CR
credsystemIT Governance Specialist
Governance Specialist leading IT budget management and optimization projects at Credsystem. Overseeing compliance, risk management, and strategic decision - making with advanced dashboards.
About the role
- Support Head of SBRA, in defining and executing the strategic vision for the benefit-risk assessment function, aligning with organizational goals and regulatory requirements.
- Lead the benefit-risk assessment process across therapeutic areas from early clinical development through late-stage and post-marketing.
- Guide, steer and mentor the cross-functional Benefit-Risk Project Team (BRPT) in structured benefit-risk assessment of products.
- Lead development of Core SBRA document and facilitate effective communication and collaboration among internal stakeholders to achieve consensus on benefit risk profile of BMS medicines.
- Lead strategic discussions on the use of qualitative and/or quantitative methods for benefit risk assessment.
- Lead the BRPT in applying structured benefit-risk assessment.
- Provide guidance on the incorporation of the patient voice and patient preference studies for products in development as appropriate.
- Serve as a subject matter expert for questions from the BRPT and other functions, regarding content, methodology, tools and processes of SBRA.
- Support the development of decision context and identification of key benefits and key risks for BMS products and documentation of the rationale.
- Keep up to date with guidance and policy produced by regulatory agencies and other critical organizations regarding methodologies for benefit-risk assessment, patient preference studies, patient-focused drug development and other relevant guidance.
- Utilize and improve standard tools that support B-R Assessment: Benefit-risk assessment frameworks, Value tree, Effects table, Others as applicable to the submission strategy.
- Monitor and evaluate the evolving regulatory landscape to ensure compliance and best practices in benefit-risk assessment.
Requirements
- BS/BA required, advanced scientific degree preferred (Masters, PhD, PharmD etc.).
- Minimum of 10 years of relevant pharmaceutical industry, clinical, academic or relevant healthcare industry experience, with significant experience in global pharmaceutical safety risk management and benefit-risk management.
- Strong knowledge of processes and global regulations for pharmacovigilance and benefit-risk management.
- Demonstrated success in navigating a highly matrix-based organization to deliver against complex program plan.
- Exemplary leadership skills with proven ability to foster partnerships within a functional area and across organizational boundaries.
- Demonstrated problem-solving skills, including in challenging and ambiguous situations.
- Creative thinker with exceptional listening and analytical skills.
- Skilled at being adaptable/flexible and managing multiple demands and shifting priorities.
- Effective time management and comfortable handling risk and uncertainty.
- Ability to work effectively independently and manage multiple priorities.
- Ability to handle conflict, read situations quickly, and find common ground for achieving cooperation and resolution.
Benefits
- Medical, pharmacy, dental and vision care.
- Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
- Financial well-being resources and a 401(K).
- Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
- Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
- Parental, caregiver, bereavement, and military leave.
- Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
- Other perks like tuition reimbursement and a recognition program.
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