Associate General Counsel - R&D and Technology (Hybrid - Warren)

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

The PTC Legal Teamstrives to be a valued partner to PTC's business,acceleratinginnovation andaccess to our medicines for patients in need, whilebalancing opportunity andriskin the conduct of our work.In every matter we handle, we strive to:

• Provide business-focused advice, solutions and support;
• Demonstrate a thorough understanding of the business;
• Anticipate challenges and remove obstacles;
• Communicate promptly, clearly andeffectively;
• Navigatethelegal landscape,identifying risks and formulating alternative pathways andsolutions; and
• Exemplify the PTCExpectations.

The Associate General Counsel - R&D and Technology is a hybrid position based in our Warren, NJ office, providing legal support for PTC's Technical Operations (chemistry, manufacturing and controls ("CMC") and supply chain), clinical operations, quality and IT functions. The role provides hands-on, day-to-day legal support and advice, and business partnership for PTC's technical operations, clinical operations, quality and IT 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 clinical trials and clinical 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

• IT: Legal support, including regarding data security, and contracts/engagements with vendors and other counterparties

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.

Responsibilities

• 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.

• Advises and supports the IT group on IT agreements and engagements, and legal issues surrounding intellectual property rights, information security and data protection.

• Drafts, reviews and negotiates 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.

• Performs other tasks and assignments as needed and specified by management.

Qualifications

• Juris Doctor degree and a minimum of [6] years progressively responsible experience, including at least [2] years of law firm experience and at least [2] years of in-house experience within a pharmaceutical, biotechnology or related environment, preferably supporting technical operations (CMC and supply chain), clinical operations, quality functions and information technology.

• 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; data privacy and information security; industry codes and guidance; and regulations and standards within the assigned region.

• Experience supporting technical operations (CMC and supply chain), worldwide clinical trials, information technology 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.

• Experience supporting an IT function, including surrounding intellectual property rights, information security and data protection.

• 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.

• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects and meet frequent deadlines.

• Travel up to 25%

Expected Base Salary Range:

$221,700 - 270,100 USD. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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