Beam Therapeutics
Published
June 17, 2021
Location
Cambridge, MA
Job Type
Work Setting
In-office

Description

Beam seeks a Senior Medical Writer who will be responsible for creating, authoring, and leading the management of key documents for programs, regulatory filings, clinical studies and external publications, such as clinical protocols (and amendments), clinical study reports, subject consent forms, investigator’s brochures, product dossiers, integrated safety and efficacy summaries, and other documents required for regulatory submissions, abstracts, posters and manuscripts. Working across functions, such as clinical operations, computational sciences, regulatory affairs, medical, biostatistics, new product planning, program management, the Senior Medical Writer will represent Medical Writing on study execution teams.

Responsibilities:

  • Sound understanding of clinical research, drug development, required regulatory guidance’s
  • Development and management of global data transparency plans for each development program, which may include study participants, patients, HCPs, and the public.
  • Data transparency planning experiences, including
  • Ensure compliance with disclosure requirements on public websites
  • Share data with both study subjects and researchers (PhRMA/EFPIA commitments)
  • Maintain alignment with journal publications
  • Evaluate, analyze, and interpret the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, scientific rigor
  • Contribute to statistical output plan concerning organization and table layout for a specific document
  • Project manage, strategic design, planning, team input and reviews
  • Perform literature-based research to support writing activities
  • Participation in industry wide initiatives, both nationally and globally
  • Work closely with regulatory team and nonclinical medical writer on regulatory document submissions
  • Work in collaboration with clinical development team on manuscript preparation and acceptance

Qualifications:

  • BS or MS, PharmD or Ph.D. preferred in a life science of health discipline
  • 5-10 years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
  • A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
  • Demonstrated understanding of standard clinical document types (i.e., protocol, investigator’s brochure, clinical study reports, etc.) and experience as a lead author with such documents
  • Excellent communication skills, both oral and written
  • Strong interpersonal, negotiation, verbal, and written communication skills
  • Ability to build global cross-functional relationships and work collaboratively across functions
  • Strong organizational and meeting skills and attention to detail
  • Experienced in resource planning and management experience with virtual teams
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