CMC Writing & Operations Senior Manager/Director - Remote

Overview

Trilogy Writing & Consulting, an Indegene Company, is seeking a CMC Writing & Operations Senior Manager/Director to lead, build, and oversee a growing CMC writing team, responsible for internal team management and client-facing strategic CMC consulting.

In Short

• Lead and mentor a global team of CMC medical writers.
• Establish team structure and operational standards.
• Represent the CMC team in client meetings.
• Oversee quality for CMC deliverables.
• Serve as a strategic advisor on AI-generated CMC outputs.
• Work with cross-functional teams to ensure unified delivery.
• Manage client engagements and project scoping.
• Contribute hands-on writing or review as needed.
• Drive development of CMC outputs from the AI platform.
• Collaborate with regulatory leadership to expand the business.

Requirements

• Bachelor’s degree in Chemistry, Pharmacy, or relevant scientific discipline.
• Extensive experience in CMC operations and writing.
• Proven leadership experience in pharmaceutical or biotech organizations.
• Experience presenting scientific data to leadership and partners.
• Ability to operate as a subject matter expert and interact with clients.
• Track record of managing collaborations with cross-functional stakeholders.
• Strong communication skills in strategic and operational aspects.
• Business acumen and understanding of various business models.

Benefits

• Competitive base salary.
• Annual bonus opportunity.
• Private healthcare, life assurance, and income protection.
• Generous paid time off allowance.
• Continuous personal and professional development opportunities.
• Team bonding and development events.