A large, well respected Pharma company is in search of a CMC Technical Writer with a strong regulatory background, with a particular focus on Module 2 and Module 3 sections.
The Technical Writer is responsible for converting scientific data into clear, scientifically sound, well-structured scientific, technical and regulatory documents intended for global health authorities and internal/external stakeholders. The job scope is focused on authoring and managing the review and approval of moderate to complex CMC regulatory documents, including but not limited to Module 2 and Module 3 CMC regulatory submissions for development and post-approval dossiers, technical reports and SOPs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Independently write and format CMC documents for US and global regulatory submission including:
- Module 2 and Module 3 CMC sections for development and post-approval dossiers in eCTD format
- CMC technical reports, including process and analytical validation summaries
- Standard operating procedures for PSC department processes
- Interpret technical and scientific data as needed to prepare documents
- Ensure that documentation conforms to International Conference on Harmonization (ICH) and other relevant regulatory guidelines; ensure that appropriate documented quality control (QC) checks are performed and recommends quality process improvements;
- Ensure documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in appropriate document management system(s).
- Contribute to the development and maintenance of the PSC working practices and procedures, as well as help update and maintain procedures and templates
- Project manage assignments include:
- Manage the document review process and schedule meetings to ensure documentation timelines are achieved, providing status updates as necessary to stakeholders
- Work on multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with project managers
- BA/BS and 5-10 years of experience in medical/technical writing; or MS and 4 years of experience in medical/regulatory writing.
- Possess substantial Chemistry, Manufacturing and Controls (CMC) knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation.
- A background of pharmaceutical manufacturing or quality control/quality assurance is a plus. A working knowledge of cGMP’s is desired.
- Superior working knowledge of software programs in Windows environment with excellent proficiency in word processing, flow diagrams, and spreadsheets.
- Ability to learn fast, grasp the “essence” of a strategy or a story quickly to convert relevant scientific data/information into high quality summaries and reports.
- Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects and/or other writers simultaneously.
- Well-developed analytical skills and strong knowledge of technical terminology.
- Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
- Uses professional concepts and company’s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
Posted 1w ago
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