Medical Writing/Team Lead (Clinical/Regulatory) – Home-based/ Direct Hire

Job Type: 
Life Sciences
Other Life Science Positions
Employment Category: 
Direct Hire

Our client, a niche provider of Regulatory Support and Medical Writing services to the pharmaceutical and biotech industries, is actively recruiting for an experienced and knowledgeable Medical Writer, to assume key role on its client services team. 

This company is located in Raleigh but is open to home-based candidates nationwide. This is a critical role and company will offer generous wage to attract and retain the right candidate(s).

Key Things to Note:

  • This company is experiencing enormous growth.  Worldwide drug development activity is exceptionally high right now and the writing demands are increasing accordingly.  This firm seeks to add (several) Medical Writers to its team.  This will be a Team Lead.
  • This is a hybrid role – handling original writing while overseeing/editing the work of others.  Seek candidate who enjoys both.
  • This Medical Writing team handles scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics. Right candidates will offer 8+ years of clinical/regulatory writing experience.
  • In addition to document writing, this Medical Writer will coordinate, edit and/or review the work of others.  We seek a skilled project leader.
  • This is a client-facing role.  Right candidate will complement strong technical skills with excellent relationship-building and client service skills.
  • This is a relatively independent role in a highly collaborative environment.  Right candidate will be a skilled self-starter who is also a team player.

This Medical Writer will prepare a wide range of documents including:

  • Clinical study reports (CSRs)
  • Subject narratives
  • Clinical investigator brochures
  • Protocols
  • Briefing documents
  • Clinical sections of Investigational New Drug (IND) Applications and New Drug Applications (NDAs)
  • Sections of Biologics License Applications (BLAs) (e.g., integrated summaries of safety and efficacy, product labeling, and summaries and overviews of nonclinical and clinical information)

Targeted candidate will offer an advanced degree in life or health sciences and 8+ years of medical writing experience in a pharmaceutical company, contract research organization (CRO), or comparable environment.  Experience preparing and/or reviewing CSRs, clinical sections of INDs, NDAs, BLAs, etc. are all important.

Other priorities include:

  • Broad knowledge of the drug development cycle and regulatory standards
  • Knowledge of current best practices and regulations regarding the documents noted above
  • Keen attention to detail
  • Outstanding organizational and project management skills
  • Polished written and verbal communication skills

Finally, we seek a skilled client service professional who enjoys partnering with client liaisons, understanding their needs and expectations and ensuring exceptional service delivery.  This client prides itself on its outstanding reputation for excellence.  Seek quality-driven candidate who will extend that reputation.

This is a Direct Hire role and an immediate need.  Please forward Word resume for prompt consideration.