- Project Management
- Oversees all projects' progress, identifies risks, and provides expertise to resolve project difficulties to meet project deadlines required to deliver products to market effectively.
- Projects include but are not limited to R&D/formulation projects, new product launches, scale-ups, alternate API sources, site changes, external product integration, and business development opportunities.
- Conducts team meetings/teleconferences and provides concise executive updates to senior leadership.
- Responsible for planning and executing assigned projects, managing associated budgets, timelines, and other project-specific deliverables within the scope of the initiative/project.
- Assess risks, develop mitigation plans, and lead regular team meetings working across functionally.
- Track projects and provide timely/relevant project status updates to the management team.
- Communication & Collaboration
- Engage & leverage senior leadership frequently, direct or support members of internal cross-functional teams, and interface with external counterparts to ensure corporate goals are achieved via a productive working relationship.
- Communicate with R&D, Regulatory, Analytical R&D, Manufacturing, Quality Control, and Quality Assurance throughout the development and submission process to ensure all submission related documents are assembled and reviewed on an ongoing basis, with problems identified and addressed concurrently.
- Risk Analysis
- Evaluate the probability and impact of risks and develop plans for minimizing their impact on the project.
- Due Diligence and Integration Support
- Interface with Business Development for a streamlined handoff from deal execution to integration on mergers, acquisitions, and product collaborations.
- Provide support for due diligence and integration meetings acquisitions.
- Demonstrated ability to work independently, proactively, and with agility in a complex, matrixed environment, building internal alignment, influencing others, and managing differences effectively.
- Proven ability to identify, prioritize & resolve critical project and partner issues, and work with and harmonize demands from multiple "customers" internally and with partners.
- Demonstrated ability to combine attention to detail with big picture perspective, operationalizing via excellence in project management and effectively managing multiple projects/priorities.
- Excellent oral and written communication skills.
- Polished people skills, people-centered and team-based in thinking.
- Bachelor's degree in a scientific or other related discipline.
- 5+ years' experience in the pharmaceutical industry.
- 2+ years of experience in project management or alliance management.
- Experience working with 3rd parties, CMO and CDMOs.
- Proven experience filing and launching ANDAs.
- Drug development knowledge with good understanding of other functions relevant to the position, including R&D, Technical Operations/CMC, Regulatory, and Commercial.
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R&D Project Manager - Hightstown, United States - ANI Pharmaceuticals, Inc.
Description
Job Description
Job DescriptionAbout UsWelcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products.
With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally.
About the Role
The R&D Project Manager leads ANI's Project Management function and oversees the cross-functional activities for the entire portfolio of R&D projects through the drug development process. In this capacity, the Project Manager works closely with R&D, Regulatory, Operations, and QA/QC to track and manage the products from development through approval and launch. The Project Manager is expected to foster trust and collaboration amongst departments and be skilled in managing 3rd party relationships, reviewing quotations, and assisting in contract negotiations, including licensing, development, or supply agreements and terminations.
The R&D Project Manager will be based primarily at our East Windsor, NJ facility, with an occasional presence at ANI's Princeton, NJ site.
Position Responsibilities:
Please note that ANI does not accept search agency or third-party emails, calls, or solicitations.
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