Legal Senior Specialist

ROLE SUMMARY

Legal Senior Specialist primarily responsible for handling and managing a broad range of matters within the R&D Legal practice area including supporting the negotiation and drafting of agreements and other documents related to clinical development including informed consent documents. The individual will also assist clients and attorneys in this area advise on certain low and medium risk transactions and matters assist with R&D Legal portfolio management provide support for clinical development transactions and support implementation of practice area processes and digital tools.

ROLE RESPONSIBILITIES

• Provide legal support for negotiations with external parties to achieve agreed provisions in various global clinical study related documents including confidentiality agreements interventional and noninterventional clinical study agreements master clinical study agreements CRADAs clinical vendor agreements medical grant agreements InvestigatorSponsored study agreements and electronic medical records access agreements; use judgment to make decisions on matters of moderate complexity significance and/or risk.

• Provide first review of and advise clients on with limited manager supervision certain issues escalated to R&D Legal from Pfizer clinical teams external clinical research organizations (CROs) Pfizer medical grants teams Pfizer clinical vendor sourcing teams local Pfizer colleagues and other parties involved in Pfizer clinical study activities.

• Act as a subject matter expert within the practice area to advise R&D Legal colleagues other legal professionals and other Pfizer colleagues on R&D and clinical development issues; maintain strong understanding of relevant policies and processes and apply knowledge of same to complete assigned work.

• Maintain strong understanding of business needs and drivers relevant to R&D Legal practice area; provide technical expertise and/or training to internal colleagues contractors and CRO representatives on legal and process aspects of clinical trial contracting and informed consent documents including supporting training on contract negotiation and escalation processes.

• Manage and maintain contract templates and supporting comment and fallback materials and guidance documents including periodic updates of such documents.

• 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/portal; assist with creating and maintaining dashboards and other digital solutions for work management.

BASIC QUALIFICATIONS

• Applicant must have a high school diploma or equivalent plus 8 years of relevant experience; OR an Associates degree plus 6 years of relevant experience; OR Bachelors degree with 2 years of relevant experience; OR Masters degree. Relevant experience includes supporting legal transactions in the life sciences industry specifically supporting R&D transactions like vendor transactions and clinical site agreements.

• Expertise in drafting working on and negotiating contracts including confidential disclosure agreements vendor agreements clinical study agreements etc.

• Grounding in clinical development legal issues including Good Clinical Practice (GCP) informed consent and FDA/other biopharma regulatory compliance

• Experience with clinical development regulations and contracting (either in Biopharma or CRO context)

• 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.

• Effectively and efficiently prioritizes a dynamic workload

• Proven ability to handle projects with tight time frames; lead projects of low to moderate complexity and impact within practice area

• Advanced analytical research and problemsolving skills; apply experimentation and new ideas to solve problems

• Ability to coach counsel and advise colleagues at a similar level

• A collaborative and decisive working style that fosters cooperation

• An ability to properly balance the companys broader goals with each matters particulars

• Experience engaging directly with senior management opposing counsel and client groups; emerging ability to navigate matrix and influence key stakeholders especially within own practice area

• Demonstrated outstanding ability to translate complex information into high level concepts and communications for a range of audiences

• Selfmotivated extremely organized and solutionfocused

• Proven ability to rapidly build productive working relationships and thrive in new situations.

PREFERRED QUALIFICATIONS:

• Robust understanding of biopharmaceutical industry R&D processes and the external and internal business environment.

• Paralegal Certificate from an ABAaccredited school

• Familiarity with the Pfizer organization (or other relevant organization) particularly R&D/Enabling Functions.

• Strong interpersonal skills organizational maturity and ability to develop a network of trusted relationships with peers and other stakeholders.

• Possess a high energy level sense of urgency creativity decisiveness ability to work hard and well under pressure.

NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• Occasional flexibility to work nonstandard hours in order 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: May 6 2025

• Additional Location Information: Bothell WA; Cambridge MA; New York NY

• Work Location Assignment:Must be able to work from assigned Pfizer office 23 days per week or as needed by the business

The annual base salary for this position ranges from $80300.00 to $133900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer 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. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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