SME - Legal - Pharmaceutical Life Sciences

Role Summary: Seeking highly qualified candidates for a subject matter Expert in Pharmaceutical industry within our Contracts, Compliance, and Corporate Services team.

Responsibilities and Duties:

- Carry out internal analysis of existing processes to identify the gaps and develop robust legal systems, processes, and SOPs for client and internal stakeholders.

- Build training materials and impart training to create a team of people who can review and negotiate contracts and ensure compliance with client guidance.

- Perform quality checks on team members' work product based on project guidelines and client instructions,

- Lead team for efficient delivery of drafting, reviewing, and negotiating contracts and other types of legal documents including, Clinical Trial Agreements, RFPs, LOIs, MOUs, NDAs, and any other regular business contracts.

- Lead negotiation on complex high-value contracts.

- Performing additional tasks and responsibilities assigned.

- Maintain personal records of work done.

- Contribute to process improvement ideas and actively participate in process improvement initiatives.

- Manage timelines and ensure SLAs (turnaround time, Quality) are met individually and on a team level.

Required Skills/Abilities:

- At least five (5) years working on Life Science legal and compliance-related matters.

- Expert understanding of State and Federal laws, regulations, and policies in relation to the pharmaceutical industry.

- Strong knowledge of the national business environment in which the client operates. Keeps current with evolving legal and business issues.

- Thorough knowledge of medico-legal liability provisions in pharmaceutical space.

- Ability to read and understand highly complex contractual language to identify and flag client risks and suggest mitigation in lieu of the client's playbook.

- Quick learner and adaptive to any process change in a minimal time period.

- Ability to comprehend questions and respond appropriately and professionally (writing and verbal)

- Knowledge of MS Office - including redlining and document comparisons

- Logical thinking and good decision-making abilities

- Proactive, works independently, self-learning attitude, disciplined, sincere, and needs less supervision.

- Responsible for compliance with ISO standards and other confidentiality

Education and Experience:

- Attorney or Legal Degree with 5-10 years experience in client management, contract negotiation, reviewing, and drafting.