Senior Medical Writer (Clinical/Regulatory Documents) – Work from Home Options/ Direct Hire

Job Type: 
Regulatory Affairs and Medical Affairs
Employment Category: 
Direct Hire

Our client, a niche provider of specialized services to support the pharmaceutical and biotech industries, is actively recruiting for a skilled and knowledgeable Medical Writer with particular strength in clinical and regulatory documents, to assume key role on its client services team. 

Local, in-office candidates are preferred but client will consider remote candidates who have the ability to be in the office on a semi-regular basis.  Client is prepared to pay industry-leading wage to attract and retain the right candidate.

Things to Note:

  • This company provides a wide range of drug development support, with particular focus on Regulatory Affairs and Medical Writing Services.  They have a sterling reputation for excellence, and growth has been substantial.
  • This Medical Writer will prepare scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics.
  • Ideal candidate will be an experienced Medical Writer, but client will also consider Clinical Research professionals who have significant experience writing Clinical Study Reports.
  • In addition to document writing, this Medical Writer may coordinate, edit and/or review the work of others.  We seek a candidate who enjoys a project leadership role.
  • 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)

In addition, this Medical Writer may assume project leadership positions (e.g., managing IND/NDA/BLA submissions) and may coordinate the activities of other Medical Writers and/or internal staff.

Targeted candidate will offer an advanced degree in life or health sciences and 3+ 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. 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, and importantly, 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.