Proclinical Group is hiring: CMC Technical Writer in Wilmington

CMC Technical Writer - Contract - Wilmington, DE

Proclinical is working alongside a pharmaceutical company seeking a CMC Technical Writer to join their team in Wilmington, DE. In this role, you will be responsible for authoring and compiling CMC sections for global regulatory filings.

Primary Responsibilities:

The successful candidate will possess a strong understanding of the drug development process, pharmaceutical technology, and regulatory requirements. Additionally, work closely with cross-functional teams to ensure all CMC technical writing objectives are met.

• Manages the CMC regulatory writing strategy of high quality and compliant regulatory CMC documentation (e.g., INDs, CTAs, MAAs, CASs, NDAs Variations/Supplements and other relevant regulatory filings) for the assigned product(s) within defined timelines as per R&D and business objectives.
• Facilitates the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders.
• Responsible for determination of regulatory and scientific/technical requirements for CMC and GMP related submissions.
• Work closely with the Technical Operations team to ensure alignment and established priorities to meet corporate goals.
• Work collaboratively and transparently with Quality Assurance and Regulatory Affairs to ensure a high-quality level of cGMP produced documentation excellence.
• Strong understanding of drug development process, pharmaceutical technology, drug manufacturing processes, analytical and GMP.
• CMC regulatory requirement knowledge for small molecules development through post approval and annual updates.
• US, Europe, Japan and Canada submissions experience and knowledge of guidelines.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• BS in Chemistry, Pharmaceutical sciences, Regulatory Affairs or other relevant fields.
• 3-5 years of experience in authoring CMC sections of regulatory filings.
• Experience working closely with other departments such as Process Chemistry, Analytical, PDMs, Reg. Ops and Regulatory Affairs.
• Demonstrate competency in clear and concise technical writing ability.
• Understand CMC manufacturing documentation requirements for small molecule manufactured products.
• Demonstrate track record of effective leadership including organization and prioritization of workload.
• Strong communication skills (e.g., clear and concise), team player, and proven negotiation skills.
• Good decision making with strong judgment through collaboration and consideration of others' points-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 have worked in the biotech manufacturing related industry.
• Demonstrate excellent understanding of cGMP manufacturing execution.