Manager Medical Writing

  • Location: Berwyn, Pennsylvania
  • Type: Direct Hire
  • Job #17619

Manager, Clinical Writing
Location: Berwyn, PA
Hybrid schedule

Are you passionate about the life sciences and would love to be part of advancing medicine in the neurosciences?  Are you organized, have writing experience and love the details?  This may be for you!
You will have the opportunity to work alongside energetic and passionate people that believe in collaboration and open feedback. A casual culture, with serious and ambitious goals. A startup environment that gives your aspirations and dreams a real chance to change status quo. An opportunity to develop cross-functional skills among different departments (Science, business, manufacturing, regulatory, etc.).
Performance Objectives:

  • Responsible for the development of high-quality clinical documents submitted to Regulatory Authorities (e.g. FDA and EMA) including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and clinical summary sections in support of regulatory submissions.
  • Collaborate with clinical development and clinical operation to ensure alignment with program objectives.
  • Be an active member of a dynamic and fast-moving company.
  • Assist with development and implementation of Medical Writing processes improvement in line with SOPs.

Education/Certification Requirements:

  • Bachelor’s Degree in life science, health-related or pharmaceutical field with advanced degrees in life science preferred but not required
  • CNS experience required
  • At least 10 years relevant experience.
  • Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations.
  • Knowledge of template development, document management systems and requirements.

For immediate consideration, email and mention Job#17619