CMC Writing & Operations Senior ManagerDirector
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Job Summary
Trilogy Writing & Consulting an Indegene Company has an immediate opening for a CMC Writing & Operations Senior Manager/ DirectorWe are seeking someone to lead build and oversee a growing CMC writing team. This leader willbe responsible forboth internal team management and client-facing strategic CMC consulting. The ideal candidate brings hands-on CMCexpertise including preparation of CMC documentation as well as confidence poise and the ability to lead client engagements. This role will also help shape best practices for CMC content generated via our AI platform collaborating closely with clients and internal teams as we advance our CMC capabilities.
You will be responsible for:
- Leadership and Team Building:
Lead mentor and expandaglobalteam of CMC medical writers/experts.Establish team structure processes and operational standards for a newly built CMC tothe developmentof CMC operating models processes and procedural documentation.
- Client-Facing Responsibilities:
Represent the CMC team as a seniorsubject matter expertin meetings with clients including regulatory strategy discussions and project expert input into solutions assumptions demand estimates and costing for client in/leadpitch meetings.
- CMC Operations/Writing & Quality Oversight:Oversee quality for CMC deliverables prepared by the writing quality timelines and compliance with performance metrics and contractual specifications. Contribute hands-on writing or review as needed particularly for high priority clients or complex CMC documents.
- Supporting AI development:Serve as the strategic advisor on AI-generated CMC outputs from development of the CMC outputs by generating and reviewing CMC outputs from our medical writing platform and working with the AI development team to improve the quality of the outputs.
- Cross-functional Leadershipand Collaboration:
Work with Regulatory Strategy OperationsManufacturingGo to Market team and AI platform teams to ensure unified delivery across closely withthe Regulatoryleadershipteam to further expand the team and the business.
Musthave:
- Minimum of aBachelors degree in Chemistry Pharmacy or a relevant scientific discipline.
- Extensive experience in CMCoperationswritingandastrong familiarity with regulatory expectations across development stages(new products as well as life-cycle management of marketed products).
- Proven leadership experiencepreferably at the Manager Senior Manageror equivalent levelwithin pharmaceutical or biotech organizations.
- Demonstrated experiencepresenting scientific datato internal leadership and/or external partners.
- Ability tooperateconfidently as a consultant-levelsubject matter expertand interact directly with clients.
- Track recordof managing or collaborating withmanufacturing sites QC/QA teamsCROsand othercross-functionalstakeholders.
- Strong communicationskills and comfort with both strategic and operational aspects of CMC projects.
- Strong business acumen and financial understanding of various business models.
Goodtohave:
- Experience shaping or evaluating AI-assisted document workflows and outputs.
- Knowledge of building new service lines or operational structures within regulatory writing.
- Ability to work in fast-paced ambiguous or start-up-like environments while shaping new capabilities.
- Experience working with international team members.
Perks:
- Competitive base salary (the salary may vary based on experience level region and the Companys compensation practices)
- Annual bonusopportunity
- Private healthcare life assurance and income protection
- A generous allowance of paid time off (vacation holiday birthday illness)
- Continuous personal and professional development opportunities
- Other fun and exciting events thatencourage team bonding and development
EQUAL OPPORTUNITY
Indegeneis an Equal Opportunity Employer committed to fostering a culture of inclusion diversity and respect. We do not discriminate against any individualon the basis ofrace colour religion or belief sex sexual orientation gender identity or expression age national or ethnic origin disability marital or parental status or any other characteristic protected under applicable laws. All employment decisions including recruitment hiring training compensation promotion and separation are made based on business needs individual merit and qualifications.
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Director
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About Company
Partners for Medical Writing - Trilogy Writing & Consulting GmbH - providing all necessary regulatory documentation in support of your clinical development.
