Manager, CMC Technical Writer (R1557132-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The CMC Technical Writer is responsible for managing and preparing Market Applications and/or post-approval regulatory submissions for small molecules and biologics. 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.
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.
Manage filings for major markets and amendments for approved products.
Documents included: BLA, MAA, NDA, Briefing Documents, PAS, CBE-0, CBE-30, Variations, HA Queries etc.
Work independently and collaborate with other teams.
Deliver results in line with project and team objectives.
Lead technical projects and train others as appropriate.
Bachelors degree or equivalent in relevant discipline with a minimum of 6 years relevant experience. Masters or PhD preferred (but not required). 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.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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