Program Manager Medical Writing

Program Manager Medical Writing

8-11 years
Not Specified

Job Description

The purpose of the role is to lead client ICF writing/review programs with high visibility among internal teams and external clients. The Program Manager Medical Writing is responsible to maintain high level of client engagement and relationship management. The role ensures the timely delivery and the quality of multiple medical writing deliverables, primarily ICFs.
Main Responsibilities:
  • Development of project timelines, standards, budgets, forecasts and contract modifications for assigned projects
  • Preparation of presentations, development and review of proposal texts to support the Business Development and Senior management on securing new business at program level
  • Escalation point of contact for assigned programs - evaluation and resolution of risks that could impact the project quality, budget or timelines
  • Ensures compliance with quality processes and requirements for assigned programs both within and between documents within a project.
  • Development, review and management of performance metrics for the assigned projects
  • Training of medical writers on processes and technical aspects of program management.
  • Supports individual writers with project needs.

Job Qualification
  • Bachelor degree in a scientific discipline
  • Previous experience that provides the knowledge, skills and abilities to perform the job (8+ years)
  • Experience in managing and directing complex medical writing projects
  • Experience in the pharma/CRO industry

Knowledge, Skills and Abilities:
  • Solid program management skills
  • Experience with regulatory document management
  • Experience with ICF is an advantage
  • Extensive knowledge of global, regional, national and other document development guidelines
  • In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
  • Excellent interpersonal, oral and written communication, and presentation skills
  • Excellent negotiation skills
  • Self-motivated and adaptable
  • Excellent judgment high degree of independence in decision making and problem solving
  • Capable of mentoring and leading junior level staff

If you have the required expertise, and you would like to expand your experience as a Program Manager Medical Writing, submit your CV.

Job Details

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