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Legal Staff Paralegal in Titusville, NJ

Janssen Research & Development, LLC (Janssen Pharmaceuticals, Inc) Aug 11,2020 Aug 06,2020 Location Titusville NJ
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In-House

Legal Staff

Corporate - Contract Law

Min 10 yrs required

Profile

Lead Regional Contract Manager Duties: Support creation and maintenance of contract templates in accordance with changes in laws, regulations, or corporate policies. Support creation and maintenance of fallback language and negotiation guidelines related to contract templates. Support training on contract templates and fallback language and provide training to first line negotiators and others as required. Provide specialized support and guidance on the negotiation of CTAs and CDAs to first line negotiators. Work with the legal department to create risk assessments to support the decision making process. Assess risks of legal terms and conditions independently and communicating them to stakeholders such as clinical team, law department, and internal team where appropriate. Provide guidance to 1st line negotiators, stakeholders and others as required. Lead negotiations on Master Agreements and custom templates or those requiring extensive modifications and identify potential risks to the business. Lead contract negotiations on terms and conditions of high-risk and complex agreements and other relevant legal documents as they relate to clinical trials and company/departmental policies. Coordinate with cross-functional departments to ensure consistency and compliance with process, external communications and policies. Assist in coaching/mentoring staff members. Liaise with all members of clinical team as needed in addition to representatives of investigator sites, academic research organizations, contract research organization, and site management organizations as directed. Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as determined by GCDO management as well as R&D companies, corporate, HCC and QA guidelines. Collaborate with internal stakeholders to ensure proper dissemination and management of knowledge. Monitor departmental processes to ensure compliance with corporate policies.

Qualification and Experience

Qualifications: Associate’s degree, paralegal certification or equivalent-type education is required. Paralegal degree, JD degree, LLM degree, or local equivalent is preferred. 6+ years’ experience with contract law in the pharmaceutical/clinical research industry and/or equivalent competencies in relevant fields with demonstrated ability to conduct contract negotiation, legal research and analysis is required. A working knowledge of the clinical development process is required. Fluency in English is required. Excellent oral and written communication skills and sensitivity to cross-cultural communication is required. Strong relationship management skills and experience is required. Strong ability to work across different geographic regions is required. Ability to work effectively across all levels of management is required. Strong and proven issue identification and problem resolution skills is required. Sense of urgency with ability to manage competing priorities while meeting deadlines is required. Working knowledge of PCs, MS Office, and database management are required. Business acumen and complex project management skills are required. Must demonstrate strong interpersonal and leadership skills with a strong drive to mentor and coach team members is required. Adhere to SOPs, ethics and departmental compliance as determined by JRP management as well as business partners, operating companies, corporate, HCC and QA guidelines are required. Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in resolution of site/study related concerns. Serve as a key liaison with management on staff performance and development. Facilitate clear and consistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results are required.

Additional info

Requisition ID: 9511200803

Company info