CMC Manager

Proclinical is currently seeking a CMC Writer for an American pharmaceutical company based out of Delaware. Successful candidate will be primarily responsible for writing, reviewing, and editing cGMP manufacturing documents, product specifications, Standard Operating Procedures, engineering related documents, and CMC sections of regulatory documents

Job Responsibilities

• Writing and editing CMC sections of Regulatory documents that are submitted to Regulatory Agencies worldwide.
• Researching and collaborating with subject matter experts to write and edit Standard Operating Procedures, Specifications, batch documentation and other manufacturing documents.
• Helping from time to time with technical publishing.
• Working closely with the Technical Operations leadership 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.
• Understanding of CMC manufacturing documentation requirements for both small and large molecule manufactured products.

Skills and Requirements

• BS or MS in Chemistry, Pharmaceutical sciences, Regulatory Affairs or relevant field.
• 5 years of experience in authoring CMC sections of regulatory filings.
• Experience working closely with other departments.
• Experience in authoring various regulatory filings.
• Demonstrated competency in clear and concise technical writing ability.
• Demonstrated track record of effective leadership including organization and prioritization of 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, drug product.
• Must be well organized, flexible and able to communicate effectively within CMC functions and Regulatory affairs.
• Must be knowledgeable and worked 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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