Lead QCOperations Medical Writer

Fairfield - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Job Description

Contact: Alexandra Spink -
No 3rd party candidates

We are seeking a hands-on detail-oriented professionalto support Quality Control (QC)and operational excellencewithin the Medical Writing function. This role will closely partner with the Head of Medical Writingto 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.

Job DescriptionContact: Alexandra Spink -No 3rd party candidatesWe are seeking a hands-on detail-oriented professionalto support Quality Control (QC)and operational excellencewithin the Medical Writing function. This role will closely partner with the Head of Medical Writingto optimize vendor proces...