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Senior Director / Executive Director Medical Writing

๐Ÿ•’ 18 days ago
PharmacovigilanceMedical WritingLeadershipCompliance

๐Ÿ“œ Description

  • Drive quality, compliance, inspection readiness, and continuous improvement initiatives.
  • Support business development activities, including proposals and client engagements.
  • Build and maintain strong client relationships, ensuring exceptional service.

๐Ÿ› ๏ธ Requirements

  • Masterโ€™s degree in life sciences or healthcare, PhD preferable
  • Extensive pharmacovigilance and PV Medical Writing experience, including leadership and people management of high-performing teams.
  • Deep knowledge of global pharmacovigilance regulations, with expertise in authoring and reviewing aggregate safety reports and PV procedures.
  • Proven experience supporting regulatory compliance, inspections, and pharmacovigilance system oversight, including QPPV or Deputy QPPV responsibilities.
  • Strong business acumen with experience supporting proposals, client engagements, and bid defense activities.
  • Excellent scientific, regulatory, and analytical capabilities, including translating complex clinical and safety data into clear, high-quality regulatory and scientific documents

โœจ Benefits

  • Lead the PV Medical Writing function, ensuring high-quality, compliant, and timely deliverables.
  • Manage and develop the PV Medical Writing team, fostering performance, engagement, and professional growth.
  • Provide strategic PV medical writing expertise and subject matter leadership to clients and project teams.
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