- Bristol Myers Squibb (Princeton, NJ)
- …mechanisms with focus on Omnichannel & AI team outcomes. + Ensure US and global regulatory , privacy, and data governance standards are harmonized and embedded, ... effective communication, and facilitates the execution of strategic priorities across the global Omnichannel & AI organization. As a dynamic leader, the Director… more
- Ascendis Pharma (Princeton, NJ)
- …validated Drug Safety Databases (Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Expert knowledge of FDA ... safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global ...applicable regulatory guidance documents; working knowledge of global safety regulations. + Ability to travel up to… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …and congress activities + Collaborate with Medical Affairs, Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Regulatory , and Commercial ... meetings + Ensure all congress and medical education activities comply with global and local regulatory requirements, Otsuka policies, data publication embargos… more
- J&J Family of Companies (Titusville, NJ)
- …within area of responsibility. + Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and ... to the end user. Support tech transfer activities through process validation and regulatory approval. + Author, approve or support the writing of URSs (User… more
- J&J Family of Companies (Titusville, NJ)
- …within area of responsibility * Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and ... to the end user. Support tech transfer activities through process validation and regulatory approval. * Create or support the writing of URSs (User Requirement… more
- Honeywell (Hamilton, NJ)
- …Experience with digital transformation initiatives in pharma or biotech. + Familiarity with global regulatory frameworks (eg, FDA, EMA, ISO). + Exposure to ... value propositions tailored to life sciences personas. + Align messaging with regulatory , operational, and innovation drivers in manufacturing and quality. + Partner… more
- J&J Family of Companies (Titusville, NJ)
- …responsibility * Ensure compliance with all applicable cGMPs, EU Annex 1, global regulatory requirements, safety, environmental regulations, SOPs, WI's and ... to the end user. Support tech transfer activities through process validation and regulatory approval. * Create or support the writing of URSs (User Requirement… more
- J&J Family of Companies (Titusville, NJ)
- …within area of responsibility. + Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI's and ... end user. Support tech transfer activities through process validation and regulatory approval. + Ownership for clean utility systems throughout project execution,… more
- J&J Family of Companies (Titusville, NJ)
- …responsibility. * Ensure compliance with all applicable cGMPs, EU Annex 1, global regulatory requirements, safety, environmental regulations, SOPs, WI's and ... to the end user. Support tech transfer activities through process validation and regulatory approval. * Create or support the writing of URSs (User Requirement… more
- Oracle (Trenton, NJ)
- …and stakeholder communication for smooth and timely rollouts. + **Support Global Compliance & Certification:** Collaborate with legal, regulatory , and ... **operational alignment with international compliance frameworks and medical device regulatory requirements** as HDI scales its solutions globally. **Responsibilities**… more