Remote Clinical Technical Editor

  • Location:
    Anywhere Anywhere Anywhere Anywhere
  • Salary:
    negotiable
  • Job type:
    Full-Time
  • Posted:
    3 weeks ago
  • Category:
    Remote Writing Jobs
  • Deadline:
    June 15, 2020

Remote Clinical Technical Editor

#remote #clinical #technical #editor

Company: Merck

Our Clinical Research and Pharmacovigilance team 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 support of 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 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 our Company’s 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.
    • 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.
  • 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

Education:

  • BA/BS 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 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.

Additional Skills:

  • 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 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.
  • 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” and that great medicines can make a significant impact to our world. And 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.

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

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.

INVENT.

IMPACT.

INSPIRE.

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.

If you need an accommodation for the application process please email us at [email protected]

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