Trilogy Writing & Consulting, an Indegene Company, has an immediate opening for a CMC Writing & Operations Senior Manager/ Director We are seeking someone to lead, build, and oversee a growing CMC writing team. This leader will be responsible for both internal team management and client-facing strategic CMC consulting. The ideal candidate brings hands-on CMC expertise, 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 expand a global team of CMC medical writers/experts. Establish team structure, processes, and operational standards for a newly built CMC capability. Contribute to the development of CMC operating models, processes, and procedural documentation.
- Client-Facing Responsibilities:
Represent the CMC team as a senior subject matter expert in meetings with clients, including regulatory strategy discussions and project scoping. Provide expert input into solutions, assumptions, demand estimates, and costing for client proposals. Participate in/lead pitch meetings.
- CMC Operations/Writing & Quality Oversight: Oversee quality for CMC deliverables prepared by the writing team. Ensure 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 the AI platform. Drive 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 Leadership and Collaboration:
Work with Regulatory Strategy, Operations, Manufacturing, Go to Market team, and AI platform teams to ensure unified delivery across projects. Coordinate closely with the Regulatory leadership team to further expand the team and the business.
Must have:
- Minimum of a Bachelor’s degree in Chemistry, Pharmacy, or a relevant scientific discipline.
- Extensive experience in CMC operations, writing, and a strong familiarity with regulatory expectations across development stages (new products as well as life-cycle management of marketed products).
- Proven leadership experience, preferably at the Manager, Senior Manager, or equivalent level, within pharmaceutical or biotech organizations.
- Demonstrated experience presenting scientific data to internal leadership and/or external partners.
- Ability to operate confidently as a consultant-level subject matter expert and interact directly with clients.
- Track record of managing or collaborating with manufacturing sites, QC/QA teams, CROs and other cross-functional stakeholders.
- Strong communication skills and comfort with both strategic and operational aspects of CMC projects.
- Strong business acumen and financial understanding of various business models.
Good to have:
- 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 Company’s compensation practices)
- Annual bonus opportunity
- 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 that encourage team bonding and development
EQUAL OPPORTUNITY
Indegene is an Equal Opportunity Employer committed to fostering a culture of inclusion, diversity, and respect. We do not discriminate against any individual on the basis of race, 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.
