Director, Senior Legal Advisor

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Prerequisites

1. Qualified lawyer with 12+ years experience, of which 5+ years of pharmaceutical law experience with a multinational pharmaceutical company or an international law firm.

2. Bilingual Japanese and English, written and spoken

Duties and Responsibilities

The International Legal Department serves the EMEA and Asia-Pacific regions (ex-Americas). The candidate would be a member of the International Legal department and would be responsible for ensuring effective legal support to the Celgene affiliate in Japan.

The candidate shall provide operational and strategic legal advice and shall proactively identify and support business needs in line with defined goals and objectives which will enhance operational effectiveness of the organization.

To fulfil the responsibilities of this role the candidate will work closely with the Japanese teams as well as the legal and other departments to support the business franchises and the functions within those franchises. At Celgene this would include in particular commercial, marketing, and medical departments. For certain projects the candidate would liaise with regional and global teams. In addition, the candidate would leverage the services of external counsel for matters where additional specific expertise is required.

The candidate shall also work closely with the compliance function to contribute to implementation of an effective compliance program including training and guidance that supports compliant practices according to corporate and local policies and procedures and which inspires a compliance culture within the organization.

The candidate shall be responsible for providing advice with regard to pharmaceutical laws and regulations in Japan as well as with FCPA and other international legislation and regulations that are applicable to international companies operating in Japan.

Previous experience related to the areas of responsibility will be required. Such responsibilities will include:

• Supporting clinical, pharmacovigilance and medical activities including company sponsored clinical studies, investigator sponsored studies, and post marketing studies in accordance with local and international requirements
• Distribution contracts for pre-approval access and commercial products
• Regulatory and contract law
• Advice regarding promotion and advertising (including promotional and scientific material)
• Training on relevant topics including differences between scientific communication and promotion, interactions with patient organizations and other policies and procedures
• Compliance advice related to engaging and interacting with HCPs and government officials in line with local and global standard
• Pricing and reimbursement negotiations in alignment with global pricing standards
• Data Privacy
• Advice and the ability to implement strategies with regard to Regulatory and IP protection (including anti-counterfeiting strategies, infringement actions and appeals in collaboration with external counsel and in-house IP teams)
• Supporting investigations as needed
• Monitoring of the Japanese legal and regulatory environment in order to ensure the organization is appropriately informed and trained on new laws and regulations applicable to the business

The candidate shall work autonomously, driving execution and being fully accountable to the business, while at the same time reporting to and coordinating with the International Legal Department and other relevant functions.

Candidate shall be an effective communicator both in English and Japanese, have strong leadership skills, and the ability to collaborate successfully with a variety of stakeholders throughout the global organization.

Skills/Knowledge Required

• Solid experience working with Japanese and International pharmaceutical laws and regulations and the ability to monitor new trends and changes in the law.
• Bar Qualified lawyer with 12+ years of post-qualification experience required, at least 5 years within a pharmaceutical or healthcare multinational company or a life sciences department of an international law firm.
• A law degree and working experience acquired in Japan and the US or Europe.
• Excellent written and oral communication skills in English and Japanese.
• Strong identification with Celgene’s values.