Job Description

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.

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 - our Scientific Writing department is passionate about making an impact on the lives of patients with serious diseases. We apply our individual talents and ideas so that we can learn and grow together in pursuit of the Bristol Myers Squibb vision. As valued team contributors to nonclinical, clinical, safety, and regulatory documents, our support both strategically and scientifically flows with drug development throughout the life cycle of our medicines. In pursuit of our commitment to bringing these important medicines to patients, we work with a sense of urgency in the preparation of fit-for-purpose, message-driven documentation meeting both quality and compliance standards.

Key Responsibilities

• Lead writing team in document prototyping and preparation processes to ensure:
• (i) coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation, and
• (ii) appropriate prioritization of critical versus non-critical path activities.
• Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
• Drive the development and manage the implementation of regulatory documentation strategy to meet time and quality performance goals for filing regulatory dossiers as planned by Development Teams.
• Coordinate documentation activities of multi-functional authors, reviewers, and approvers; manage the document review process to maximize speed and quality on behalf of the assigned development team(s).
• Ensure documentation strategy is integrated to support filings, approvals, and/or other regulatory commitments in the intended key markets.
• Contribute to the development of effective documentation processes and standards; implement the processes to support goals of assigned development team(s) and ensure maintenance of documentation standards.
• Critically review project-specific model documents, key data texts and displays during dossier prototype creation and facilitate reaching a consensus at key findings/ final document review meeting.
• Influence the assigned development team(s) in tracking milestone activities and proactively identify opportunities and threats in terms of dossier documentation activities, particularly the ones with a potential to impact the dossier quality or timelines.
• In conjunction with the team members, manage and coordinate responses to dossier-related health authority questions.
• In conjunction with appropriate disciplines, identify and ensure management of external documentation support when required.
• Identify opportunities to participate / influence regulatory policy and climate with respect to documentation and dossier presentation in support of project goals and BMS preferences.
• Apply knowledge of internal and external guidances in providing feedback to Development Teams on issues related to regulatory documentation.

Qualifications & Experience

• PharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with a minimum of 10 years in pharmaceutical regulatory documentation. Prior regulatory documentation leadership in the development and approval of new drug applications/dossiers is preferred. All PhD in biological sciences and PharmD candidates are considered.
• A proven record in managing a large group/project team with solid behaviors in cross-functional collaboration and communication.
• Significant experience in writing high-quality regulatory documentation, including high-level summary documents (preferably clinical).
• Experience in managing project teams and process workflows, and exhibits solid behaviors in cross-functional collaboration and communication.
• Experience in working in a rapidly changing environment where decisiveness, adaptability, and communication are critical to success.
• Experience in mentoring and professional development of junior colleagues in a group.
• Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities
• Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team.
• Experience in the areas of state of the art documentation processes and technology.
• Please note the position is not a remote working opportunity and is based in NJ.

Why You Should Apply

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.

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.