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Medical Writer (East Coast Region)

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Title: Medical Writer
Position Type: Permanent
Location: Raleigh, NC or Remote

Brio Resource Group is a search firm committed to providing rare pharmaceutical talent on an executive search basis to the Pharmaceutical, Biopharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging companies. Our many years of experience, subject matter expertise, proven search process and genuine passion to deliver rare talent defines Brio.

Our client is seeking a Clinical Medical Writer for an immediate hire, to work with a team of Medical Writers/ Clinical Research Scientist to design, coordinate and provide oversite of carious clinical trials.

This is a highly strategic role reporting directly to the VP of Regulatory Affairs leading writing efforts for submissions, protocol development, statistical analysis, scientific publications for their expanding oncology and hematological portfolio. Company embraces a flexible remote work-from-home culture. Position includes generous salary, bonus, and equity plan.

Responsibilities:

  • Responsible for the process, content, and planning expertise to clinical development, submission strategy, and scientific messaging for pivotal oncology clinical trials
  • Research and producing high-quality written scientific communication materials such as manuscripts and other documents for publication (e.g., review articles, abstracts)
  • Managing the review and approval process of clinical submissions documents
  • Develop, write clinical study documents including clinical trial protocols, Investigator Brochures, clinical sections of regulatory submissions, and clinical study reports.

Requirements:

  • B.A., B.S., M.S., and/or Ph.D. degree
  • 6 to 15+ years’ experience in Medical Writing roles in a Biopharma, Pharmaceutical or CRO company.
  • Expert knowledge of ICH guidelines, regulatory requirements for the US and EU authorities and submission process
  • Participation in NDA submissions

How To Apply:

Please submit your CV to CV@briogrp.com or click “APPLY. An appropriate member of our executive recruitment team will review your credentials and respond to arrange an initial interview to review your credentials and career objectives.

We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.

Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status