Editor/QC/Medical Writer

Troy - Michigan - United States - Life Sciences & Health Care - Pharmaceutical - Clinical - Academic Bachelor

Position Summary

The Editor/QC Specialist provides clinical and scientific quality checks for all clinical study and submission documents for assigned projects. The role is responsible for support of medical writing and T&D activities involved in US, European, and other regulatory submissions. The Editor/QC Specialist will be accountable for ensuring that deliverables are in line with Teva’s Authoring and QC standards and checklists.

Feel free to contact

Haley Davies, Account manager

Apply now

About this role

Responsibilities

  • Performs accurate and precise editing or proof-reading to include spelling, grammar, punctuation and verification of data.
  • Assesses validity of clinical statements described in documents provided to governmental Health Authorities and identify discrepancies.
  • Provides independent clinical review of clinical summary documents, study reports, Investigator’s Brochures, Clinical Protocols, Briefing Books, etc, prior to submission to Health Authorities.
  • Ensures quality and timeliness of reviewing and editing of clinical documents and submissions.
  • Verifies content to ensure accuracy (100% review) of all factual statements within document text compared to post-text sources cited (when appropriate).
  • Verifies numeric accuracy (100% review) of all data cited throughout text compared to in-text or post-text tables.
  • Verifies citation notation on all internal and external citations noted within summary document.
  • Ensure compliance of document format per the template and Style Guide.
  • Develops and provide factual evidence to support all discrepant findings for review and approval by Submission Team or document authors.
  • Mentors and/or trains new or junior QC specialists to achieve department set goals for excellence in quality review.
  • Provides cross-divisional support through quality review of T&D documents and other nontraditional clinical documents.
  • Leads resolution of discrepant findings with Submission Team or author, including documenting actions, verifying implementation of findings and archiving results (if appropriate).  Works cross functionally to continuously improve processes

About you

Qualifications

  • PhD or Masters degree in English/Life Sciences, Bachelors degree with at least 5 years of experience
  • 5 years in the pharmaceutical or medical industry with at least 2 years in Medical Writing
  • Proficient in Microsoft Office, Documentum, Hyperlinking and Bookmarking

Summary

  • Vacancy number: PUB211033
  • Location: Troy
  • Market: Life Sciences & Health Care
  • hours per week: 35
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of Expertise: Clinical
  • Closing date: Friday, June 21, 2019
Apply now

Feel free to contact

HD

Haley Davies

Account manager Brunel Canada Toronto

+1 416 244 2402

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