Clinical Technical Editor
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Medical Writing Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio. The Clinical Technical Editor (CTE) is a member of the Medical Writing team who is responsible for quality control of clinical documents intended for submission to regulatory agencies.
In this role the CTE will
- Coordinate and perform the Merck Quality Control (QC) process for clinical documentation that includes, but is not limited to, clinical protocols, investigator brochures, clinical study reports (including administrative appendices), patient narratives, and clinical modules of the common technical document. Oversight of external resources for QC may be required.
- Ensure documents comply with appropriate International Council on Harmonisation and regulatory guidance.
- Work collaboratively with internal and external medical writers, regulatory publishers, and project team members to deliver high-quality clinical documentation in a timely manner.
- Review and edit clinical documents in support of clinical development projects in multiple therapeutic areas and at various stages of development according to Merck SOPs and guidelines to verify
- Completeness and accuracy of information;
- Accurate use of grammar and style;
- Consistency of text with internal document data displays as well as external reference sources;
- Application of format standards for electronic documents; and
- Compliance with submission-ready standards.
- Ensure consistent QC and good document practices are followed across internal authors, vendors, and external partners.
- Work within the document management system to ensure security and version controlled are maintained.
- Support the development, implementation, and periodic review of editorial management procedures.
- Support medical writers on the use of tools and technologies to facilitate efficient and compliant document delivery.
- College degree in the area of English literature, technology, or science
- At least 2 years of editing and/or quality control of scientific/clinical documentation in a pharmaceutical, biotech, clinical research, or related environment is required, with specific experience in the pharmaceutical industry within a clinical development operations function and previous hands-on work with regulatory submission documents preferred.
- Excellent written English skills
- High degree of organization and ability to manage multiple projects at any given time
- Attention to detail and commitment to excellence in all aspects of the work
- Ability to work under pressure and to work independently and collaboratively with teams
- Excellent communication and interpersonal skills and ability to maintain a positive attitude under pressure
- Advanced Microsoft Word skills (including the use of electronic Word templates) and Adobe Acrobat
- Experience in the use of a Doc base system or similar Electronic Document Management system
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Clinical Research - Clin Ops
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck