Medical Writing Operations Senior Manager

Remote

Job Description

General Summary:

The Medical Writing Operations Senior Manager is responsible for day to-day technical operations within the Medical Writing Associates group. The Senior Manager focuses on standardizing and improving the QC review process to ensure consistency and reliability in the QC of Medical Writing (MW) documents. The Senior Manager applies technical expertise to develop solutions to technical and operational problems and oversees the development, implementation, and maintenance of QC processes and standards for Medical Writing.

Key Duties and Responsibilities:

  • Implements and manages QC audit processes
  • Represents MW on cross functional teams, including those related to document QC, formatting, and electronic submissions
  • Proactively solves technical and operational problems within role area and identifies areas for process improvements
  • Participates in and provides technical feedback for MW processes
  • Maintains a high level of knowledge related to current developments in the field, including pharmaceutical regulations pertaining to documentation for regulatory submissions
  • Applies technical and analytical skills and recommends changes to troubleshoot systems or processes
  • Provides expertise to QC project scheduling as needed
  • Designs training plans, such as a QC and standards training plan for entry writers
  • Prepares and delivers effective presentations for internal and external audiences, as needed
  • Contributes to the medical writing priorities for clinical studies, serving as a Medical Communication Scientist as needed

Knowledge and Skills:

  • Demonstrates strong oral and written communication skills
  • Knowledgeable of processes behind hiring decisions
  • Keeps abreast of relevant technology, M1D regulatory initiatives that relate to clinical regulatory documents, and is able to make intelligent recommendations regarding new technologies and methodologies
  • Contributes to and supports short- and long term strategic direction for teams or projects
  • Successfully leads/influences activities within Medical Writing and cross-functionally
  • Seeks out and plans technical direction and promotes technological innovation

Education and Experience:

  • Master’s Degree (or equivalent degree) and 6+ years relevant work experience
  • Or, Bachelor’s Degree and 8+ years relevant work experience

Related Jobs