Position Overview - Basic Functions & Responsibility
Provides oversight of processes and projects related to risk management and additional risk minimization (ARMM)/risk communication. Leads preparation of regulatory documents and responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for assigned Oncology products. Highly advanced understanding of safety/risk management to allow for primary responsible for assigned departmental processes under the direction of the AVP/Executive Director. Empowered representative of CSRM department on cross functional process teams.
Primary Activities, Primary activities include, but are not limited to:
Independently work to expand and apply clinical, pharmacological, and epidemiologic knowledge and information technology skills to safety surveillance and risk management for assigned Oncology products in consultation with CSRM physician.
Support risk management and safety surveillance activities for assigned Oncology products.
Develop the overall strategy and lead the preparation of regulatory documents (e.g. aggregate reports, RMPs) and responses to safety inquiries from regulatory agencies, subsidiary staff and other internal customers in conjunction with the CSRM physician/management.
Displays advanced skill in developing and evaluating Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS) for assigned products in collaboration with the CSRM physician and Risk Management Safety Teams.
Accountable for the development and maintenance of assigned Risk Management processes (e.g. Additional Risk Minimization, REMS, risk communication) including primary responsibility in continuous process evaluation related to emerging regulations and engaging appropriate cross functional stakeholder engagement in these process activities on behalf of CSRM.
Accountable to CSRM leadership and Business Process Owner for assigned processes and IT and cross-functional projects related to Risk Management (e.g. ARMM, risk communication).
Display advanced knowledge of Pharmacovigilance and Risk Management Plans and strong mentoring skills to educate stakeholders outside of CSRM and less experienced CSRM staff.
Lead communication and educational efforts to product teams regarding risk management throughout clinical, submission and post-marketing phases.
Clinically relevant medical experience in the undergraduate or graduate program is essential (e.g. nursing, pharm D, PA, or other relevant clinical health-related field). Master’s degree in nursing, PharmD, PA or other relevant clinical health related field preferred.
8 – 10 years of professional experience with both clinical and pharmaceutical industry experience required, of which a minimum of 5 years MUST include safety experience (e.g. PV or clinical) involving analysis of aggregate safety data and authoring of safety documents. Direct experience with the planning, development and implementation additional risk minimization measures (ARMM), REMS, and risk communication essential.
Leadership experience/experience leading large cross functional projects highly preferred. Excellent writing and communication skills a must. Demonstrated leadership skills in overseeing large cross functional projects (IT projects a plus) and managing programs, processes, and facilitating meetings. Problem solving, compliance mindset and critical thinking skills.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
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