Sr. Scientist, Regulatory Affairs at Merck Sharp & Dohme Corp. /Netherlands

North Wales, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Jul, 26

Salary

167200.0

Posted On

04 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Labeling Strategy, Core Labeling, Regulatory Compliance, Project Management, Clinical Information Analysis, Medical Terminology, Cross-functional Leadership, Technical Writing, Negotiation, Influence, Problem-solving, Regulatory Submissions, Pharmacovigilance, Medical Affairs, Regulatory Strategy Development

Industry

Pharmaceutical Manufacturing

Description

Job Description We invite you to join our mission of advancing the prevention and treatment of diseases. The purpose of Global Labeling is to drive labeling strategy and ensure high-quality and compliant labeling documents which, provide the safe and effective use of products for patients and healthcare providers globally. As part of Labeling Strategy function in Global Labeling, you will be accountable for developing labeling content and maintaining the target product labeling for developmental products, Core Labeling documents (e.g., CCDS, CCPPI, CCIFU) , US Labeling, and EU Labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of other country’s Local Labeling. The Senior Scientist, Global Labeling Lead is responsible for: developing, maintaining, and implementing Core Labeling for assigned products in line with internal standards and guidelines developing, maintaining, and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines assisting with developing and maintaining Local Labeling (EU and most of world) for assigned products providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions for assigned products leading cross-functional teams to develop, review and approve Core and Local Labeling documents recommending strategies and labeling language for inclusion in Core or Local Labeling during labeling development or responses to Health Authority Education Required: Bachelor’s degree in a scientific or medically related discipline. Preferred: Advanced degree (M.S., Pharm.D, Ph.D.). Required Experience & Skills Minimum of 3 years of labeling experience or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance). Experience in leading cross-functional labeling team (including senior management) exhibiting a combination of active listening skills and the confidence to address labeling issues, develop plans of action, drive consensus, and oversee completion of labeling project. Ability to assimilate clinical and scientific information, labeling precedent and competitor labeling, and present it concisely. Understanding of medical concepts and terminology. Project management skills with the ability to handle multiple projects and prioritize work accordingly. Proactive problem-solving ability with the ability to make appropriate recommendations/decisions. Tolerance for ambiguity and action-oriented. Strong written and oral communication skills. Attention to detail and accuracy. Ability to influence and negotiate. Required Skills: Adverse Event Report, Clinical Medicine, Compliance Investigations, Decision Making, Detail-Oriented, Disease Prevention, Documentations, Employee Training Programs, Labeling Compliance, Maintenance Processes, Manufacturing Compliance, Multi-Management, Negotiation, Oral Communications, Pharmaceutical Management, Policy Implementation, Proactive Thinking, Records Retention Management, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Strategy Development, Regulatory Submissions, Technical Writing Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US 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 click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective 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, Monday - 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”. The salary range for this role is $106,200.00 - $167,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance 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: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 04/11/2026 *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. Requisition ID:R391912

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

The Senior Scientist is responsible for developing and maintaining global labeling content, including Core, US, and EU labeling documents. They serve as the regulatory point of contact on global sub-teams to ensure compliance and timely delivery of labeling submissions.