Genmab
Sr Manager/Associate Director, Labeling, Policy, and Intelligence
This job is now closed
Job Description
- Req#: R12252
Employer Industry: Biotechnology
Why consider this job opportunity:
- Salary up to $248,400.00
- Opportunity for career advancement and growth within the organization
- Flexible work environment with the option for remote work
- Comprehensive benefits package supporting physical, financial, social, and emotional well-being
- Engage in impactful work that contributes to innovative cancer treatment solutions
- Collaborative and supportive workplace culture that values unique contributions
What to Expect (Job Responsibilities):
- Lead the development and maintenance of global labeling documents, including Company Core Data Sheets and United States Package Inserts
- Serve as the subject matter expert on global labeling strategies for the employer's product portfolio
- Manage complex projects, including collaborations with third-party partners
- Maintain up-to-date knowledge of global labeling guidelines and advise teams accordingly
- Prepare submission-ready labeling documents and ensure compliance with internal SOPs and external regulations
What is Required (Qualifications):
- Bachelor’s degree in a scientific discipline; PharmD/PhD preferred
- 3-5 years of pharmaceutical industry experience, with 2-3 years in labeling or a related field
- In-depth knowledge of US and global regulations related to labeling
- Experience developing and managing labeling content for major submissions, such as NDA/BLA
- Strong attention to detail and effective communication skills
How to Stand Out (Preferred Qualifications):
- Familiarity with end-to-end labeling processes
- Ability to evaluate the impact of regulatory intelligence on project strategy
- Experience working in a fast-growing, dynamic company
- Strong sensitivity for multicultural/multinational environments
- Proficiency with MS-Office Suite and Adobe Acrobat
#Biotechnology #RegulatoryAffairs #CareerOpportunity #CompetitivePay #InnovativeCulture
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We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.About the company
Genmab A/S is a Danish biotechnology company, founded in February 1999 by Florian Schönharting, at the time managing director of BankInvest Biomedical venture fund.
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