(Senior)Medical Writer (Clinical / Regulatory Documents) - Niche CRO/Remote

Job Type: 
Life Sciences
Other Life Science Positions
Clinical Research and Development
Employment Category: 
Direct Hire

Our client, a niche CRO that specializes in Ophthalmology trials, is actively recruiting for several skilled and knowledgeable Medical Writers, with particular strength in clinical and regulatory documents, to join its Clinical Development team.  These positions are open due to steady and substantial growth.  There are multiple needs.

Key Things to Note:

  • These positions are remote and can be located anywhere within the US. 
  • These are Direct Hire roles. 
  • This CRO focuses on in posterior and interior segments of ophthalmology.  Ophthalmology experience is a plus but not a must.
  • These are a client-facing roles whereby the Medical Writers will lead discussions with the Clinical Development teams.  We seek writers who enjoy the interface.
  • These Medical Writers (client is open on level) will prepare regulatory and clinical documents (see examples below).  Some experience in Clinical Research will be important. IND and NDA experience is required for Senior level candidates.
  • These are relatively independent roles in a highly collaborative environment.  The right candidate will be a skilled self-starter who is also a team player. This is a great place to work.

This Medical Writer will prepare a wide range of documents to include:

  • Clinical Study Reports (CSR)
  • Clinical summary documents for marketing applications
  • Protocols and Protocol Amendments
  • Investigator’s Brochures (IB)
  • Investigational New Drugs/Investigational Medicinal Product Dossiers (IND and IMPD)
  • Regulatory responses
  • Briefing packages
  • New Drug Applications:
    • Clinical Summaries (ISS/ISE)
    • Executive Summaries
  • White papers
  • Risk management plans

Other duties will include:

  • Project Management of assigned projects
  • QC of written materials, including protocols and clinical study reports
  • Lead Kick-Off and Roundtable discussion for protocols and CSRs
  • Perform background research
  • Provide guidance to clients for best practices for developing assigned documents

Targeted candidate will offer a scientific degree and 2-5+ years of clinical research experience to include medical writing experience.  Experience working on FDA-regulated drug trials is a must (device experience welcome), Ophthalmology experience is a plus.

Further, we seek candidates with broad knowledge of the drug development cycle and regulatory standards. 

Other priorities include:

  • Knowledge of current best practices and regulations regarding clinical documents
  • Exceptional written communication including professional understanding of writing protocols and standards
  • Outstanding organizational skills
  • Keen attention to detail
  • Polished verbal communication skills

Finally, we seek client service-oriented professionals who enjoy partnering and acting as the client liaison, understanding the client needs and expectations and ensuring exceptional service delivery.  This client prides itself on its outstanding reputation for excellence.  We seek quality-driven candidates who will extend that reputation.

Please forward Word resume for prompt consideration.