Posted 23 days ago

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 Technical Writing and Document management (TDM) function is responsible for delivering CMC documentation (Dossier and supporting documents) to support regulatory strategy for Cell therapy portfolio from early stage through life cycle management. 

The Senior Specialist, TDM is responsible for preparing CMC elements of regulatory filings under a Sr. Technical Writer’s guidance in the clinical and commercial space for the cell therapy portfolio.

This role requires effective collaboration across technical functions to deliver on accelerated timelines for submissions. The candidate is expected to have an understanding of regulatory guidelines and product development experience. The position interfaces with subject matter experts in Process Development, Manufacturing Sciences and Technology, Product development, Operations, Analytical, Quality and Regulatory Sciences. The successful candidate will work effectively in cross functional project teams and independently to accomplish company goals.

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 scientific input 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.
  • Support and implement continuous process improvement ideas and initiatives.
  • Coordinate with CMC matrix team members to ensure timely submissions (Edited)
  • Support the logistical process and detailed timeline for scientific/ regulatory content creation for clinical, commercial, and life-cycle CMC regulatory submissions and responses to health authority questions.
  • Support dossier creation and system compliance for regulatory submissions
  • Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.

Leadership

  • Works independently under the guidance of Sr. Technical Writers and collaborates with other groups
  • Embody curiosity and growth mindset.
  • Trains others on procedures as appropriate. 

Qualifications

  • Bachelors degree required advanced degree is preferred.
  • 3-7 years of relevant CMC development (analytical/ process development/ product development/ quality or equivalent) / CMC-RA experience.
  • Demonstrated ability to critically evaluate data from various CMC functions.
  • Excellent organizational and communication skills are required along with proficient navigation of electronic systems.
  • Experience with regulatory publishing software is preferred.
  • Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
  • Possess strong interpersonal skills and demonstrate ability to effectively interact with business functions.

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. 

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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

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Senior Specialist, Technical Writing and Document Management - Cell Therapy