Sr. Manager, Global Regulatory Medical Writing – Remote


Penfield Search Partners

Contact: Linda Aronova –

Job Description: As a Senior Manager, in Global Regulatory Medical Writing, you will write and edit clinical regulatory documents, including submission summaries and other complex documents, provide intermediate-level oversight and guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations.

Travel Requirements: International and Domestic Travel

Essential Duties & Responsibilities:

  • Primarily work on the product/program level
  • Write and edit clinical regulatory documents (all types)
  • Possible to have direct reports; likely to oversee contingent workers and/or vendors; likely to provide training to others; and analyze needs to manage resources
  • Offer leadership and fundamental accountability, provide strategic supervision, and planning assistance for clinical regulatory documents
  • Ensure that documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
  • Participate in the preparation/revision of document templates


  • Education/Experience: PhD or PharmD in life sciences (or other related field) with a minimum of 5 years of experience, or  Master’s degree in life sciences (or other related field) with minimum of 7 years of experience
  • Mastery of Microsoft (MW) Word
  • Considered a competent manager with advanced regulatory medical writing expertise
  • Possess advanced writing and editing skills and proficiency in using software, templates and other electronic formats
  • Knowledgeable of government regulations pertaining to drug development, guidelines for document submissions, varied therapeutic areas, and statistical concepts
  • Possess excellent written and oral communication skills
  • Able to contribute to strategy under moderate supervision
  • Able to tackle difficult problems; identify solutions and lead decisions to resolution
  • Influence communication toward common understanding and actionable results
  • Lead process development and improvement
  • Manage and deliver assignments with quality and within timelines
  • Provide input for budget planning


Tagged as: Sr. Manager, Global Regulatory Medical Writing - Remote