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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Consultant / Specialist, Publishing & Submissions, CMC

Location: United States

Proclinical is seeking a remote CMC Regulatory Technical Writer for a global biopharmaceutical company.

Must be eligible to work in the US.

Job Responsibilities:

Author the CMC sections of regulatory documents (e.g., IND/IMPD, BLA/MAA, health authority questions, briefing documents) to support the timely submissions of investigational and marketing applications of primarily biologics
Contribute to global regulatory writing strategy for CMC content and drive CMC content requirements on assigned projects.
Interpret and summarize complex data in close collaboration with technical line SMEs
Develop timelines, prepare and manage the review and approval of submission ready documents.
Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations
Critical review of submission documents to ensure messaging is clear and consistent within and across documents
Well versed in formatting using Microsoft Word and authoring tools, and perform final copyediting checks of CMC documents

Skills and Requirements:

Experience in regulatory submissions, supporting the preparation of Module 3 components of a submission, related Quality/CMC documents and components, and regulatory briefing documents
Critical evaluation of analytical data with knowledge of fundamental principles of biochemistry, bioprocess, and/or pharmaceutical development
Good writing skills for technical content and scrupulous attention to detail
Excellent verbal communication skills for leading meetings and constructive remote interactions
Negotiate the delivery of approved technical documents in accordance with project timelines
Work well in team setting on a fast-paced business critical project
Able to work independently, strong ability to prioritize workload
Knowledge and experience using regulatory information management systems
Scientific background (B.S or M.S.) to understand pharmaceutical drug development concepts, CMC regulatory concepts, and create documentation based on these concepts
Comprehensive understanding of regulations and quality guidelines to enhance probability of regulatory success and compliance
Demonstrated excellence in project management

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at +(1) 267-846-2026 or j.cerchio@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-JC8

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