Senior Manager of Medical Writing

Senior Manager of Medical Writing

One of Meet's top biopharmaceutical clients has come to us with an exclusive new search for an accomplished Senior Manager of Medical Writing. This is a great opportunity to work with exciting products that sit at various life cycle stages and lead the completion of clinical/regulatory documents in support of their extensive development pipeline. As a fully remote role, this is a wonderful opportunity for someone looking for a flexible role in a leading sponsor.

Role Responsibilities:

• Lead submission level documents at the project manager level (BLA/IND/NDA), as well as handle all components of writing clinical regulatory documents (CSRs, Protocols, IBs)
• Assure documents are in accordance with ICH as well as other regulatory guidelines
• Convey data in a consistent and concise manner in line with the clinical regulatory documents
• Mentor junior writers that are within the team, navigating team dynamics and driving and maintaining strict timelines as a project lead
• Arrange and lead team review meetings during the course of project progression

Required Skills:

· Minimum of 8 years in the pharmaceutical industry, either CRO or Sponsored

· 5+ years of experience writing clinical and regulatory documents; module summaries experience required

· Ability to lead key regulatory documents such as CSRs, IBs, CTD Modules, and BLAs/NDAs/MAAs through all phases

· Advanced Degree in Life Sciences, PhD preferred, Professional Medical Writing certification (e.g., AMWA, EMWA, RAPS)

Contact:

Full job description and company details are available upon application.

This position is being dealt with by Payton Baker at Meet Recruitment, call on +1 312-878-1924 or email directly at payton@peoplewithchemistry.com to discuss further and in confidence.

You can find out more about Payton & Meet at www.peoplewithchemistry.com