Senior Counsel – Regulatory
Location:
Posted:
October 14, 2016
Reference:
1602442
More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.

While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients' lives. If you are driven to create better health and a brighter future, join us!
OBJECTIVES:
Provide practical, timely, quality legal services to help the company meet its business objectives through deep understanding and compliance with laws, rules and regulations applicable to the company's businesses. This position may be assigned to a sub-specialty area within the Law Department.
ACCOUNTABILITIES:

  • Provide legal services for the company's business on a broad array of complex issues within the assigned Practice Category or subdivision thereof
  • Develop an assigned subject matter expertise regarding specific legal issues or areas within the assigned Practice Category
  • Manage and perform projects that involve complex or difficult issues requiring a high degree of original and constructive legal effort and business acumen
  • Provides immediate answers on complex issues from accumulated knowledge and experience
  • Establish rapport and a positive working relationship with business unit management and personnel at all levels to encourage and continue the proactive use of in-house legal counsel
  • Communicate with business colleagues at all levels in the organization regarding significant decisions, legislation and regulatory rulings that may affect the company's business or policy
  •  Collaborate with colleagues throughout Global Legal, including serving on Virtual Practice Groups as needed
  • Identifies training needs within the organization and develops and presents training materials on relevant laws and legal/business issues
  • Conduct or manage the conduct of research and the preparation of analyses concerning a broad range of federal and state legislation
  • May supervise work of external legal counsel
  • May lead other attorneys or paralegals on projects, as assigned by manager
  • Perform special assignments or projects, without significant supervision, as assigned by senior attorneys
  • Additional duties as assigned

ADDITIONAL ACCOUNTABILITIES SPECIFIC TO THE JOB:
  • Advise on all aspects of labeling and advertising to assure compliance with the FDA and FTC requirements, as well as foreign laws and regulation.
  • Provide legal advice to Takeda affiliates in the Americas and support Europe, Asia and Japan regarding regulatory issues relating to the affiliates' business operations.
  • Monitor developments in federal and state laws, regulations and industry guidance related to clinical, commercial and promotional laws, regulations, guidance and industry standards.
  • Work with Clinical Operations regarding legal regulatory issues including but not limited to review and assessment of Informed Consent Forms (ICFs), including pharmacogenomic elements, privacy authorizations, protocol deviations.
  • Assess and review all product labels, including label and CCDs creation and updates.
  • Work with Government Affairs and various outside trade associations, advising and reviewing responses to policy initiatives created by federal and state agencies (FDA, CPSC, Customs) and governmental bodies (Congress and foreign Ministries of Health).
  • Retain and direct the activities of outside counsel, where appropriate.



Qualifications EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Juris Doctor
  • A minimum of 7 years of experience in one of the following:  law firm or corporate law department; government agency; contract administration; risk management; other relevant experience
  • Pharmaceutical industry experience preferred.
SPECIFIC TO THE JOB:
  • Significant law firm or corporate legal department experience regarding all levels of pharmaceutical regulatory law.
  • Strong understanding of various federal and state laws regarding promotional, commercial and clinical conduct.
  • Proven ability to quickly understand and assimilate large amounts of detailed information and communicate in a concise manner to senior management
  • Scientific background is preferred.
  • Pharmaceutical industry experience is preferred.
LICENSES/CERTIFICATIONS:
  • Licensed to practice law - Illinois license preferable (other states considered).  Must receive Limited Admission as House Counsel in Illinois within one year of hire, if not already admitted to practice in Illinois.

TRAVEL REQUIREMENTS:

  • Domestic and international travel required, approximately 5%-25% travel.




we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.

*LI-TC1-USA

Schedule
Full-time
A little about us:
Takeda fosters an inclusive environment where all employees are empowered, supported and inspired to use their unique talents toward our mission to serve patients.

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