357064BR
Nov 24, 2022
Japan

Job Description

This position is responsible for providing: (1) legal leadership for the Global Drug Development Functions in Japan and regulatory legal support regarding Novartis’ products; (2) legal support to the department as center of excellence on all regulatory (pharma law) questions; including leadership and guidance for the Japanese Therapeutic Area (TA) lawyers in Innovative Medicines (IMI, AAA, GTx) and Sandoz in these matters. The incumbent will: (i) be a member of the GDD Japan Leadership Team and act as the primary Legal Business Partner/advisor for the Japanese GDD organization; (ii) provide strategic direction and leadership for all related legal matters; and (iii) be a member of the Japanese Legal Team.

Major Accountabilities


• Act as business partner for the Japan GDD Functions, responsible for providing strategic direction and leadership for all legal matters arising in GDD.

• Manage internal and external legal resources providing GDD/Regulatory legal support in Japan, plus matrix leadership beyond the Legal GDD team.

• Provide expert legal advice and support (regulatory and contractual) regarding clinical trials/studies with human beings, outsourcing of clinical trials to service providers and public institutions, Investigator Initiated Trials (IITs).

• Serve as the center of excellence for regulatory & development related legal issues, advising the lawyers in in the Therapeutic Areas (TAs), in particular regarding the regulatory frame-works in Japan, covering all development phases as well as quality related aspects (GCP and GMP). Provide legal regulatory advice and counsel to Country Legal Head and other Novartis attorneys relating to emerging areas of Japanese pharma law

• Build governance and interfaces between (i) GDD Japan; (ii) the Global Legal GDD function, and (iii) the regulatory, medical and commercial functions within Innovative Medicines, in order to ensure regulatory compliance and quality, considering inspections and investigations in the pharma sector.

• Active involvement in lifecycle management and regulatory legislative activities concerning Novartis Policy and Public Affairs and Regulatory Affairs.

• Advise on compliance-related matters, and assist in investigations, in the regulatory & development areas, working closely with the Country Head of ERC and the GDD ERC function.

• Active collaboration with global stakeholders as member of the Global Legal GDD team.

• Liaise with external Law Firms as necessary.

• Manage and resolve disputes between the Novartis companies in Japan and authorities re-lated to legal regulatory topics.

• Provide ad hoc support (remotely) to GDD Legal Team on projects/matters outside of Japan, as required.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Education
Law degree and bar admission in Japan or other jurisdiction
Educational background in science preferred

Language
Fluency in Japanese and English required

• Substantial expertise related to Japanese legal, policy, and regulatory environment (Pharma law).
• Understanding of both the Legal and Compliance view toward risk and regulatory issues.
• Min. 7 years of experience required: ideally gained within a healthcare / pharmaceutical environment (for example in a Pharma/Biotech company or Contract Research Organisation), or alternatively, with a top-tier law firm representing healthcare & technology clients
• Ability to analyse complex legal issues
• Strong verbal & written communication skills; together with a high ability to influence and negotiate
• Proven ability to work well under time pressure & with demanding teams
• Capability to handle a high volume of activity involving multiple, often complex, projects simultaneously
• Pragmatic, collaborative, culturally sensitive and business focussed approach
• Financial/business acumen preferred

Japan Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to midcareer[1][email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

To all recruitment agencies: This role is not open to additional recruitment agencies. The talent Acquisition Team will reach out directly in the timing of adding a new partnership. An Agency must obtain advance written approval from Novartis’ Talent Acquisition Team to submit resumes, and then only in conjunction with a valid agreement for service and in response to a specific job opening for which the Agency has been requested to submit resumes for. Novartis will not be responsible for any fees to any Agency that does not have a valid agreement.
PHARMA
Japan
Japan
Tokyo
Legal & Intellectual Property & Compl.
Full Time
Regular
No
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357064BR

Head Legal GDD Japan

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