Beacon Hill Staffing Group

CMC Regulatory Technical Writer

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.

SUMMARY:

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

EDUCATION/EXPERIENCE/SKILLS: 

  • 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.

JOB COMPLEXITY:

  • 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.
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Made with ♥ in Philly.