Manager, Regulatory Affairs

San José
Permanente
Tiempo completo

Hace 9 días

Job DescriptionWe invite you to join our Team!Global Submissions Publishing, comprised of Regulatory Content Management and Submission Publishing, works closely with various stakeholders to ensure the timely completion of submission components and assemblies that adhere to global regulatory health authority policies and technical requirements as well as internal guidelines for electronic/hardcopy submissions.This position is responsible for supporting the technical integrity of submission components, ensuring that all elements comply with essential standards necessary for submission readiness.Key Responsibilities:Document Management: Set up document templates, format and publish documents, conduct quality control, and manage submission references to ensure accuracy and adherence to standards; distribute final documents as required.Submission-Ready Components: Deliver submission-ready components that facilitate an efficient submission publishing assembly process.Collaboration: Collaborate with authors, contributors and stakeholders to ensure high-quality outputs, enhance project outcomes and drive collective success.Testing and Implementation of New Tools and Processes: Engage in the testing and evaluation of new publishing tools and processes. Provide feedback and suggestions for improvements to enhance efficiency and effectiveness.Development of Administrative Documentation: Assist in the creation and maintenance of administrative documentation, including standard operating procedures, execution resources, guidelines and training materials to support publishing processes.Continuous Learning and Development: Stay informed about industry trends, best practices, and regulatory changes related to publishing sciences.Lead Publisher for Complex Submissions: Assume the role of lead publisher for larger, complex documents and submissions. Coordinate all publishing-related activities and delegate tasks to other publishers as needed to ensure efficient workflow.Subject Matter Expertise: Serve as a subject matter expert for specific functions or processes. Evaluate activities and business processes, identifying areas in need of improvement and leading investigations into potential solutions or new ways of working.Risk Management and Issue Resolution: Identify, assess, and actively resolve or escalate any risks or issues that could impact the successful completion of submissions. Collaborate with cross-functional teams to ensure timely identification and mitigation of potential challenges.Management, Mentoring and Collaboration: Provide mentoring to inter-departmental and external stakeholders to enhance understanding and compliance with regulatory requirements. Manage projects and drive process improvement initiatives. Manage and develop a team of direct reports with a keen commitment to providing value. Coach staff in the concepts, methods, and nuances of regulatory project management, drug development, and regulatory operations.Education & Experience Minimum Requirement:

Bachelor’s degree
Five (5) or more years of regulatory affairs experience
English proficiency, in oral and written

Required Experience:· Interpersonal Skills: Ability to work collaboratively with others and communicate effectively, both verbally and in writing.· Technical Proficiency: Expert knowledge of computer programs such as MS Word and Adobe Acrobat Professional as well as industry standard publishing systems, with a demonstrated ability to learn new systems and technologies quickly.· Time Management: Strong organizational skills to manage multiple time-sensitive assignments efficiently.· Adaptability: Flexibility to adapt to a changing environment, staying current with new and updated processes and procedures.· Cultural Sensitivity: Strong interpersonal skills and experience in handling diverse cultures, with effective communication skills in English and regional languages.· Quality and Compliance Awareness: Demonstrates a deep understanding and executes the business value of quality and compliance, recognizing the implications and risks of non-compliance. Adjusts behaviors to drive high-quality deliverables.· Problem Solving and Critical Thinking: Ability to independently identify and resolve problems that arise within job responsibilities, ensuring a proactive approach to challenges.· Team Management and Development: Demonstrated experience in leading, managing, coaching, and developing teams.Current Employees applyCurrent Contingent Workers applySearch 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: No Travel RequiredFlexible Work Arrangements: HybridShift: 1st - DayValid Driving License: YesHazardous Material(s): n.aRequired Skills: Adverse Event Report, Audits Compliance, Business Processes, Communication, Compliance Assessments, Critical Thinking, Cross-Functional Teamwork, Detail-Oriented, Process Improvement Projects, Regulatory Affairs Compliance, Regulatory Project Management, Team Management, Technical Documentation ManagementPreferred Skills:Job Posting End Date: 09/10/2025*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.

MSD

Postularse