Sr. Director, Regulatory Affairs/Drug Safety

Job title:

Sr. Director, Regulatory Affairs/Drug Safety

Company

MSD

Job description

Job DescriptionHighly 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 APPLICANTSIn accordance with 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 Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.#GRACS#EligibleForERPEmployees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees applyCurrent Contingent Workers applyUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: 10%Flexible Work Arrangements: HybridShift: Not IndicatedValid Driving License: NoHazardous Material(s): n/aJob Posting End Date: 10/2/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Expected salary

Location

Gwynedd, PA – Wales

Job date

Sun, 22 Sep 2024 02:39:16 GMT

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