Medical Writer/Senior Medical Writer

Location
Lexington, Massachusetts (US)
Posted
Apr 03, 2018
Required Education
Bachelors Degree
Position Type
Full time

Wave Life Sciences USA seeks experienced and highly motivated individual to join its team in Cambridge, Massachusetts.  The ideal candidate will focus on assuring quality requirements of products to be fulfilled within a team-oriented, fast-paced and cross-disciplinary biotech environment.

The Medical Writer will focus on the preparation, assembly, writing, and review of the analyses and documentation needed in support of clinical trials and corresponding submissions to regulatory authorities including NDA filings. He or she will be responsible for authoring and/or developing clinical and nonclinical regulatory documents

POSITION RESPONSIBILITIES:

  • Write regulatory documents including, but not limited to, Investigator’s Brochures, Protocols, Clinical Study Reports, Nonclinical and Clinical Summary Documents, and Briefing Documents
  • Provide overall medical writing support for other projects and programs (eg, manuscripts, abstracts, SOPs) as needed
  • Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents and ensure consistency between related documents
  • Serve as the lead medical writer on multiple programs; attend team meetings and contribute to program goals, key messages, and timeline discussions
  • Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
  • Review documents, including those authored by others both internally and externally
  • Perform and/or manage quality control reviews of regulatory documents
  • Collaborate within the medical writing department to develop medical writing processes, standards, and department initiatives
  • Ensure clinical documents adhere to Wave standards and regulatory guidelines

EDUCATION/EXPERIENCE:

  • At a minimum, a B.A./B.S. degree
  • At least 3-5 years of relevant industry experience as a regulatory medical writer
  • Excellent writing and communication skills
  • Strong interpersonal skills; a team player
  • Flexibility to function well within a team environment and within condensed timelines
  • Strong project management and organizational skills
  • Understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology
  • Ability to comply with company and/or industry style guides and templates
  • Excellent attention to detail related to consistency, grammar, syntax, and scientific accuracy
  • Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems