CMC Writer

Proclinical is currently seeking a Chemistry, Manufacturing, and Controls Writer for a pharmaceutical company located in Pennsylvania. Successful candidate will be responsible for writing, reviewing, and editing cGMP documents, product specifications, Standard Operating Procedures, and CMC sections of regulatory documents.

Job Responsibilities

• Researching and collaborating with subject matter experts to write and edit Standard Operating Procedures, Specifications, batch documentation and other manufacturing related controlled technical documents.
• Assisting with technical publishing. Supporting in developing documentation for instructional training, descriptive, reference and/or informational purposes.
• Coordinating the review, approval and revision of procedures, specifications and forms.
• Working with initiators to rewrite, clarify or reconstruct controlled documents.
• Supporting Technical Operations team to ensure alignment and established priorities to meet and exceed site and corporate goals.
• Working collaboratively and transparently with Quality Assurance and Regulatory Affairs to ensure high quality level of cGMP produced documentation.

Skills and Requirements

• BS in Chemistry, Pharmaceutical Sciences, Regulatory Affairs or other relevant field.
• 3-5 years of experience in authoring CMC sections of regulatory filings.
• Experience working closely with other departments such as Process Chemistry, Analytical, Large Molecule Development, and/or Regulatory Affairs.
• Demonstrate competency in clear and concise technical writing ability.
• Understand CMC manufacturing and control documentation requirements for both small and large molecule manufactured products.
• Demonstrated ability to organize and prioritize a large and varied workload.
• Strong communication skills, team player, and proven negotiation skills.
• Good decision making with strong judgment through collaboration and consideration of others point-of-view.
• Sound technical knowledge of process chemistry, analytical methods, and drug product.
• Must be well organized, flexible and able to communicate effectively within CMC functions and Regulatory affairs.
• Must be knowledgeable and experienced in biotech manufacturing related industry.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 646-878-6308 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

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

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