About the Company
Our client, a biotechnology industry-leader focused on breakthrough treatments for rare diseases, is currently seeking a CMC Technical Writer for their Greater Boston Area location.
The Technical Writer will be responsible for preparation of high quality regulatory submissions and a wide range of supporting documentation across the drug development life cycle. Key responsibilities include:
- Regulatory submission for pipeline programs, Marketing Applications, Agency request for information, Briefing Books, Post- Approval changes or compliance updates.
- CMC technical writing and editing assignments related to the preparation of CMC components of regulatory submissions and other technical documents such as protocols, reports and procedures.
- Participating in the development, implementation and maintenance of company policies, guidelines and procedures that pertain to the preparation of CMC regulatory submissions to ensure compliance with current regulatory expectations.
- Working cooperatively with colleagues in applicable functions or departments (e.g., R&D, Process Development, Manufacturing, Supply Chain, Regulatory Affairs, Validation, Quality Control and Quality Assurance) and external organizations (e.g., CMO) to ensure achievement of company objectives relating to the preparation of CMC regulatory submissions and associated activities.
- Organization support and project team participation including strategy meetings, information gathering, progress reports and presentations etc.
Share This Position:
- Minimum 5-8 years’ experience in the Pharmaceutical Industry, or relevant Regulatory environment.
- Bachelor’s degree in Chemistry, Chemical Engineering, Pharmacy, or closely related field is required, Advanced degree preferred
- Experience in writing CMC components of regulatory submissions together with knowledge of relevant regulatory agency guidance including ICH, FDA, EMA, and authorities in other major geographic areas is essential
- Knowledge of drug development requirements for both biologics and chemically synthesized products, as well as devices and combination products
- Must be detail oriented and articulate with ability to write in a precise, clear style
- Must have drive and energy to multi-task in a fast-paced environment, with flexibility and strength to navigate through crises
- Proficient in use of Windows environment software with advanced skills in Microsoft Word
- Must be a strong team member with demonstrated ability to work collaboratively with others as well as being able to take initiative and exercise independent judgment.