What are the responsibilities and job description for the Proclinical Group is hiring: CMC Technical Writer in Wilmington position at Proclinical Group?
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)
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