Director

• Jan 2022 - Present

Associate Director Contract Management

• Jun 2019 - Jan 2022

Contracts Manager, Legal Affairs

• Nov 2016 - Jun 2019

Review and negotiate agreements to support critical business needs including research agreements (clinical and pre-clinical), collaborative research agreements and specialty pharmacy agreements. • Developed onboarding protocol to ensure new team members have access to critical systems and are able to quickly acclimate and contribute. • Manage relationship with contract lifecycle management system to ensure timely resolution of issues and implementation of system improvements. • Lead effort to identify and evaluate replacement global enterprise wide contract management systems to ensure work is done efficiently and transparently. • Develop signature delegation process to ensure delegations are documented and effectively communicated to procurement and legal professionals. • Mentor junior team members • Draft, negotiate and finalize agreements to support critical business needs • Created playbook and negotiation parameters for CDA and Regeneron Sponsored Registry study agreements and worked with the CRO to ensure timely and quality review of agreements Show less

Contract Specialist

• Oct 2015 - Nov 2016

Lead contractual negotiations with partners, collaborators, service providers, consultants and other vendors to ensure appropriate business and legal terms. Draft and track all agreements in appropriate systems and ensure on-time processing of all contracts from internal request to execution. • Trained internal business clients on signature policy and contract management system. • Managed heavy workload with increasing global component • Managed updated to contract negotiation playbooks. • Managed routine template review and updates. Show less

Contracts Manager

• Jul 2013 - Aug 2014

Draft and negotiate clinical research contrats and budgets and other related agreements. Draft and negotiate clinical research contrats and budgets and other related agreements.

Paralegal, Corporate Transactions

• Nov 2009 - Mar 2013

Provided legal and compliance review and negotiation support for confidential disclosure agreements, material transfer agreements, study agreements and research collaborations. Reviewed and summarized licensing agreements to support attorneys and for special projects. Supported special projects and assigned clients in Corporate Licensing and Business Development and External Scientific Affairs (preclinical research). Provided support for licensing transactions and completed regulatory filings as necessary including HSR filings and FINRA responses. Received an award of excellence in 2013 for the individual work performed on a specific HSR. • Led Hart Scott Rodino (HSR) Federal Trade Commission (FTC) filing for top licensing opportunity of 2013. This filing received FTC clearance in record time and the team was able to close the transaction sooner than anticipated. • Independently researched, designed and implemented a web query to collect data for the response to Financial Industry Regulatory Agency (FINRA) requests. The web query was user friendly and responses were received directly from high level executives including the CEO and General Counsel. Use of the web query minimized the impact on workload. Show less

Analyst/ Project Manager

• Mar 2008 - Dec 2009

Provided project management and other support to department as requested by Senior Directors and Assistant General Counsel.• Managed surveys to evaluate law firms on cost, quality and diversity factors. Presented survey results to senior leadership, leading to ongoing assessments of firms.• Led the implementation team for the transition to SAP in the Office of General Counsel (OGC), Global Communications (GC) and Global Public Policy and Corporate Responsibility (GPP&CR). This included identifying and addressing challenges to the implementation and ensuring appropriate resources were identified and employees were adequately trained.• Created and managed the Project Plan for the Merck and Schering Plough merger for OGC, GC and GPP&CR and represented these groups on the larger implementation team. Served as the contact to receive and share data requests and support the resolution of interdependencies. This led to receiving the Merck Divisional Award in 2009. Show less

Associate Manager

• 2005 - Mar 2007

Led the regulatory submissions team to ensure that quality documents were finalized on schedule to support research and marketing objectives. This included developing and communicating a submission plan with input from the team. Managed regular meetings to address concerns and challenges and make adjustments to the project plan as appropriate.• Submitted marketing applications worldwide to enable the sale of new products, updated approved marketing applications, and filed renewal documents allowing the continuation of selling products.• Prepared and submitted INDs in the US and CSAs ex-US that ensured clinical studies could begin on schedule and enable clinical research and development. Show less

Associate Medical Program Documentation Specialist

• 2003 - 2005

Supported clinical research team with study start up activities by providing documentation to the sites, negotiating consent form language with sites and ethics committees.• Performed as senior mentor for informed consent and authorization form program. One of two non-managers selected for this role in the early phases of the program. Ensured consent forms were reviewed and approved in a timely fashion to enable clinical research studies to enroll patients. Mentoring activities ensured colleagues developed the necessary skills to independently review and approve consent forms and increased the number of clinical research studies the group was able to support.• Led a team to re-engineer compliance and risk management program for study drug shipment approval. This reduced the cycle time for review and approval of clinical study drug shipment to clinical sites.• Designed and implemented an informed consent database to track consent form metrics and create a database to share language approved by either New Jersey or Pennsylvania site employees. This expedited the negotiation process and improved relationships with outside partners by providing consistent responses. Show less

Quality Control Specialist

• 2002 - 2003

Clinical Trial Assistant

• 2002 - 2002

Research Data Coordinator

• 2001 - 2002

CSR

• 1999 - 2001

Supported busy clinical practice and performed research with the medical staff.