Proclinical Staffing | CMC Technical Writer | wilmington, nc
1 week ago
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.
The CMC Technical Writer's responsibilities will be:
- 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 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 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 worked in biotech manufacturing related industry.
- Demonstrate excellent understanding of cGMP manufacturing execution.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raltez@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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