Sr. Director, Regulatory Affairs/Drug Safety

Job Description

Highly advanced understanding of safety and/or risk management to allow for overall accountability for the assigned cross-departmental process owned by CSRM. The incumbent will have end to end accountability for CSRM owned process including the related SOPs and Execution resources. The incumbent is accountable to Sr. Director of Business Process and Systems with input from VP, CSRM as needed, for process direction and oversight, including ensuring consistency of execution, development and monitoring of metrics and continuous oversight for success of process as applied to the relevant products. Empowered representative of CSRM department on cross functional and cross divisional process teams. The incumbent may have continued product accountabilities including the development and execution of pharmacovigilance and risk management plans under the overall direction of the CSRM physician/TA CSRM management.

• As the end-to-end process owner, oversee the development and maintenance of departmental SOPs that contribute to the assigned process including overall accountability for ensuring appropriate cross functional and cross divisional stakeholder engagement in these process activities on behalf of CRSM.

• Independently evaluate and assess emerging regulations to anticipate necessary changes to any aspect of assigned process and lead integration of SOP owner activities to ensure a compliant end-to-end process.

• Evaluate and lead continuous process evaluation/optimization, metric development, collection and monitoring compliance of assigned process with input from Subject Matter Experts, and CSRM leadership as appropriate.

• Serves as single point of contact for assigned process for all key internal and external stakeholders, contributing functional areas and process governance committees. Works with Sr. Director for Business Process and Systems,  CSRM to develop and implement mitigation plans for process risks, as necessary.

• Act as an expert in advanced pharmacovigilance and risk management, mentoring stakeholders outside CSRM on areas of responsibility within assigned cross functional process to optimize compliance.

• Oversees communication and informational efforts to cross divisional contributors regarding process changes, required training and emerging issues related to assigned processes.

• Serves as overall process expert and leads engagement as needed with auditors, inspectors and other regulators on behalf of the company.

• For assigned product related work, uses advanced skill in performing safety surveillance activities and developing and evaluating PV activities, Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS) for assigned products in collaboration with the CSRM physician.

• Manage and prepare strategies for regulatory documents and responses to safety inquiries from healthcare professionals, regulatory agencies, subsidiary staff and other internal customers in conjunction with the CSRM physician/management for assigned product(s) as needed.

Education Requirements:

• Clinically relevant medical experience in the undergraduate or graduate program (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.

• A professional background of approximately 10-12 years in both clinical and pharmaceutical industry is required, with at least 5 years specifically involving safety experience (such as Pharmacovigilance or clinical work)  involving direct participation in a variety of PV processes.

• Excellent writing and communication skills a must. Experience in data analysis or the interpretation of adverse experience information is a plus. Demonstrated leadership skills in managing programs, processes, and facilitating meetings. Problem solving, compliance mindset and critical thinking skills.

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.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan