Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com
Looking to jump-start your career?

We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth.

We are purpose-driven.  We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

Role: Senior Manager specializing in CMC Operations and Writing 
Education: Minimum of a Bachelor’s degree in Chemistry, Pharmacy, or a relevant scientific discipline Plus relevant Master's degree.
Experience: 16-18 years of overall 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). 
Role Purpose:
To lead, build CMC expertise, and oversee a growing CMC writing team within our Regulatory Services business. 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.
Knowledge and Skill Requirement: 
Must have: 
•    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.

Responsibilities:
•    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. 

Location Requirement:
Applicants must live in the United States or Canada and be authorized to work for any employer (we are unable to sponsor or take over sponsorship of an employment visa at this time). This position is either fully remote or hybrid remote, depending on location.

Good to have

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.

EQUAL OPPORTUNITY

Compensation & Benefits Transparency Statement

Base Salary Range: $150k-$185k

The compensation range displayed reflects the full span of pay across all of our U.S. geographic pay areas and experience levels. Your actual base salary offer will be determined based on multiple factors, including:

• Geographic Pay Area (US 1 through US 5, reflecting cost‑of‑labor differences)
• Experience & Qualifications relevant to the role
• Internal Equity alignment with employees in similar roles and levels

What This Means for You

• The minimum of the posted range represents the starting point for candidates in the lowest cost‑of‑labor pay areas (US 5).
• The maximum of the posted range represents the upper threshold for candidates in the highest cost‑of‑labor pay areas (US 1 / US 2).
• Candidates are aligned to pay areas based on their primary work location.

For Current Employees

Posted salary ranges reflect the full compensation band across all U.S. pay areas and experience levels. Your individual compensation is based on your specific pay area, hire date, performance trajectory, and internal equity. Differences between your current salary and the posted range are not indicative of a pay discrepancy. Please contact HR with any questions.

Benefits Overview

This role is eligible for a comprehensive benefits package, including medical, dental, and vision coverage; life and disability insurance; a 401(k)-retirement plan; seven (7) sick leave days, vacation paid time off, and paid holidays; all in accordance with Company plans. Specific benefits are governed by applicable plan documents.

Indegene is committed to pay equity and transparency. We regularly benchmark our compensation against market data to ensure competitive and fair pay practices across all locations.

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.