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CMC Technical Writer, New Brunswick, New Jersey

CategoryMedical and Regulatory Affairs
Job typeFull-Time
CountryUnited States
StateNew Jersey
CityNew Brunswick

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.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Position Summary

The CMC Technical Writer is responsible for managing and preparing biologics regulatory submissions in the clinical and commercial space.

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 Development, 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.

Detailed Position Responsibilities

  • Author independently CMC elements of regulatory filings.
  • Carry out integrated review process for documents and leads the finalization of drafts for next phase review.
  • Develop, improve and implement templates for CMC filings.
  • Develop authoring plans and strategic approaches to filings with cross-functional teams.
  • Plan the authoring and review of CMC Regulatory documents.
  • 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).
  • 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, IND, IMPD, Briefing Documents, PAS, CBE-0, CBE-30, Variations, HA Queries etc.
  • Critically review documents for consistency and quality.
  • Promote standardization of submission process within organization.
  • Works independently and collaborates with other teams.
  • Delivers results in line with project and team objectives.
  • Leads technical projects and trains others as appropriate.

Desired Experience

  • Bachelor's 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 for pre and post filings.
  • 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.
EmployerBristol-Myers Squibb

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