Senior Director, Medical Writing

Contact: Matt Azarva
Phone: (215) 830-9202

Position Overview

Our client is a private biopharmaceutical company advancing a pipeline of potential best-in-class therapies for neurodegenerative diseases.

This role will report to the VP/SVP of Regulatory Affairs and Medical Writing, the Senior Director Medical Writing will provide strong technical expertise in Medical Writing and will build and supervise the medical writing team within the company.

Key Responsibilities:

  • Assesses Medical Writing needs throughout the regulatory, clinical, and nonclinical groups. Tracks, coordinates and communicates needs and solutions internally.
  • Manages day-to-day medical writing team operations.
  • Manages resources, including contractors, within the teams with regards to company templates, standards, and processes.
  • Critically review documents produced by external writers for scientific content and alignment with company position, clarity, accuracy, and consistency.
  • Assist clinical/regulatory teams with managing documents through the review process and the approval process.
  • Provides medical writing support as needed for programs by hands-on writing of protocols, IBs, INDs, and other clinical/regulatory documents.
  • Assess and develop new processes to facilitate medical writing capabilities internally as well as working with external providers.
  • Provides training and professional development to subordinate staff.
  • Position is essential to the company to meet key project objectives, including planning, evaluating and managing vendors.

Key Requirements:

  • At least 10 years medical writing experience.
  • Minimum BA/BS degree in life sciences; Master’s degree is preferred.

Boston/Flexible/Remote

Location(s)

Remote

If interested, please send a MS Word version of your resume to [email protected]

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