Sr. Scientist-Global Labeling Lead
Merck · Rahway, NJ · 1 mo ago
$106k–$167k/yrFull-time
We need to output HTML fragment with sections for headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title. Must not include Job ID etc. Must preserve all substantive info. Remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. Also remove lines like "Current Employees apply HERE", "Current Contingent Workers apply HERE", "US And Puerto Rico Residents Only", "Our company is committed to inclusion..." etc. Also remove EEO statements, accommodation, etc. Also remove "Search Firm Representatives Please Read Carefully..." etc. Also remove "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 09/26/2026 ..." etc. Also remove "Requisition ID:R416023". Also remove "#EligibleforERP". Also remove "Required Skills Action-Oriented, Adaptability, ..."? Actually those are skills list; we need to keep skills. The "Required Skills" list is part of skills. The "Preferred Skills" also part of skills. We'll combine.
We need sections:
- About the role: likely the introductory paragraph(s) describing mission and purpose. The text: "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." That's about role.
- Responsibilities: bullet list of duties: developing labeling content, maintaining target product labeling, Core Labeling documents, US Labeling, EU Labeling, supporting country Regulatory Affairs, etc. Also the list under "The Senior Scientist, Global Labeling Lead Is Responsible For" includes many items. We'll extract each as bullet.
- Requirements: maybe education? Actually "Education Bachelor's degree in a scientific or medically related discipline required; advanced degree (M.S., Pharm.D., or Ph.D.) preferred." That's qualifications. Also "Required Experience & Skills Minimum of 3 years of labeling experience or other relevant pharmaceutical industry experience..." That's requirements/experience. We'll separate Qualifications (education) and Requirements (experience). But guidelines: we have headings Qualifications, Requirements, Skills. We'll put education under Qualifications. Experience under Requirements. Skills under Skills.
- Benefits: we have "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." Also mention annual bonus and long-term incentive. Also maybe "The successful candidate will be eligible for annual bonus and long-term incentive, if applicable." That's benefits.
- Pay: salary range "$106,200.00 - $167,200.00". Also mention that salary based on factors. We'll include Pay section with that range.
- Schedule: maybe "Travel Requirements 10% Flexible Work Arrangements Hybrid Shift Not Indicated". That's schedule info: travel 10%, flexible work arrangements hybrid. We'll include Schedule section with that.
We must not include sections with placeholder or vague like "commensurate with experience". Not present.
We must not repeat job title. Not include Job ID etc.
We must output only HTML fragment, no /, no markdown fences.
Let's craft.
Structure:
About the role
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.
Responsibilities
- 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
Qualifications
Bachelor's degree in a scientific or medically related discipline required; advanced degree (M.S., Pharm.D., or Ph.D.) preferred.
Requirements
- Minimum of 3 years of labeling experience or other relevant pharmaceutical industry experience (e.g., Medical Affairs, Regulatory Affairs, Clinical, or Pharmacovigilance)
- An advanced degree with relevant labeling or pharmaceutical industry experience gained during graduate studies may be considered equivalent to the experience requirement
- Experience leading cross-functional labeling teams, including interactions with senior management, strongly preferred
- Demonstrated ability to actively listen, address labeling issues, develop action plans, build consensus, and drive projects to completion
- Ability to assimilate complex clinical and scientific information, labeling precedents, and competitor labeling, and communicate findings clearly and concisely
- Understanding of medical concepts and terminology
- Project management skills with the ability to manage multiple priorities and meet deadlines
- Proactive problem-solving skills with the ability to make sound recommendations and decisions
- Ability to work effectively in ambiguous environments and maintain an action-oriented approach
- Strong written and verbal communication skills
- High attention to detail and commitment to accuracy
- Demonstrated ability to influence, negotiate, and collaborate across functions
Skills
- Action-Oriented
- Adaptability
- Adverse Event Report
- Communication
- Detail-Oriented
- Labeling Compliance
- Negotiation
- Pharmaceutical Product Development
- Policy Implementation
- Problem Solving
- Regulatory Strategy Development
- Regulatory Submissions
- Scientific Knowledge
- Technical Writing
- Time Prioritization
Benefits
- Comprehensive benefits package including medical, dental, vision healthcare and other insurance benefits (employee and family)
- Retirement benefits, including 401(k)
- Paid holidays, vacation, and compassionate and sick days
- Eligibility for annual bonus and long-term incentive (if applicable)
Pay
Salary range: $106,200.00 - $167,200.00 (based on education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs)
Schedule
- Travel requirement: approximately 10%
- Flexible work arrangements: hybrid