Manager, Medical Writing

Job Summary Senior Manager, Medical Writing – Top 10 Clinical Research Organization – US/CAN (remote) Meet is a proud partner to one of the top 10 Clinical Research Organization companies headquartered in North Carolina, on their search for a Senior Manager, Medical Writing. The company has a solid reputation within the Biotech space. The company has offices across the US and this role is fully remote.

Job Overview - Work as medical writing lead on earliest stages of development.

• Oversees project progress for direct reports and provides input, support, and constructive feedback, as appropriate.
• Development of Regulatory submissions; CSRs, protocols, IBs, DSURs, regulatory responses, Module 2 summary documents for Investigational New Drug (IND) applications and new drug applications (NDAs), and Integrated Summaries of Safety and Efficacy (ISS and ISE).
• Prepares, reviews, and maintains documents that enforce standardization of procedures and improvement of quality (Standard Operating Procedures, Working Guidelines, Associated Documents, Manuals, Instructions).

Required

Skills Required - 5 years of medical/scientific regulatory writing experience

• Background from either the pharmaceutical industry, academia, medical communications agency required
• 2 years of supervisory experience
• Expertise in medical writing for IND/NDA/BLA/MAA/505(b)(2) and other regulatory documentation.

Contact Details Full job description and company details are available upon application, apply below. If interested in this position, contact Brandon Weber at Meet, email directly at Brandon@peoplewithchemistry.com to discuss further and in confidence.