Sr. Scientist-Global Labeling Lead

** 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*
* + Bachelor's degree in a scientific or medically related discipline required; advanced degree (M.S., Pharm.D., or Ph.D.) preferred.

** Required Experience & Skills*
* + 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.

EligibleforERP

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* Required Skills:

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* 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

** Preferred

Skills:

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* Current Employees apply HERE ($6687.htmld)

Current Contingent Workers apply HERE ($4020.htmld)

** 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  ()  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.  

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