CMC Technical Writer

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

The CMC Technical Writer is responsible for managing and preparing Market Applications and/or post-approval regulatory submissions for small molecule and biologic projects.

This role requires effective collaboration across technical functions to deliver on timelines for submissions. The candidate is expected to have a thorough understanding of regulatory guidelines. The position routinely interfaces with experts in Manufacturing Sciences and Technology, Operations, Analytical Sciences, Quality, and Regulatory Sciences. The successful candidate will work effectively in cross-functional project teams and also independently to accomplish company goals.

Duties & Responsibilities

• Author independently CMC elements of regulatory filings.

• Provide technical writing expertise to ensure CMC submissions meet regulatory requirements and health authority expectations.

• Develop authoring plans and strategic approaches to filings with cross-functional teams.

• Carry out integrated review process for documents and lead the finalization of drafts for next phase review.

• Functional representation in collaboration with Regulatory CMC teams and technical experts, creates final drafts of Regulatory documents for submission to Regulatory and onwards to global Health Authorities (HAs).

• Critically review documents for consistency and quality.

• Promote standardization of submission process within organization.

• Develop, improve, and implement templates for CMC filings.

• Must possess the ability to support multiple projects and to prioritize work independently.

• Documents include: BLA, MAA, NDA, Briefing Documents, PAS, CBE-0, CBE-30, Variations, HA Queries etc.

Qualifications

• Bachelor’s degree or equivalent in relevant discipline with a minimum of 5 - 7 years relevant experience, Master’s degree with 2 - 4 years relevant experience, or PhD. Time spent in advanced degree programs may be considered as equivalent relevant experience.

• Must have a working knowledge of regulatory submissions. Knowledge of ICH and other governing documents (US and global).

• The ability to handle multiple tasks independently and manage competing priorities.

• Excellent time management, organizational, and communication skills are required along with proficient navigation of electronic systems.

• Project management experience preferred.

Leadership

• Work independently and collaborate with other teams.

• Deliver results in line with project and team objectives.

• Lead technical projects and train others as appropriate.

The starting compensation for this job is a range from $87,000 to $110,000, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed.

Final individual compensation will be decided based on demonstrated experience. For more on benefits, please visit our BMS Careers Site. Eligibility for specific benefits listed on our BMS Careers site may vary based on the job and location.

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.