Advises and supports the Technical Operations group on legal questions and issues, and on third party engagements.
Advises and supports the Clinical Operations towards compliance with clinical best practices and applicable regulation; drafts and negotiates clinical trial and vendor agreements for worldwide clinical studies.
Advises and supports the Quality group on legal matters and documentation related to quality, inspections and audits, and vendor engagements and agreements.
Drafts, reviews and negotiate agreements for internal functions and business partners in an effective, efficient and time-sensitive manner.
Provides timely and practical legal advice and support and identifies and resolves critical legal and business issues relating to internal operations and third-party engagements.
Plays a key role in building and driving a culture of compliance with business partners within the company, throughout the organization, and with relevant outside parties.
Perform other tasks and assignments as needed and specified by management.
Requirements
Juris Doctor degree and a minimum of 8 years progressively responsible experience, including at least 2 years of law firm experience and at least 5 years of in-house experience within a pharmaceutical, biotechnology or related environment.
Licensed to practice law in New Jersey, a US state, or eligible to obtain a limited in-house license in New Jersey.
Demonstrated knowledge and understanding of life-science/pharmaceutical regulations and industry guidance relating to the conduct of clinical trials worldwide; quality matters; industry codes and guidance; and regulations and standards within the assigned region.
Experience supporting technical operations (CMC and supply chain), worldwide clinical trials, teams and/or quality matters.
Experience supporting a quality function, including legal issues relating to quality documentation and hands-on support through regulatory audits / inspections.
Demonstrated leadership and management of legal issues and processes.
Exceptional interpersonal skills and excellent oral and written communication, ability to communicate effectively in a complex organization, and ability to influence without direct authority.
Demonstrated ability to combine a high level of energy and a strong work ethic with a commitment to continuous improvement in a dynamic environment that strives to exceed expectations.
Excell
Additional Information
PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team , fostering a strong sense of belonging.
Visit our website to learn more about our company and culture!
Site: www.ptcbio.com
Job Description Summary:
The Associate General Counsel - R&D/Tech Ops is a hybrid position based in our Warren, NJ office, providing legal support for PTC's Research & Development ("R&D") functions including drug discovery and development, clinical, and quality, as well as Technical Operations (chemistry, manufacturing and controls ("CMC") and supply chain) ("Tech Ops"). The role provides hands-on, day-to-day legal support and advice, and business partnership for PTC's R&D and Tech Ops teams with support to other functions as needed, on a wide range of legal matters, including:
- Tech Ops: CMC and supply chain: strategic legal advice and vendor agreements and engagements
- Clinical: Worldwide pre-clinical and clinical trials and pharmacology: legal support, guidance and document review towards compliance with clinical best practices and applicable regulation; handling of clinical trial and vendor agreements for worldwide clinical studies
- Quality: advice, counsel and support regarding regulatory requirements, quality audits/inspections and quality documentation
This individual is also responsible for helping to ensure PTC's adherence to applicable laws, regulations, guidance and industry standards. This includes, without limitation, data privacy and protection, information security, anti-corruption, anti-kickback, privacy, fraud and abuse, anti-bribery and transparency laws.
He/She is a valued business partner who works cross-functionally with internal departments and external resources as required on legal issues, supports and identifies opportunities to advance the company's objectives, proactively identifies legal risks, engages appropriate key stakeholders around risk awareness and mitigation, and provides support to help identify and implement actions/outcomes which serve the business needs while ensuring compliance and mitigating risks as appropriate. This requires close collaboration with the internal business teams to ensure an understanding of their needs and to foster a trusted partners.
Job Description:
Ptcbio · - New Jersey