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Manager, CMC Technical Writer

Andover, MA

Posted: 10/15/2018 Job Category: Clinical: Medical Writing Job Number: 2158

Location: Andover, MA

Summary:
Reporting to the Sr. Director, API Process Development, this position is part of the Process Development team and will focus on development plans, proposals and report writing for the platform process development of PMO and PPMO technologies. He/she will also lead in the authoring of CMC (Chemistry, Manufacturing and Controls) regulatory documents and filings. This position will also support strategic planning and execution of PPMO platform technology development, and continuous improvement of PMO platform technology, in conjunction with cross functional teams. The ideal candidate will be highly organized with competencies in all aspects of technical writing and process development, especially in support of IND enabling activities, including: demonstrated subject matter expertise, effective interpersonal skills, and familiarity with IND and NDA filing requirements.

Job Responsibilities Include:
  • Gather information/content for CMC regulatory documents from subject matter experts in Process Development, Manufacturing, Quality Control, and Regulatory Affairs
  • Manage the preparation of CMC sections of a variety of documents to support all phases of clinical drug development (e.g. Investigational New Drug (IND) submissions, amendments and annual reports; New Drug Application (NDA) submissions)
  • Author and review technical protocols, reports, memorandums, records, and related correspondence
  • Retrieve and compile data from electronic sources/databases and paper records
  • Collaborate across discovery Research, Process Development, Manufacturing, Quality, Regulatory Affairs and external collaborators to meet project timelines and corporate objectives
  • Support the routing of documents for review and approval in conjunction with the use of an electronic document system including reconciling of comments from multiple reviewers

Job Requirements/Qualifications:
  • Bachelor’ s Degree in Pharmaceutical Sciences (Chemistry, Engineering or other related science-based discipline)
  • 4-6 years of direct experience in a role with emphasis on technical writing
  • 2+ years of experience in an FDA (or other regulatory body) regulated (cGMP) pharmaceutical/biotech manufacturing environment strongly preferred
  • Deep understanding and strong technical background in modern analytical science, and demonstrated  track record of their application in process development
  • Experience in performing reviews of technical documents such as batch records, development protocols and reports, regulatory (e.g. FDA and ICH Guidances), compendial (e.g. USP and EP), and literature/3rd Party Reports (e.g. CRO Reports)
  • High degree of knowledge/skills in word processing, spreadsheets and presentation software (e.g. MS Office suite) required
  • Ability to work collaboratively in a cross-functional team environment with all levels of personnel
  • Detail-oriented with excellent writing skills; ability to effectively communicate complicated scientific and technical information
  • Experience in new drug application (NDA) submissions preferred
  • Knowledge of chemical drawing software (e.g. ChemDraw) preferred
  • Demonstrated track record of close alignment with company values of teamwork, excellence, innovation, drive, compassion, and resilience
  • Candidates must be authorized to work in the U.S.

Lisa Madden
Recruiting Consultant

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