Hiring company: BMS
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.
Job Responsibilities:
- Prepare under supervision CMC elements of regulatory filings.
- Supports integrated review process for authored sections. Support the operation of the review process and creates updated draft for next phase review.
- Participate in initiatives (creation of templates) involved with regulatory filings.
- Support the logistical process for regulatory submissions while interfacing across the BMS network as needed.
- Assist in the facilitation of authoring, review, verification and submission-ready compliance for the finalization of filings as needed.
- Participation on various cross-functional project teams, interactions with Technical Operations and GRS-CMC staff at different BMS sites and other key partners both internal and external to the company are necessary.
- Must possess the ability to support multiple projects.
- Work in a team environment and foster teambuilding for the improvement of processes and enhancement of productivity to align with key business drivers.
- Demonstrate commitment to excellence and bring a high energy level to daily activities as well as involve periods of high intensity work under tight timelines.
Leadership:
- Works under supervision and collaborates with other groups.
Qualifications:
- BS with 2-5 years of pharmaceutical experience or MS degree. Advanced degree is an asset.
- Excellent organizational and communication skills are required along with proficient navigation of electronic systems.
- Proven experience with regulatory publishing software is required along with proficiency in compliance ready standards for final publication.
- Must have a working knowledge of regulatory submissions.
- Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
- Possess strong interpersonal skills and demonstrates ability to effectively interact with business functions.
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.