We have a terrific opportunity for a Senior Manager, Medical Writing-Neurology/CNS, with expertise in regulatory writing, to join a global pharmaceutical company leading drug development in neuroscience by combining state-of-the-art research with treatment solutions that create a positive and meaningful impact.

Awesome potential for career advancement and professional development!

Organization: Explore an opportunity to join a forward-thinking pharmaceutical company that combines breakthrough research and innovation while staying true to their values of integrity, quality, teamwork, and trust.

Culture: provides a collaborative work environment that empowers and enables their employees.

Position Focus:

• Develop PCS, protocols, and protocol amendments, often functioning as the compound lead. Lead and contribute to the writing of marketing application submission documents.
• Provide direction to other medical writing on how to apply industry and medical writing best practices.
• Contribute to process improvement across functional areas.
• Collaborate with teams to form project specific metrics that adhere with standard project metrics.

Requirements:

• Bachelor’s degree in Life Sciences, English, or other related discipline; advanced degree preferred.
• 5+ years of medical writing experience with specialization in the regulatory space including writing for submissions, IBs, NDAs, Module 2 summaries, etc.
• Therapeutic experience in Neuroscience/CNS; with experience in epilepsy, movement disorders, and neurodegenerative diseases a plus.
• Certification in Medical Writing/Regulatory Writing (RAC) desirable.

Contact: Kelly Gutradt