We are looking for a Project Manager, Generics, for a Central NJ based fully integrate pharmaceutical company, with OTC, Generic, and Brand RX business.
The company and it’s generic pharmaceutical (Rx) division offers a number of high quality cost efficient products available for commercial distribution. They have an aggressive development pipeline in place to market highly sought after generic Rx products to the US market. This individual will possess Pharmaceutical Generic Drug Development Experience, experience working on programs focusing on the development of generic pharmaceutical products, technical transfer to manufacturing, coordinating clinical study with CRO. This drug development experience would include formulation, chemistry, regulator knowledge etc.
- Partner with local site heads and teams, R&D team, Regulatory team, Marketing, Supply Chain, Operations, key stakeholders to define project and program objectives, deliverables, and annual and long-range operating work plans; identify resources (e.g. FTEs, budget, etc.); and ensure execution and progress towards deliverables and milestones;
- Work proactively with respective local and global teams, management, and governance on risk assessments and management;
- Develop and maintain comprehensive periodic (e.g. weekly, biweekly, and monthly) updates to teams, management, and governance, using various project & program management tools.
MINIMUM/ PREFERRED REQUIREMENTS:
BA/BS Required; MBA Preferred; relevant certification and training (e.g. PMP, Operational Excellence Lean Six Sigma, Etc.) Preferred
5-7 years broad experience in pharmaceutical industry and a minimum of at least 3 years of experience within Generic Pharmaceutical market
- Experience in Operations, CMC and other related areas with emphasis on project management of commercial product portfolio assets in pharmaceuticals
- Strong understanding of FDA requirements related to Pharmaceuticals
- The ideal candidate will have experience working in a core team environment where you share the time of Subject Matter Experts with other project teams
- Driven self-starter
- Strong communication skills
- Well organized and attention to detail
- Comfortable working in teams, necessary to “follow-up/” “push” without alienating