Job Description
The role will join a new hub in Czechia, GRACS (Global Regulatory Affairs and Clinical Safety), with a global scope of responsibilities across regulatory and clinical safety functions.
Essential functions include but are not limited to working independently, with guidance as needed, to plan and execute operational activities. Contributes to complex projects within GRACS and across areas in our Research & Development, our Manufacturing Division and GHH as needed to achieve overall quality goals. Assignments are of moderate complexity and require specific knowledge unique to the functional area as well as a broad understanding of GRACS and specific functional area processes and SOPs.
Primary activities include but are not limited to:
1. Independently supports departmental operational activities utilizing advanced competencies, knowledge and judgment; proactively identifies and resolves complex issues using experience with guidance and support from the GRACS leadership team and colleagues within and external to GRACS, as needed.
2. Serves as a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge. Applies capabilities to enhance quality and builds capabilities of less experienced staff, as appropriate.
3. May assist with planning functional group activities to achieve functional area and/or departmental objectives.
4. Conducts appropriate work in accordance with applicable and established Standard Operating Procedures (SOPs), applicable regulations (e.g., Good Regulatory Practice, Good Pharmacovigilance Practice, and Good Clinical Practice), safety guidelines and company policies and procedures. May assist with the preparation or review of relevant SOPs or policies relevant to GRACS or partnering our Research & Development/our Manufacturing Division/HH organizations.
5. Collaborates effectively across areas within GRACS and partnering organizations to achieve quality goals and understanding of and application of appropriate regulations in partnering our Research & Development areas.
6. May develop, contribute to, or lead educational and training materials and sessions to further develop competencies or process understanding across GRACS and partnering our Research & Development/our Manufacturing Division/HH areas, where applicable.
7. May provide direct support to system users globally for Systems and tools used by GRACS in support of the QMS execution and/or explore automation-based solutions for further digital enhancement of the QMS processes.
Primary skills include but are not limited to:
1. Collaboration and Partnering: Effectively partners with others (within GRACS and external to GRACS) to accomplish quality goals; possesses group leadership skills.
2. Communication Skills: Demonstrates advanced communications skills to convey and receive information. Demonstrates advanced oral and written communications skills.
3. Problem Solving: Demonstrates advanced level skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction.
4. Strategic Thinking: Effectively applies skills to drive or participate in change efforts to enhance processes within GRACS or across areas within our Research & Development that improve quality and /or add value to the business.
5. Project Management: Demonstrates advanced ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.
6. Decision Making: Effectively applies skills to utilize knowledge, networks and data to support rapid decision making with support of GRACS Quality and Compliance management.
7. Business Operations/Knowledge of Field: Effectively applies knowledge of regulations and business trends and applies this knowledge to optimize daily activities and collaborates with GRACS Quality and Compliance management to make appropriate decisions that improves the quality of business and functional area outputs.
8. Regulatory and Compliance Management: Demonstrates advanced knowledge of regulations and regulatory trends to ensure appropriate functional areas within GRACS are compliant with regulations and appropriate procedures and policies and proactively manages and mitigates risks to achieve quality outcomes.
Required education, skills & competencies:
Educations/Experience: BS/BA degree in relevant area with extensive experience in field.
Demonstrated experience in Regulatory Affairs and Pharmacovigilance (PV), including regulatory submissions, labeling, and safety reporting.
Proven experience managing inspections (regulatory and/or quality) and investigating, documenting, and resolving deviations and CAPAs.
Flexible and collaborative approach to quality-related responsibilities; able to prioritize and adapt in a fast-paced environment.
Required Skills:
Adaptability, Adaptability, Anti-Bribery and Corruption (ABC), Audits Compliance, Business Operations, Collaborative Problem Solving (CPS), Compliance Analytics, Compliance Program Development, Compliance Reporting, Data Analysis, Decision Making, Ethical Compliance, Financial Compliance, General Safety, Good Clinical Practice (GCP), Human Resource Information Systems (HRIS), IT Demand Management, Leadership, Marketing Compliance, Operational Decisions, Pharmacovigilance, Planning Operations, Prioritization, Quality Objectives, Regulatory Communications {+ 2 more}Preferred Skills:
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Employee Status:
RegularRelocation:
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Job Posting End Date:
11/14/2025*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.