Search Jobs

So sorry, this position is no longer available. Please go ahead and submit your application. We may have other positions that would be the perfect fit for you. Alternatively, you may want to apply to one of the following related jobs:

Lead QC/Operations Medical Writer - Remote

Fairfield, CT

Posted: 09/26/2025 Industry: Biotech/Pharmaceutical Job Number: 5995

Job Description

Contact: Alexandra Spink - aspink@penfieldsearch.com
No 3rd party candidates

We are seeking a hands-on, detail-oriented professional to support Quality Control (QC) and operational excellence within the Medical Writing function. This role will closely partner with the Head of Medical Writing to optimize vendor processes, drive efficiencies, and uphold the highest standards of quality and compliance across clinical and regulatory documents.

Key Responsibilities

  • Lead QC reviews for protocols, CSRs, IBs, clinical summaries, and plain language documents.
  • Manage document redactions to ensure global transparency compliance.
  • Support or lead the development of Plain Language Protocol Summaries and Lead Author contributions.
  • Partner with the Head of Medical Writing to manage vendor workflows, SOPs, and process improvements.
  • Maintain and enhance SOPs, templates, and QC tools; support dashboard reporting and metrics tracking.
  • Collaborate cross-functionally to ensure high-quality, audit-ready documentation.


Qualifications

  • Advanced degree in life sciences (PhD or PharmD preferred).
  • 7+ years of experience in medical writing and QC within pharma, biotech, or CRO environments.
  • Strong expertise in redaction practices and document compliance.
  • Solid understanding of ICH/GCP guidelines and familiarity with document systems.
  • Operational mindset with proven ability to improve processes and manage vendor relationships.

Meet Your Recruiter

Alexandra Spink, BSN, RN
Director, Clinical Recruitment

With a dedication to serving others, Alexandra spent many years caring for tiny patients and their families as a Neonatal ICU Registered Nurse prior to joining Penfield as a Clinical Recruitment Specialist in their Contract Staffing Division. Transitioning into the staffing realm, she now seamlessly merges her clinical background with her fervent desire to assist others. Today, she utilizes this unique fusion to facilitate the connection of top-tier talent to promising opportunities within the pharmaceutical and biotech industries.

 

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Fairfield, CT

Ready to take your career to new heights? Explore job opportunities in beautiful Fairfield, Connecticut, where coastal charm meets bustling city life. This vibrant area offers a perfect blend of picturesque beaches, historic landmarks like the Fairfield Museum, delectable local cuisine, and a thriving arts scene including the Regina A. Quick Center for the Arts. With proximity to New York City and easy access to outdoor recreational activities at places like Lake Mohegan, Fairfield is an ideal location for professional growth and work-life balance. Don't miss out on the chance to join this dynamic community – browse our job listings today!