Associate Director, Cell Therapy CMC Technical Writing

Main Location
New York City, NY, United States
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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.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

The Associate Director of Cell Therapy (CT) CMC Technical Writing plays a critical role in the development of our technical writing capabilities. In partnership with CTDO functional areas and Global Regulatory Sciences-CMC (GRS-CMC), the Associate Director builds and leads the central technical writing team to support the integrated asset portfolio, serving as a bridge between the technical teams and GRS-CMC for end to end regulatory filings. Core responsibilities include driving the end to end technical writing support business process, facilitating a portfolio view across submissions, and management of direct reports (technical writers and document specialists), contractors, and external consulting partners.

In this role, the Associate Director of CT CMC Technical Writing will partner closely with leaders in CTDO and GRS-CMC to deliver high quality regulatory submission documents. The role ensures the technical documentation strategy & approaches evolve as needed based on learnings across the portfolio. Therefore, it is critical that the candidate effectively engages a matrixed team of internal and external partners to ensure organizational alignment.

DUTIES AND RESPONSIBILITIES:

  • Hire and supervise a group of FTEs and/or contractors as needed to support execution on portfolio. Develop staffing models and manage flexible resource allocation across internal and external resources.
  • Develop business processes to create value added technical writing support in the near term while building capability for long term vision
  • Support E2E regulatory submissions from INDs, briefing books, license applications to post approval submissions
  • Develop trainings, templates and guidelines for regulatory and technical documents as delivered by technical functions
  • Drive collaboration and efficient execution across technical functions on timely & high quality delivery of technical documents for regulatory submissions
  • Work effectively with cross functional project teams and coordinate work within own function efficiently;
  • Remain current on GMP regulations, regulatory agency trends, and industry practices.
  • Facilitate timely and effective communication within and between CTDO functions and program matrix  teams, including as member of appropriate matrix teams as needed.

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:

  • BA/BS degree required; seeking balanced combination of technical and regulatory CMC experience
  • 10 plus years direct professional experience in CMC development in life sciences, biopharmaceuticals; strong understanding of biopharma drug development and regulatory approval process
  • Strong technical writing skills and prior experience with supporting regulatory filings across multiple jurisdictions
  • Detail oriented, organized, with ability to influence others and a customer-focused mindset
  • Demonstrated ability to work through people, delegation; experience with matrix leadership and direct line management a plus
  • Good understanding of biotech/cell & gene therapy regulations essential (ICH and other governing documents US and Global)
  • Comfort in agile environment; capable of bringing structure to vaguely defined problems while using creative yet pragmatic problem-solving approaches
  • Highly effective written and verbal communication skills; strong presentation, facilitation, and stakeholder management skills
  • Demonstrated experience in CMC development and implementation of business processes that enhance organizational sustainability.
  • Demonstrated ability to coach team leaders in navigating the complexities of a cross-functional, matrixed organization that is dynamic and rapidly evolving.  
  • Inclusive interpersonal skills; ability to build relationships, influence, and drive organizational change

If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

BMSCART

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.

Mission
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Associate Director, Cell Therapy CMC Technical Writing
Bristol Myers Squibb