Medical Writer

LabConnectJohnson City, TN
Onsite

About The Position

LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions. The Medical Writer is responsible for authoring clinical trial and regulatory documents, through independent assignment and oversight as well as engagement within a cross-functional team dynamic. This role requires strategic thinking with exceptional scientific and technical writing skills, excellent communication skills and attention to detail, and the ability to manage and prioritize project load independently.

Requirements

  • Master’s Degree or above and at least 5 years’ experience in medical writing in the Biotech/Pharmaceutical industry OR Bachelor’s degree and at least 8 years’ experience in medical writing in the Biotech/Pharmaceutical industry
  • Experience understanding and interpreting data/information and its practical application
  • Excellent written/oral communication skills and attention to detail
  • Advanced knowledge of scientific/technical writing and editing
  • Strong time and project management skills
  • Strong leadership experience in a team environment
  • Ability to independently prioritize and execute projects in alignment with critical deadlines
  • Industry experience required

Responsibilities

  • Perform all document authoring steps as outlined by document type and template
  • Author clinical trial and regulatory documents
  • Coordinate quality control of clinical trial and regulatory documents
  • Engage with cross-functional team, as needed
  • Develop accurate, clear and compliant documents as per the project and regulatory requirements

Benefits

  • Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
  • Health Benefits beginning on date of hire
  • PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
  • Short and Long-Term Disability, Life Insurance, and AD&D
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