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Careers

Senior Medical Writer (Contract-Fully Remote) - Growing Medical Writing and Consultancy Firm

Brief Company Overview
Here at FBL ClinWriters, we are passionate about making sure that we work with clients that foster collaborative interactions!! We are a growing niche-specific medical writing and consulting firm. We support the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. We specialize in immuno- oncology, infectious disease, and autoimmunity drug development writing strategy. Our team has strong therapeutic area experience and navigates through the rigorous regulatory standards of new drug application submissions by using superb medical writing and project management practices. FBL ClinWriters is looking to expand our team of remote medical writers and consultants. For more information, visit www.fblclinwriters.com or submit your CV to admin@fblclinwriters.com.

Position Summary
Serves as a senior medical writer on clinical or regulatory writing projects and continuing medical education writing projects. Plans and coordinates writing activities with dependent staff roles to ensure satisfactory completion of all writing projects, as well as mentors and leads less experienced medical writers on complex projects.

Position Responsibilities

  • Mentor and leads less experienced medical writers on complex projects, as necessary.
  • Compiles, writes, and edits medical writing deliverables, and serves as a medical writer on internal and external project teams with minimal supervision. Provides medical writing deliverables covering late-stage phases of clinical research (Phase 2 and 3) and in immunology and infectious disease therapeutic areas.
  • Creates writing deliverables that include, but may not be limited to clinical study reports, integrated summary reports, and NDA (e)CTD submission modules.
  • Creates continuing medical education slide decks.
  • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
  • Interacts with client department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing
    deliverables.
  • Serves as peer reviewer on internal review team.
  • Performs on-line clinical literature searches, as requested.

Requirements

  • PhD, MD, or PharmD degree with a minimum of 3-5 years of pharmaceutical industry regulatory and clinical medical writing experience.
  •  Understanding of clinical data.
  •  Exceptional writing skills are a must.
  •  Excellent organizational skills and the ability to multi-task are essential prerequisites.
  •  Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools.
  •  Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
  •  Substantial Oncology, Immunology, and/or Infectious Disease experience required.
  • Substantial eCTD authoring, as lead author, required.
  • Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
  • Regulatory or medical writing certification a plus.
  • Experience in regulatory submissions (pivotal clinical study reports) presented to regulatory authorities a plus.

Travel Requirements
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2530 Meridian Parkway (HQ)
2nd & 3rd Floors, Durham, NC 27713
(o) 919-421-7826
admin@fblclinwriters.com

101 Federal Street, Suite 1900
Boston, MA 02110
1390 Market Street, Suite 200
San Francisco, CA 94102