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Position Summary:

The Pharma Services Group (PSG) provides services for the pharmaceutical industry to develop new products and scale up to commercial volumes. PSG offers services to help develop products for both drug substance and drug product from pre-clinical to commercial manufacturing.

As a member of the PSG Legal team, the Lead Counsel, DPD-NA, is responsible for the delivery of high-quality commercial/business legal and compliance advice and transactional support to the Drug Product Division in North America (DPD-NA) and, as needed or requested, the Drug Product Division in the European Union (DPD-EU). This position reports to the Lead Counsel, DPD-Global.

The Lead Counsel, DPD-NA will provide front-line legal support for site operations throughout the DPD-NA network, currently comprised of Cincinnati, Greenville, Toronto, Whitby, Manati (PR), Bend and High Point. Also provide on as as-needed basis front-line legal support for site operations throughout the DPD-EU network. The Lead Counsel, DPD-NA will also:

• Sit on the DPD-NA business unit leadership team and attend LT meetings as appropriate. Provide general legal support and guidance to the BU-LT.
• Establish effective collaborative working relationships with the BU Leadership Team, Site Leadership Teams, Business Management, Project Management, Sales, and other functions, to provide timely advice on commercial/business/compliance legal matters as they arise.
• Establish collaborative working relationships with Division and/or Group Quality and Regulatory personnel in order to monitor quality performance and support matters arising from quality performance.
• Collaborate with PSG Commercial Legal and Contracts teams, Regional counsel, and corporate Functional counsel as needed for support on matters (recognizing the priority of PSG Commercial legal team is contracting).

Essential Duties and Responsibilities:

• Collaborates with PSG Commercial Legal and Global Contract Services (GCS) teams and other Group and Divisional counsel on commercial contracting policy development, including template development and updating.
• Supports and advises Group commercial/contracting attorneys and GCS on DPD aspects of commercial contracts.
• Manages certain key client relationships (e.g., Strategic Accounts) as assigned.
• Handles client disputes and litigation matters as assigned and in accordance with Corporate or Group escalation and approval policies.
• Provides advice as required to supply chain/sourcing, esp. with regard to liability gaps and chains, from vendor to client.
• Trains applicable employees/functions on contracting, compliance, and Thermo Fisher policies, as required.
• Ensures that DPD-NA conducts its business in compliance with all applicable laws and regulations and Thermo Fisher policies and guidelines. Liaises with applicable Thermo Fisher Functional legal and Compliance personnel
• Provides legal advice and guidance on a range of legal, regulatory and compliance matters, including pharmaceutical manufacturing (FDA and/or other agencies, cGMP, etc.), products liability, trade compliance, data privacy, etc.

Basic Minimum Qualifications (BMQ):

To perform this job successfully, the individual must be able to perform satisfactorily the following:

• Shown negotiation abilities and eye for business
• Familiarity with laws and regulations applicable to CMO operations (including GMP)
• Customer centric and solutions-oriented approach in supporting both external and internal clients while protecting the best interest of the company
• Experience managing contracts and legal professionals
• Experience developing, driving and implementing legal solutions
• Demonstrated ability to deliver strong results with limited resources, under tight deadlines and with a high degree of accuracy
• Strong oral and written communication skills
• Ability to maintain strict confidentiality of sensitive information
• Team player capable of leading and participating within cross-functional project teams to meet key milestones under tight timelines and stressful conditions
• Strong understanding of commercial and financial implications of business transactions and strategy development processes
• Self-motivated and require minimal direction to meet goals and objectives
• Strong interpersonal skills and effective communication and presentation styles.
• Strong work ethic with ability to work independently.
• Demonstrated commitment to our fundamental principles of Integrity, Respect and Excellence.
• Ability to manage time and challenging priorities including handling several assignments concurrently.
• Demonstrated proficiency with the latest MS Office products, including Teams, OneDrive, Outlook, Word, Excel, and related electronic tools for editing, documenting, tracking and communicating (including remote working).
• Occasional Travel required

Education/ Experience (BMQ):

JD (or equivalent law degree). Minimal requirements include at least 10 years experience as a licensed attorney, including substantive experience drafting, reviewing, revising and negotiating commercial contracts, strategic alliances and other business transactions, preferably in the life science sector. In-house experience preferred. Where applicable, familiarity with non-U.S laws and regulations for contracts performed outside the U.S.

Certificates and/ or Licenses (BMQ):

Applicable legal licensure and bar membership.

Internal Contacts:

Legal, Contracts Management, Commercial Operations (including, Sales, Quotes/Proposals, Business Management), Finance, Divisional Presidents, Divisional General Managers, Operations, Thermo Fisher Scientific Risk Management, and Quality.

External Contacts:

Customers / Suppliers /and their respective contract personnel and/or attorneys. Outside Counsel

Ability and/or Skills (BMQ):

Excellent analytical contract and business skills with above average oral and written

communications skills to support contract negotiations at all levels. Must be proficient in English.

Work Schedule:

8:00 AM to 5:00 PM core hours, additional hours as required. 10-25% travel.

Other Factors:

Considerable time line pressures require a sense of urgency and self-management.