View Our Website View All Jobs

Clinical Technical Editor / Scientific Document Reviewer

MMS Holdings Inc. is a global pharmaceutical service organization (CRO) that focuses on regulatory submission support for the pharmaceutical, biotech and medical device industries. We support pharmaceutical and biotech industries with medical writing, biostatistics, clinical programming, data management, clinical development, regulatory affairs, regulatory submissions and pharmacovigilance.

Our mission is to deliver high-quality services, rooted in good science and decades of regulatory experience, that will assist our clients in developing and marketing life-changing therapies, thereby positively affecting patients' lives worldwide.

MMS is looking to expand regulatory services within the US. We are looking to add several regulatory strategists with experience in these regions to work with our clients who are planning to run clinical trials, file marketing applications and/or engage in regulatory activities with health authorities in these regions.  Key activities for regulatory strategists are included below

Job Description

Note: This is for a variable hours position (part- to full-time)

The Clinical Technical Editor / Scientific Document Reviewer will be a function of the Medical Writing team. Responsible for quality control of clinical documents and will work collaboratively with medical writers to ensure documents comply with regulatory guidelines.

Coordinate and perform quality control for clinical documents including, but not limited to, clinical protocols, investigator brochures, clinical study reports, patient narratives and clinical summaries of the common technical document intended for submission to regulatory agencies.
Proofread, review and edit clinical documents in support of clinical development projects in multiple therapeutic areas and at various stages of development in order to verify:

Completeness and accuracy of information
Accurate use of grammar and style
Internal consistency of document
Compliance with submission/ready standards
Application of format standards

Works within document management system to ensure security and version control
Ensures consistent QC across authors and documents.
Ability to follow sponsor processes

Requirements 

  • At least 2 years of pharmaceutical industry experience, specifically within a clinical development operations function, and previous hands-on work with regulatory submission documents
  • Preferred: experience with regulated scientific/clinical documentation in a pharmaceutical, biotech or clinical research environment 
  • Demonstrated skill in quality control of documentation and/ or technical editing
  • Excellent written English skills
  • High degree of organization and able to manage multiple projects at any given time
  • Attention to detail and committed to excellence in all aspects of their work
  • Ability to work under pressure, and to work independently and collaboratively with team
  • 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
Read More

Apply for this position

Required*
Apply with Indeed
Attach resume as .pdf, .doc, or .docx (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

150