Our Clinical Research and Pharmacovigilance teams push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
The Medical Writing Department of the Global Clinical Trial Operations (GCTO) organization prepares a variety of regulated documentation in for the clinical development portfolio. The Clinical Technical Editor (CTE) is a member of the Medical Writing team who is accountable for quality control of clinical documents intended for submission to regulatory agencies.
In this role the CTE will:
- Coordinate and perform our Company's 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 necessary.
- Ensure documents comply with appropriate International Council on Harmonisation and regulatory guidance.
- Work 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 for clinical development projects in multiple therapeutic areas and at various stages of development according to our Company's SOPs and guidelines to verify: completeness and accuracy of information.
- Verify accurate use of grammar and style.
- Verify consistency of text with internal document data displays as well as external reference sources.
- Apply format standards for electronic documents.
- Ensure 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 control are maintained.
- Promote 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.
- BA/BS degree or higher
Skills and Experience:
- At least 2 years of editing and/or quality control of scientific/clinical documentation in a pharmaceutical, biotech, clinical research, or related environment, 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 dedication to excellence in all aspects of the work.
- Ability to work under pressure and to work solely and collaboratively with teams.
- Excellent communication and interactive skills and ability to maintain a positive attitude under pressure.
- Advanced Microsoft Word skills (including the use of electronic Word templates) and Adobe Acrobat.
*Can be remote based
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements: