The Manager, Risk Evaluation and Mitigation Strategy (REMS) is responsible for directing and managing the REMS Department including developing product safety activities as well as any additional Risk Management activities conducted by Mallinckrodt. The Manager will collaborate in the planning, implementation and execution of activities related to the REMS Programs for product specific and/or class-wide REMS requirements. Once a REMS Program is operational, this individual will oversee the operations, acting as Mallinckrodt’s liaison with outsourced vendors handling REMS activities. This individual provides internal direction, leadership and accountability for the company’s REMS programs and day-to-day management of the key risk management vendors as applicable.
The Manager will play a pivotal role in managing timelines and deliverables for key risk management milestones for the company. This individual can effectively apply project management related support to meet overall corporate objectives in building a compliant REMS program.
Serve as Mallinckrodt representative who collaborates with colleagues towards a shared, single system REMS Program.
Provide vendor management – including managing of requests for proposals from initial request through coordinating and clarifying responses, develop and manage contracts, invoice reviews and approvals, evaluation and selection and deliverable reviews.
Responsible for the development of REMS strategy for new products (i.e., drugs in development).
Oversee and execute operational aspects of REMS activities as well as assigned special projects.
Prepare budgets/forecasts and track financials. Responsible for setting and managing overall project timelines and budgets for assigned projects.
Develop and implement key metrics to measure and report on progress of all initiatives.
Collaborate with Regulatory Affairs to compile REMS submissions and reports to the Food and Drug Administration (FDA).
Evaluate learning opportunities to create a training platform for Mallinckrodt employees.
Create training for Mallinckrodt personnel on patient safety, product risk minimization and other risk management issues; could facilitate as expert, use existing training content, work with a third party, etc.
Serve as a consultant to business development & licensing, marketing, and research & development to conduct product risk assessment.
Prepare risk assessment profiles for Product Development Team (PDT) and Safety review.
Monitor external environment for regulatory changes impacting risk management.
Chair Risk Management Core Team; facilitates topics and meetings for business review, approvals, discussion, etc.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Other duties as assigned with or without accommodation.
Interact internally with medical professionals and business leaders to assist in product benefit/risk assessment.
Externally, interfaces regularly with healthcare professionals, non-profit organizational leaders and staff, and governmental agencies to advance department initiatives.
Master’s degree in a healthcare or related discipline with a business/financial background required.
A minimum of 8 years of directly related work experience required with at least 3 years of risk management and/or project management experience preferred.
Experience with and working knowledge of the risk management, REMS and the regulatory process are strongly preferred.
Experience managing and leading the successful implementation of complex projects with multiple internal and external stakeholders.
Experience leading cross-functional project teams is required.
Financial planning & budget management skills are required.
Excellent verbal and written communication skills with the ability to interface with senior management, interdisciplinary project teams, subordinates and external vendors.
Strong leadership skills a must
Superior computer skills required in order to utilize software programs such as Excel, Word, and PowerPoint as well as MS Project
Formal training in Epidemiology a plus
Sound organizational skills with the ability to prioritize tasks
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Mallinckrodt is a global specialty biopharmaceutical and medical imaging business that develops, manufactures, markets and distributes specialty pharmaceutical products and medical imaging agents. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory cr...itical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Global Medical Imaging segment includes contrast media and nuclear imaging agents.