Inclusively is partnering with a a global pharmaceutical company to hire a Legal Specialist. **Please note: this role is NOT an internal position with Inclusively but with the partner company.**

ABOUT INCLUSIVELY:

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ROLE RESPONSIBILITIES

Provide training to internal colleagues, contractors and CRO representatives on legal and process aspects of clinical trial contracting including supporting training on contract negotiation and escalation processes.
Maintain contract template and supporting comment and fallback materials and guidance documents including periodic updates of such documents.
Provide legal support for negotiations with external parties to achieve agreed provisions in various clinical study related documents including confidentiality agreements, interventional and non-interventional clinical study agreements, master clinical study agreements, CRADAs, clinical vendor agreements, medical grant agreements, Investigator-Sponsored study agreements and electronic medical records access agreements.
Provide first review of certain legal issues escalated to the Clinical Development Legal team from clinical teams, external clinical research organizations (CROs), medical grants teams, clinical vendor sourcing teams, local colleagues and other parties involved in clinical study activities.
Coordinate and consult with other roles as needed, including internal legal roles and individuals in regulatory, compliance, study management and government authority roles to assess risks and provide holistic legal guidance.
Work with legal counsel, study management and other colleagues as necessary to assess changes to global and local regulatory requirements as they relate to contracting templates, develop and implement practical, compliant updates to existing clinical trial legal related processes and documents.
Meet regularly with and maintain an efficient working relationship with internal colleagues and various CRO legal and contracting professionals to coordinate support, share information, provide guidance, identify emerging issues and coordinate proactive solutions.
Provide ad hoc support on special projects as needed.
Coordinate with administrative roles in maintaining team mailbox.

BASIC QUALIFICATIONS:

High School (HS) Diploma or GED
6+ years of legal department experience in the biotech/pharma, life sciences industry, law firm experience reviewing, analyzing and interpreting clinical study contracts and related documents
Must have the ability to read, analyze and interpret legal documents and to effectively present information to business partners and management.
Must have strong working knowledge of legal concepts and requirements related to clinical development contracts such as CSAs, and medical grants including Investigator-Sponsored agreements.
Must have proven ability to advocate for support of company positions in challenging negotiations with external parties.
Must be able to exercise independent judgment regarding legal and contractual matters within broadly defined practices and policies and be able work with relevant stakeholders to develop such practices and policies.
Working knowledge of clinical trial related legal, privacy, ethical and regulatory requirements including ICH-GCP and HIPAA.
Working knowledge of relevant complex legal/contractual concepts such as intellectual property ownership and indemnification.
Strong communication, problem-solving, and analytical thinking skills.
Ability to meet multiple deadlines, with a high degree of accuracy and efficiency.
Must have excellent organizational skills and attention to detail.
Must have excellent verbal and written communication skills.

PREFERRED QUALIFICATIONS:

Demonstrated ability to work with effectively with senior level law professionals.
Demonstrated ability to interact in a collaborative manner and at a professional level with clients at all levels throughout the organization and with external service providers.
Use initiative and discretion in accomplishing assignments with minimal supervision.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional flexibility in work non-standard hours to participate in meetings scheduled in other US time zones and international time zones. Occasional travel for team meetings.

Other Job Details:

Last Date to Apply for Job: December 9, 2024
Additional Location Information: Bothell, WA; Cambridge, MA; New York, NY
Work Location Assignment: Must be able to work from assigned office 2-3 days per week, or as needed by the business

The salary for this position ranges from $39.21 to $65.35 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Matching Contributions and an additional Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

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Legal Specialist