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Medical Writer

Cambridge, Massachusetts

Post Date: 01/10/2018 Job ID: 1640 Job Category: Clinical: Medical Writing

The medical writer will be a key member of the Project Team and will work closely with Research, Clinical Operations and Regulatory Affairs to manage all aspects of document preparation for clinical and regulatory documents according to company guidelines and international governmental regulations. S/he will provide strategic direction to cross-functional teams to ensure that key messages are consistently aligned with reporting requirements and company objectives.

Responsibilities 
  • Plan, prepare, write, edit, format, and finalize non-clinical, clinical and regulatory documents. Documents will include, but are not limited to: IND, CTA, non-clinical summaries, clinical protocols, clinical study reports, Investigator brochures, updates to regulatory submissions, annual reports/development safety update reports (DSURs) etc.
  • Assist in developing strategy for organizing and preparing documents for regulatory health authority submissions.
  • Coordinate the internal review of documents.
  • Develop, maintain, and drive document finalization timelines.
  • Ensure final document adheres to standard operating procedures (SOP), good clinical practice (GCP), and the International Council on Harmonisation (ICH).
  • Perform quality control review of medical writing documents
  • Assist in the development of templates, style guidelines, and SOPs for clinical documentation

Requirements
  • Minimum requirement of a bachelor’ s degree with 3-5 years of medical writing experience in a pharmaceutical/biotechnology or CRO environment
  • Ability to interpret and present clinical and non-clinical data objectively in a clear, concise format.
  • Outstanding written and oral communication skills
  • Proficiency in teamwork, organization, and project management
  • Proficiency in MS Office; experience using electronic document management system

 

Denise Kowalski
Clinical Recruiter

Denise is a focused, relationship-driven individual who brings creative energy and an eagerness to conquer new challenges to her role. A passionate life-long learner, Denise’s excellent communication skills, strong work ethic, and genuine interest in helping others make her a valuable asset to the Clinical team.

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