Senior Manager, CMC Technical Writing and Document Management

Posted 17 hours ago
Main Location
New York City, NY, United States
Jobs

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.

Job responsibilities

  • Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical, commercial, and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports
  • Partner with SME organizations to identify source document and negotiate delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy.
  • Provide input and scientific oversight for content generation for Quality modules 2 and 3.
  • Review and adjudicate comments, facilitates comment resolution, revises draft sections. Ensures content clarity/ consistency in messaging across dossier.
  • Represent TDM in cross-multi-functional CMC teams
  • Work with external partners (consultants, vendors, collaborators) to ensure that delivered content complies with FDA or appropriate Health Authority guidelines and regulatory strategy.
  • Support and implement continuous process improvement ideas and initiatives.
  • Coordinate with CMC matrix team leaders to ensure timely submissions.
  • Mentor and train employees on the technical writing processes.
  • Supervise and manage rotational, contingent employees and FTE.

Leadership

  • Supervise a group of FTEs and/or contractors. Plans and directs actions of the group.
  • Develop top talent with well-established succession plans
  • Lead teams and drives resources to deliver on business commitments and objectives.
  • Deliver on complex projects with minimal supervision and direction. Identifies improvement opportunities, develop relevant business processes, and takes actions to reduce cycle time.
  • Embody curiosity and growth mindset.

Qualifications

  • Requirements are dependent on hiring level
  • Educational degree in life sciences (Pharmacy, Biochemistry, Molecular Biology, Chemical engineering etc. or equivalent). Advanced degree preferred.
  • 7-10 years of relevant CMC development (analytical/ process development/ product development) / CMC-RA experience. Cell therapy development experience preferred, but not required. 
  • Must possess scientific understanding of pharmaceutical development as well as knowledge of proper interpretation of global drug development regulatory guidelines (ICH, Global) as well as iCTD requirements 
  • Demonstrated record to lead/ work in multi-functional global teams and simultaneously working on multiple projects. 
  • Demonstrated ability to critically evaluate data from various CMC functions. 
  • Outstanding verbal and writing communication skills, Attention to detail, strong planning, collaboration, negotiating, people management skills with focus on timely delivery. 
  • Proficiency in commonly used applications like Word/Excel is required. Documentum experience is preferred. 
  • May require up to 10% travel. 

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. 


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 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.

Mission
We're a community of women leveraging our connections into top companies to help underrepresented women get the roles they've always deserved. Simultaneously, we work to build truly inclusive hiring processes and environments where women can thrive and not just survive.
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Senior Manager, CMC Technical Writing and Document Management
Bristol Myers Squibb