Counsel, Clinical Vendor Contracts

1 month ago

King of Prussia Pennsylvania, Montgomery County, PA, United States CSL Behring Full time
The Opportunity:

Reporting to the Director and Lead Counsel, Global Clinical Legal, as the Counsel, Clinical Vendor Contracts, you will provide practical, timely, and high-quality legal support to the Global Clinical Development function of CSL, with a dedicated focus on Clinical Outsourcing, Chemistry Manufacturing & Controls (CMC), Clinical Trial Supply (CTS) and other groups as assigned. This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid

The Role:
  • In support of Clinical Development Business Operations, draft, review, and negotiate all clinical vendor agreements and provide legal advice with respect to issues associated with clinical vendor related matters. Provide subject matter expertise for legal issues associated with Clinical, CMC and CTS matters.
  • In support of other Clinical R&D client groups, review and negotiate vendor agreements as necessary for the engagement type.
  • Cooperate with other CSL legal teams, CSL’s procurement teams, and Clinical Business Operations to achieve aligned and efficient contract generation, review, and negotiation processes.
  • Manage the progress of clinical agreements in line with client needs and expectations.
  • Collaborate and coordinate with the Clinical organization to ensure proper information flow and follow up process with business partners.
  • Manage and maintain a current and effective global knowledge management/repository for clinical outsourcing agreements and templates.
  • Delegate work to Legal Services and Clinical Legal members as appropriate.
  • Advise on, and support, continuous development and improvement of process and workflow for Global Clinical Development to increase productivity and efficiencies for clinical outsourcing matters.
  • As assigned, provide legal advice and support in connection with non-routine special projects for Global Clinical Development or for strategic business transactions involving CSL Group affiliates, and for other matters or areas that business needs may dictate.

Your Skills and Experience:
  • Bachelor's Degree required.
  • Juris Doctor required or foreign equivalent.
  • Must be licensed to practice law in Pennsylvania or hold (or be eligible for and able to obtain promptly) a Limited In-House Corporate Counsel License under PA BLE Rule 302.
  • Minimum of 8 years practicing law, with 5 years of experience in a health care environment, preferably pharmaceutical or other organization engaged in clinical research.
  • Familiarity with global clinical development laws and regulations (including GCP/ICH), and health care regulations (including fraud and abuse, anti-kickback, and FDA) highly desirable.
  • Experience in an international environment, in-house or private practice, highly desirable.
  • Ability to proactively identify, analyze, and effectively explain potential legal risks and complex legal issues to clients and develop creative and business-focused advice and solutions to facilitate the business objectives of the company while effectively managing risk.
  • Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with client groups.
  • Strong drafting and negotiation skills required, as well as ability to produce quality work under pressure and while balancing multiple priorities.
  • Strong communication, analytical, project management, problem solving, interpersonal, and teamwork skills are required.
  • Team player, self-motivated, able to demonstrate a history of successfully resolving challenging legal issues, and ability to effectively deliver sound and clear legal advice in a business setting.
  • Strong proficiency with Microsoft Office Suite (particularly with Word, Outlook, Teams, One Note, and Excel).

Travel Requirements:

  • Periodic travel may be required, less than 5% of time.

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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