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Senior Medical Writer

Norwood, MA

Posted: 11/07/2018 Job Category: Clinical: Medical Writing Job Number: 2203

The Senior Medical Writer is responsible for various medical writing initiatives as assigned by the Chief Medical Officer.  The person in this role is responsible for ensuring all documents are written in accordance with applicable regulations and completed on time. 

RESPONSIBILITIES:
  • Provide medical/regulatory writing and editing expertise for protocols and regulatory submission documents (e.g., end of Phase 2 meetings, expedited review applications, Pediatric Investigational Plans, clinical study reports, investigator brochures, meeting packages, IND applications, sections of marketing applications [NDA/MAA/CTD], patient information guides, instructions for use and pharmacovigilance documents)
  • Write, review, and edit clinical and technical documents for organization, clarity, language/grammar, consistency, and scientific standards
  • Coordinate, synthesize, and integrate scientific and medical input from internal and external contributors to meet deliverable and publication deadlines for clinical documents, manuscripts, abstracts, presentations, etc.
  • Author documents while contributing therapeutic expertise, knowledge/skills related to clinical drug development, and scientific/technical expertise
  • Experience in performing medical-database searches (e.g., Medline, PubMed, etc.).
  • Experience as primary author on scientific publications.
  • Generate slide decks and medical affairs deliverables.

SKILLS & REQUIREMENTS:
  • Knowledge of FDA and EMEA regulations, GCP and ICH guidelines
  • Excellent computer skills with experience using Microsoft Word (Word, Excel, PowerPoint) applications to prepare charts, tables, reports and presentations. Experience with email and calendar programs also required.
  • 5+ years’ medical writing experience. Industry medical writing experience strongly preferred
  • NDA experience required
  • Life Sciences degree required. PhD/MS in Life Sciences a plus

Julie Monti
Clinical Recruiter

Julie brings nearly 20 years of experience to her role as Clinical Recruiter for The Steely Group. Throughout her career, she has built lasting relationships and strong partnerships while helping companies build successful teams. Julie is known for her sharp wit, easy smile, sense of humor and genuine interest in people.

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