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.
Manager, Document Management
GRM Lead, Publishing and Support
Center of Excellence - Global Risk Management
BS/BA required 5-7 years Pharmaceutical experience in REMS Operations, Medical Communications/Medical Affairs, Regulatory, or Safety/Pharmacovigilance. REMS and Risk Management Plan experience preferred.
The Manager of Document Management reports directly to the GRM Lead of Publishing and Support and will be responsible for overall coordination, project management and process management related to regulatory RMP (Risk Management Plan) and REMS (Risk Evaluation and Mitigation Strategies) for all submissions to Health Authorities. This individual contributor will serve as a liaison within the LM Pharmacovigilance departments with major support between the U.S. REMS department and the members of the REMS Committee Review (RCR) members. This role will direct external vendors to support the REMS Modification process, Risk Management Plans and support RM data analysis.
Responsibilities will include, but are not limited to the following:
1. Risk Management Regulatory Submissions Coordination, Project and Process Management
a. Managing submission documents for REMS and RMP Health Authority submissions
b. 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
c. Liaise with internal multidisciplinary stakeholders (e.g. Regulatory Affairs, Regulatory Operations, Safety, local affiliates and Legal) to keep track of and ensure capture of updates within risk management submissions
d. Manages the creation of supplementary materials to support Risk Management regulatory submissions
e. Support live meetings with TA Leads (Review resolution meetings, status meetings, etc.)
f. Direct as requested internal and external stakeholders and vendors to create and supply the necessary components to complete the REMS submission package (risk management materials, screenshots, etc.)
g. Track and approve vendor invoices related to RMP and REMS submission activities
h. Ensure the utmost quality of risk management submission content through in-depth review of submitted documents, attention to detail, and verification of facts/changes to materials
i. Utilize project management skills to ensure high quality deliverables are provided in a timely manner
j. Facilitate kick off/periodic status meetings with U.S. REMS departments (Customer Care, Quality Operations, REMS Technology, and REMS Advisor/Training) to educate on the content of REMS modification submissions.
k. Coordinate with Regulatory Operations on REMS correspondence, modification and/or assessment submission.
2. Health Authority Risk Management Deliverables
a. Supports the authoring development process and data analysis of high-quality Health Authority deliverables such as RMP Assessment Reports, RMP related HA questions (e.g. Rapid Response Teams (RRTs) to respond to RMP-related HA questions, ensuring alignment with the Company position and strategy), ad hoc survey results, etc.
b. Ensure the coordination and execution of timely and efficient internal review and approvals of Risk Management regulatory report deliverables
c. Collaborate with other internal departments to obtain information and data as needed to support the creation and development of FDA REMS deliverables and Risk Management deliverables upon request
d. Responsible for the quality of output documents and ensures content meets appropriate editorial standards (style, formatting, document requirements, etc.)
3. REMS Communication Documents
a. Contribute to REMS communication initiatives such as publication plans, external presentations, and problem statement documents
4. External Risk Management/REMS Pharmaceutical and Regulatory Environment Monitoring
a. Create and maintain REMS strategy informational tools and database
b. Demonstrate expertise in the understanding of the complexity of international RMP-related regulatory guidances/legal requirements and contextual agility to accommodate customizations where country-specific requirements apply.
5. Management Reporting
a. Provide monthly reports on Risk Management reporting activities
a. Support the development, implementation, and optimization of GSRM RMP tracking including Additional activity tools, e.g., RMP Tracker/Verity, Local Market Implementation tracker (LMIT), PRISM, eSub, Veeva Vault (PromoMats) as an Subject Matter Expert
b. Serve as Risk Management internal database administrator
c. Key Subject Matter Expert for additional risk minimization measures for products
a. Contributor and represent Publishing and Support on cross functional projects within U.S. REMS in support of other U.S. REMS departments (Customer Care, Quality Operations, REMS Technology, and REMS Advisor/Training) as it may impact REMS submissions
b. Contribute to and or support procedure document updates (e.g. Best Practices, GRM job aids, International PV Manual updates, REMS Standard Operation Procedures, Work Practices) as required
c. Actively participate in meetings relating to Risk Management (e.g. various forums), as required
d. Propose creative solutions for continuous improvements to LM processes and or core activities and RM systems
e. Back-up or delegate for Manager, Documentation role as required.
f. Support internal audit and regulatory inspection activity as needed
g. Monitor GRM mailbox
h. 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
• Risk Evaluation Mitigation Strategies (REMS) and EU-Risk Management Plan knowledge and experience, highly desired
• Experienced in project 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.