A NJ based Pharmaceutical company is looking for an Senior Manager, Legal & Clinical Compliance to join their team in this hybrid position. You'll be onsite 2-3 days a week.
Responsibilities:
Contract Development & Negotiation:
- Responsible for overseeing contract development and negotiating with vendors.
- Develop, refine, and organize contract templates, standardized provisions, and guidance for all attorneys working on contract preparation to ensure all contracts comply with laws and regulations, and address potential risks and issues associated with contracts.
- Negotiate a broad range of critical contracts including Clinical, R&D, Managed Care rebate and patient support, and Marketing contracts.
Patent Due Diligence and Management:
- Lead and direct management and oversight of patents.
- This will include educating and influencing key stakeholders about initial considerations and the due diligence required specifically for Business Development and product life-cycle management decision making.
- Provide rational, strategic decision making not only on pursuing and maintaining patents, but on integrating knowledge about patents and exclusivity, into decisions about products and their commercialization.
- Lead change management practices to facilitate implementations and transitions related to patents.
- Routine maintenance of effective control documents and filings.
Legal Operations:
- Develop, refine, and drive efficiency and surety in Legal operations, particularly focusing on the contracting process, but also involving practices across all Legal functions including Authorizations to do Business, State Manufacturers Licenses, etc.
- Lead development of systems, including but not limited to software implementations, is increasingly an essential function of the company, and the Legal department needs to be an active participant. Meeting all the requirements while maintaining simplicity as much as possible involves knowledgeable and insightful development of work streams, filing systems.
- Well-versed in software and applications such as those for contract management, content and knowledge management, Intellectual Property management, business process enhancement, e-signature, board of directors management, eDiscovery, litigation hold, compliance management and subsidiary management.
- Lead change management practices to facilitate implementations and transitions related to technology, processes, and people.
- Routine maintenance of effective control documents and filings.
Litigation Operations:
- Develop and design standardized and documented best practices for litigation operations including but not limited to litigation holds, document holds, status memoranda, and other processes such as coordinating with Outside Counsel.
- Lead change management practices to facilitate implementations and transitions related to litigation operations.
- Routine maintenance of effective control documents and filings.
Required Qualifications:
- Juris Doctorate
- Licensed Attorney
- 4+ years working in a challenging corporate environment.
- Pharmaceutical or drug device company experience.
- Contract development and negotiation experience (clinical, R&D, Managed Care rebate and patient support)
- Expert in Microsoft Office, Adobe Professional, Veeva, OpenSource, and SharePoint.
- Experience identifying, creating, and implementing novel approaches to mitigate risk.
- Commitment to ethical conduct; manage confidential and proprietary information using excellent discretion and judgment.
- Strong interpersonal skills with ability to develop and maintain effective cross-functional relationships with stakeholders.
- Excellent communication skills, both written and verbal.
- Ability to work both independently and collaboratively.
- Excellent attention to detail. Excellent writing and editing skills.
- Organization and facilitating organization among working groups.
- Collaboration and project management capabilities, including effectiveness in driving tasks and process improvements and standards across departments.
- Presentation development and delivery skills.
- Maintaining knowledge on a wide range of legal requirements binding the company's operations.
If you meet the required qualifications and are interested in this role, please apply today.
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