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Manager, Medical Writing

Job Description
Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a \"Global Pharma Innovator with Competitive Advantage in Oncology,\" Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

The Manager QC & Editing's primary responsibilities will be resourcing the Medical Writing QC workload and working with more Medical Writing staff to produce QC/editing guidelines, checklists, and SOPs that follow regulatory guidelines. The role is responsible for ensuring adherence to procedures and training of staff. The incumbent will work independently as a QC/Editor for documents such as, CSRs, Protocols, Protocol amendments, IBs, and Regulatory Clinical Summaries in a variety of therapeutic areas.

Responsibilities

  • Responsible for tracking all Medical Writing documents, analyzing Medical Writing editing needs, and distributing QC/editing work appropriately among department members & external consultants/vendors.
  • Works with Management to set the standards for department guidelines, templates, timelines and SOPs, ensuring compliance with applicable regulatory guidance, industry standards, and company Style Guide.
  • Perform edit checks, including spelling/grammar, consistency, correct template use and section content for Clinical Study Protocols/Amendments, Clinical Study Reports, Investigator's Brochures, Clinical Summary Documents, Other documents, as needed
  • Perform QC checks, including verifying consistency between hand-generated in-text tables and source tables, and between in-text numbers/ statements and source tables; ensuring consistency between sections; and verifying reference, table, figure, and listing citations on Clinical Study Protocols/Amendments, Clinical Study Reports, Investigator's Brochures, Clinical Summaries, and Other documents as needed.



Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)Bachelor's Degree preferred

Experience Qualifications

  • 4 or More Years relevant pharmaceutical/biotech/healthcare industry experience. preferred
  • Direct experience editing clinical study reports, clinical protocols, clinical protocol amendments, IBs, IB updates, and clinical summaries for NDA/BLA/MAA, etc. preferred
  • Understanding of general document content for each clinical document type, how the individual document types fit into a filing and feed from one to the next, and how to message appropriately across the clinical documents in a filing. preferred
  • Good working knowledge of MS WORD and Adobe Acrobat preferred


Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Medical Writing

Bernards, NJ
Full Time

Published on 11/26/2021

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