Manager, Document Management
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.
Functional Area Description
The Worldwide Patient Safety (WWPS) group is responsible for ensuring the safety of our medicines. WWPS pharmacovigilance and pharmacoepidemiology deliverables include single case and aggregate safety monitoring, safety reporting, contributing to benefit-risk assessment, risk management planning and strategy, execution of certain postmarketing commitments, and ensuring compliance with global regulatory requirements.
The Manager of Document Management reports directly to the Director, Local Risk Management Plan (RMP) Development Lead and will be responsible for overall coordination, project management and process management related to regulatory RMP and Risk Evaluation and Mitigation Strategies (REMS) submission activities, REMS Assessments Reports and Epidemiology protocols and related submission documents with the provision for on-time and high quality Health Authority (HA) and BMS compliant submission documents for all countries worldwide, including the U.S.
This individual contributor will serve as a liaison within Global Risk Management (GRM) between Local Market Patient Safety, REMS Strategy Leads, and REMS Committee Review team, Epidemiology team members, and other related cross functional teams. This role will direct external vendors to support REMS documents, Risk Management Plans, and Epidemiology protocols.
Responsibilities will include, but are not limited to the following:
Risk Management and Epidemiology Regulatory Submissions Coordination, Project and Process Management
Manage the development and updates to Risk Management regulatory submission documentation, including REMS, Risk Management Plans (i.e., global, and, local RMPs and Annexes) and communications for Health Agency submissions
Create timelines for submission document development activities with the project submission lead
Schedule, prepare for, and lead kick off meetings for submissions in collaboration with subject matter experts/project leads including scope and rationale, timelines, and document contributors. Support template development for submission documents
Direct vendors to assign resources and ensure understanding of roles, deliverables, and timelines.
Maintain submissions tracker and ensure projects deliverables are on track
Collaborate with external vendors to assign resources to support submission projects.
Organize and appropriately document (within internal databases) the formal internal review process for Risk Management regulatory document submissions to ensure the integrity and compliance of regulatory submissions are maintained
Liaise with internal multidisciplinary stakeholders (i.e., Regulatory Affairs, Regulatory Operations, Patient Safety and local affiliates) to keep track of and ensure capture of updates within risk management submissions
Provides project management support for the creation of supplementary materials to support Risk Management regulatory submissions
Support live meetings with TA Leads and local affiliates (comment resolution meetings, status meetings, etc.)
Learn database systems used to support submissions, in order to conduct submission activities and provide guidance and leadership to cross functional teams and vendors
Utilize project management skills to ensure high quality deliverables are provided in a timely manner
Health Authority Risk Management Deliverables
Provide overall project management support to ensure appropriate timelines are developed to meet submission deadlines and to ensure high quality deliverables.
Support the development of high-quality, on-time Health Authority deliverables such as RMPs, REMS Assessment Reports, FDA response inquiries, ad hoc survey results, etc.
Ensure the coordination and execution of timely and efficient internal review and approvals of Risk Management regulatory report deliverables
Collaborate with other internal departments to obtain information and data as needed to support the creation and development of submission deliverables as required
Responsible for the quality of output documents and ensures content meets appropriate editorial standards (style, formatting, document requirements, etc.)
External Risk Management/REMS Pharmaceutical and Regulatory Environment Monitoring
Demonstrate expertise in the understanding of the complexity of pharmacovigilance-related regulatory guidance/legal requirements and contextual agility to accommodate customizations where country-specific requirements apply.
Data analysis and management with Reporting
Obtain, analyze, and summarize submissions data to provide data-driven conclusions and make appropriate recommendations/solutions
Provide monthly reports on Risk Management and Epidemiology reporting activities
Contribute to and support the development, implementation, and optimization of various risk management tracking tools, e.g., Veeva Vault, and SharePoint trackers and CARA/PRISM for authoring and publishing
Contribute and represent GRM Submissions and Operational Excellence team on cross functional projects with GRM (i.e., Strategy, Operations, Quality, Technology, etc.)with
Contribute to and support procedure document updates (i.e., Standard Operation Procedures, Work Practices, etc.) as required
Actively participate in International PV Meetings, as required
Propose creative solutions for continuous improvements to local market (LM) processes, core activities, and risk management (RM) systems
Provide back-up support for other team members as required to ensure continuity of projects and submission deliverables.
Support internal audit and regulatory inspection activities
Monitor GRM and RM Submissions mailbox
Assist with ad hoc projects and additional tasks as assigned
BS/BA required, advanced degree in healthcare science, public health, or applicable fields, a plus
5 years previous experience in Pharmaceutical Industry (REMS Operations, EU-RMPs, Medical Communications, Regulatory, or Safety/Pharmacovigilance or relevant disciplines)
Have advanced skills in MS Word, Excel, MS Project Management and PowerPoint.
Medical/REMS document preparation experience, a highly desired
REMS and European Union (EU)-RMP knowledge and experience, highly desired
Experienced in project management
Experienced in vendor management
Ability to independently manage multiple projects with accountability and excellent work ethic
Proven skills in collaboration with cross-functional teams and in a team environment
Excellent and effective verbal and written communication skills with the ability to interface with Risk Management Leadership team, interdisciplinary project teams, and external vendors
Acute attention to detail. Adaptive, resilient, and nimble character, yet firm and sturdy in conviction and ethics
Highly strategic and proactively recognizes problems and foresees opportunities with a tendency to act with a solutions-driven attitude
Gradual ability to analyze Risk Management operational data and in turn recommend strategies, and prepare written reports and presentations
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.
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