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Position: Global Regulatory Writing Manager
Location: Hyderabad, India
Experience: 3+ years
Qualification:

  • Doctorate degree OR
  • Master’s degree with 3 years of experience OR
  • Bachelor’s degree with 5 years of experience
    Job ID: R-202300
    Application Deadline: 20th January 2025

Role Description

The Global Regulatory Writing Manager is responsible for authoring and securing approval for scientific and regulatory submission documents that meet global standards. The position involves collaboration with cross-functional teams, management of writing activities for regulatory submissions, and mentoring junior writers.

Responsibilities:

  • Create regulatory documents, including clinical study reports, protocols, investigator brochures, and eCTD modules.
  • Review and approve documents as per SOPs.
  • Oversee writing activities for regulatory submissions under supervision.
  • Participate in team activities such as Global Regulatory Plans and Evidence Generation.
  • Mentor junior writers and support departmental initiatives.
  • Manage document timelines in collaboration with teams.

Candidate Profile:

  • Proficiency in scientific and technical writing for regulatory documents.
  • Strong understanding of ICH, GCP guidelines, and clinical development processes.
  • Expertise with Microsoft Office tools and time/project management skills.
  • Exceptional communication and leadership abilities.

Application Link

Amgen Hiring Global Regulatory Writing Manager