Sr. Scientist, Regulatory Affairs Full-time NEW

Senior Scientist, Global Labeling Lead

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:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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.

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 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.

The salary range for this role is $106,200.00 – $167,200.00. 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.