Medical Writer (Contract w2 or 1099)

Highly Competitive Salary
  1. Permanent
  2. Medical Writing
  3. United States
Cambridge, USA
Posting date: 06 Dec 2019
MC.GW.26846_1575651254

Proclinical is currently recruiting for a contract Medical Writer for a communications company located remotely from home. Successful candidate will be responsible for the creation, content development, formatting, editing, review and/or updates to of any document that supports regulatory interactions or meetings (e.g., briefing documents for meetings with regulatory agencies, briefing document for CHMP Oral Explanation or SAG, briefing books for drug/biologic advisory committee meetings, panel packs for device advisory committee meetings, clinical protocols, applications for approval).

Job Responsibilities:

  • Write briefing documents for FDA Advisory Committee meetings
  • Experience working on 10+ briefing documents for drug (new indications, generics, OTCs), biologic, biosimilar, and medical device submissions
  • Manage completion of briefing document with Sponsor, including scheduling and leading meetings, assigning tasks, and planning timelines
  • Work directly with Sponsors and utilize clinical trial and regulatory submission documents to identify key information for the Advisory Committee

Skills and Requirements:

  • 2+ years of experience in medical writing.
  • Write briefing documents for FDA Advisory Committee meetings
  • Flexibility of 2 weeks of traveling per year
  • Familiarity with Microsoft Office programs, including MS Word, Excel and PowerPoint.
  • Familiarity with Salesforce, Dropbox, Citrix preferred.
  • Excellent people skills, with an ability to partner with a dynamic leadership team.
  • Excellent written and verbal communication skills.
  • Possess personal qualities of integrity, credibility, and commitment to corporate mission.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call George Watson at (+1) 929-223-4835 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-GW1
#MedComms

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