Kingdom 4 days ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.