Associate Director Global Risk Management GRM Strategy

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.

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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