Company name
Bristol-Myers Squibb Company
Location
Summit, NJ, United States
Employment Type
Full-Time
Industry
Manager, Healthcare, Pharmaceutical
Posted on
Apr 18, 2020
Profile
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Summary:
The Associate Director, Global Risk Management Strategy reports to the Executive Director, Global Risk Management Strategy and will be responsible for development and submission activities (to Health Authorities) in support of, and the assessment of Risk Management Plans and/or REMS programs. This Associate Director will work with Celgene teams (Safety, Submission, etc.) and the overarching Global Risk Management department to develop and produce Risk Management/REMS program content and be responsible for the delivery of Risk Management Plan documents as well as direct external vendors to support the overall RMP/REMS Submission process. They will also work within GRM and other departments to help ensure the successful implementation and operations of RM programs. The Associate Director will also be responsible for and support assigned GRM Strategy Department projects such as internal and external Risk Management communications and education, execution of publication plans, and strategic involvement of process improvement and department metrics as well as data analysis as required.
Responsibilities will include, but are not limited to the following:
Risk Management Plan/REMS program development and regulatory submissions
Primarily partake in and manage the development of RMP and/or REMS content and program components (including REMS modifications, MAA/NDA/BLA/sNDA risk management submissions, communications, etc.) for MAA/NDA/BLA submission to the appropriate health authorities
Manage and responsible for the REMS/RMP submission documents through the review and approval phases by health authorities
Aid in the organization and appropriate documentation of the (within internal databases) the formal internal review process for Risk Management Plan regulatory submissions to ensure the integrity and compliance of RMP/REMS regulatory submissions are maintained
Liaise with internal Celgene multidisciplinary RMP/REMS stakeholders (Submission teams, Lead Safety Physicians, Regulatory Affairs, Biostats, Regulatory Operations, Global Risk Management Technology, Global Risk Management Operations, and Legal) to keep track of and ensure capture of updates within Risk Management submissions
Support and collaborate members of Global Risk Management Team and vendors as necessary to create supplementary materials to support Risk Management regulatory submissions
Serve as Risk Management Material project champion to foster the review and approval of additional Risk Minimization Measures or REMS materials in need of multidisciplinary review and approval
Direct internal and external stakeholders and vendors to create and supply the necessary components to complete the Risk Management Plan submission at hand
Ensure the utmost quality of RMP/REMS submission content through in-depth review of submitted documents, attention to detail, and verification of facts/changes to materials
Utilize project management skills to ensure high quality deliverables are provided in a timely manner
Risk management assessment requirements
Drives the narrative development process and data analysis of high-quality health authority deliverables such as REMS Assessment Reports, FDA response inquiries, RMP documents, ad hoc survey results, etc.
Ensure the coordination and execution of timely and efficient internal review and approvals of deliverables
Collaborate with other internal departments to obtain information and data as needed to support the creation and development of RM assessment deliverables, support responses to Regulatory Agencies from assessment reports of RMPs and PSURs
Ensures the quality of output documents and ensures content meets appropriate editorial standards (style, formatting, document requirements, etc.)
Support Aggregate Safety Report (ASR) production activities across GDSRM and entire Global Safety Network (GSN) including PSURs, US PSRs, DSURs as required
Manage GRM Strategy’s role in execution of REMS and RMP program development, liaising with other GRM colleagues to ensure successful RM implementation and operations of new and existing RM programs and pipeline products
Responsible for the execution of assigned RM projects, which include:
Manage relationships with internal and external stakeholders
Produce project plans and monitor progress to ensure project goals are achieved
Negotiate timeline and resource requirements
Define and monitor budgets
Manage scope change process
Create project status reports for different audiences
Lead status meetings to ensure transparency and engagement
Establish and cultivate the optimal environment to enable high-performing teams
Risk management communication documents as needed
Develop and deliver Risk Management communication initiatives (e.g. publication plans, external presentations, and problem statement documents) as required
Support other Risk Management departments
Data analysis and management with reporting
Obtain, analyze, and summarize REMS data to provide data-driven conclusions and make appropriate recommendations/solutions
Provide monthly reports on GRM Strategy and Policy activities as required
Other
Represent Global Risk Management Strategy on cross functional projects
Support internal audit and regulatory inspection activity as needed
Assist with ad hoc projects and additional tasks as assigned
Management of strategic departmental initiatives, process improvements, and people management as appropriate
Minimum Qualifications:
BS/BA required, advanced degree in healthcare science, public health, or applicable fields, preferred
7 years previous experience in Pharmaceutical Industry (Risk Management Program Operations, Medical Communications, Regulatory, or Safety/Pharmacovigilance or relevant disciplines)
Have advanced skills in MS Word, Excel, and PowerPoint.
Possess knowledge of clinical trials & drug development, commercial drug development, and understanding of safety data capture in CT & PM settingsMedical/RMP/REMS document preparation experience, a highly desired
Appreciation and knowledge of the global safety environment, international regulations, compliance regulations, and guidance documents applicable to risk management (US, EMA, ICH)
RMP and REMS program development knowledge and experience, highly desired
Desired Competencies:
Ability to independently manage multiple projects with accountability and excellent work ethic
Proven skills in respectful collaboration with cross-functional teams and in a team environment
Excellent and effective verbal and written communication skills with the ability to interface with GRM Leadership team, interdisciplinary submission teams, and external vendors
Acute attention to detail
Adaptive, resilient, and nimble character, yet firm and sturdy in conviction and ethics
Highly strategic, proactively recognizes problems and foresees opportunities with a tendency to act with a solutions-driven attitude
Demonstrated high degree of independence with effective presentation and interpersonal skills to ensure a team-oriented approach
Ability to analyze risk management program operational data and in turn recommend strategies, and prepare written reports and presentations
Team Building and People Management
Positive attitude of collaboration and continuous learning and improvement, a must.
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 the resources to pursue their goals, both at work and in their personal lives.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Company info
Bristol-Myers Squibb Company
Website : http://www.bms.com