CMC Writer

Proclinical Staffing; United States; Remote; USD 28,000 - 213,000; Full time

Job summary

Proclinical Staffing is seeking a skilled CMC Writer for a 6-month contract role, working flexibly up to 24 hours per week. This remote position primarily involves crafting Module 3 content for regulatory submissions in the US and EU, requiring expertise in CMC writing and regulatory compliance.

Qualifications

• Skilled in CMC writing for both small- and large-molecule products.
• Experience in regulatory submissions necessary.
• Independence and quick integration into projects are essential.

Responsibilities

• Develop and manage Module 3 content for regulatory submissions.
• Collaborate with subject-matter experts and organizations.
• Ensure compliance with regulatory standards.

Skills

Proficiency in CMC writing

Experience leading NDA and MAA submissions

Strong coordination skills

Ability to work independently

Job description

Are you a dedicated individual looking to put your expertise to work fully flexibly in a remote position?

Proclinical is seeking a skilled CMC Writer for a 6-month contract role, working remotely up to 24 hours per week.

Primary Responsibilities:

The successful candidate will focus on crafting comprehensive Module 3 content for regulatory submissions in the US and EU. Your expertise will be crucial in preparing new sections and updates for these filings.

Skills & Requirements:

• Proficiency in CMC writing for both small- and large-molecule products.
• Experience leading NDA and MAA submissions, including variations and supplements.
• Strong coordination skills with global experts and external partners.
• Ability to work independently and integrate quickly into projects.

The CMC Writer's responsibilities will be:

• Develop and manage Module 3 content for regulatory submissions.
• Collaborate with subject-matter experts and contract manufacturing organizations.
• Ensure all documentation meets regulatory standards and deadlines.
• Provide clear and precise technical writing for complex data.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at [e-mail]

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

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