Product Management Specialist at Honeywell, managing product lifecycles for safety technologies and delivering expert training programs.
About the role
- Associate Director leading global labeling strategy at Johnson & Johnson, fostering innovations in healthcare. Collaborating on regulatory processes to enhance drug labeling quality.
Responsibilities
- Drive the global labeling strategy
- Take a leadership role and partner with Global Regulatory Leads (GRLs) and other functional area partners
- Lead target labeling development
- Collaborate with functional areas to provide labeling input
- Provide strategic labeling advice for local labeling in major markets
- Analyze relevant competitor labeling
- Lead Health Authority (HA) labeling strategy discussions
- Lead the development, revision, review, agreement, and maintenance of target labeling
- Lead cross-functional Labeling Working Group (LWG) and strategic labeling discussions
- Represent global labeling in Global Regulatory teams and other cross-functional teams
- Present at governance meetings
- Ensure high quality and compliant labeling documents
Requirements
- Minimum of a Bachelor’s degree in a scientific discipline
- Minimum of 8 years of professional work experience
- Minimum of 6 years of direct regulatory labeling content experience
- Direct experience with target labeling development or New Molecular Entity (NME) submissions preferred
- Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) required
- An understanding of pharmaceutical drug development required
- Good understanding of worldwide regulatory guidelines and their application for guidance for labeling required
- Experience leading project teams in a matrix environment required
- Must have exceptional verbal and written communication skills
- Must have strong organizational, negotiation, and partnering skills
Benefits
- An inclusive work environment
- Health is everything
- Expertise in Innovative Medicine and MedTech
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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