CMC Technical Writer

Proclinical Staffing - Wilmington, DE

Full-time - Mid Level

Wilmington, DE

About the position

The CMC Technical Writer will be responsible for authoring and compiling CMC sections for global regulatory filings within a pharmaceutical company. This role requires a strong understanding of the drug development process, pharmaceutical technology, and regulatory requirements, while collaborating with cross-functional teams to meet technical writing objectives.

Responsibilities

• Manage the CMC regulatory writing strategy for high-quality and compliant regulatory CMC documentation (e.g., INDs, CTAs, MAAs, CASs, NDAs Variations/Supplements) within defined timelines.
• Facilitate communication and flow of regulatory information to all relevant stakeholders.
• Determine regulatory and scientific/technical requirements for CMC and GMP related submissions.
• Work closely with the Technical Operations team to align priorities with corporate goals.
• Collaborate with Quality Assurance and Regulatory Affairs to ensure documentation excellence.
• Maintain knowledge of CMC regulatory requirements for small molecules development through post-approval and annual updates.
• Utilize experience in US, Europe, Japan, and Canada submissions and knowledge of guidelines.

Requirements

• 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 departments such as Process Chemistry, Analytical, PDMs, Reg. Ops, and Regulatory Affairs.
• Demonstrated competency in clear and concise technical writing ability.
• Understanding of CMC manufacturing documentation requirements for small molecule products.
• Proven leadership skills including organization and prioritization of workload.
• Strong communication skills and proven negotiation skills.
• Good decision-making abilities with strong judgment through collaboration.
• Sound technical knowledge of process chemistry, analytical methods, and drug product.
• Well organized, flexible, and able to communicate effectively within CMC functions and Regulatory affairs.
• Knowledgeable and experienced in the biotech manufacturing industry.
• Excellent understanding of cGMP manufacturing execution.