Regulatory CMC Writing Contractor

RCM Technologies Waltham, Massachusetts
regulatory cmc writing cmc regulatory rcm remote team module coordinate writer onsite life sciences
March 18, 2023
RCM Technologies
Waltham, Massachusetts
Job Title: Regulatory CMC Tech Writer
Job Function: Preparing CMC Regulatory Applications
Job Type: 6 months to a year plus contract
Location: Remote and/or Onsite - Waltham MA

About RCM:
RCM IT & Life Sciences is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.

About Our Client:
Our Client is searching for an experienced and highly motivated team player to join our Regulatory CMC writing group. This individual will prepare CMC documents for marketing/registration applications to support our global oncology programs. They will author high-quality ICH Module 3 from source documents, prepare the related Module 2.3 documents, and coordinate all activities related to creating submission-ready documents for submission to health authorities. No direct or indirect supervision of staff is expected.


Candidate must be able to:
  • Work cross-functionally to execute CMC regulatory strategies
  • Author and coordinate the activities required for finalization of documents, ensuring the review for completeness and accuracy, and data verification
  • Copyedit documents, ensuring alignment with internal style guide
  • Exercise good judgment in elevating and communicating current or potential issues to line management
  • Effectively prioritize and track tasks
  • Plan and execute to achieve established deadlines
Candidate Description:
  • Has a Ph.D or a Master s degree with experience in regulatory CMC, including authorship of CMC documents for the US, Europe and/or Canada commercial dossiers
  • Has post-approval experience in biologics (antibodies preferred)
  • Has strong knowledge of current US and EU regulations and guidance, and Good Manufacturing Practices (cGMP)
  • Understands scientific principles and is able to interpret technical reports and translate them into a dossier that reflects a risk-based approach and principles related to established conditions
  • Has strong knowledge of eCTD elements and structure
  • Uses concise and precise language to effectively convey key messages
  • Has a track record of strong verbal and written communication skills
  • If remote candidate, has demonstrated the ability to work effectively within a cross-functional team in a remote setting
Education & Certifications

Ph.D or a Master s degree

Equal Opportunity Statement

RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

#Monster

Questions or Resumes:
[email protected]
973 658 3115

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