Unless otherwise indicated, each position offers compensation consisting of a base salary, bonus opportunity, and stock options, and relocation packages are available.

· Counseling Sales and Marketing on promotional activities, programs and materials

· Counseling Medical Affairs and Development on legal, compliance and contract issues related to clinical studies, publications and independent medical education

· Reviewing commercial pricing contracts and providing counsel on government pricing issues

· Counseling the Compliance Director and auditors, and assisting in the performance of compliance monitoring and audit activities and compliance-related employee investigations

· Participating on cross-functional teams

· Providing legal/regulatory training to internal clients

· Drafting and negotiating contracts

· Strong academic background and at least five years of experience with a law firm or an in-house legal department of a pharmaceutical, medical device or biotechnology corporation, with a substantive focus on food and drug law, Medicare fraud and abuse and pharma compliance issues. Experience with commercial pricing contracts and government price reporting requirements for pharmaceutical manufacturers is a plus.

· A client service orientation, strong written and oral communication skills, and the ability to multi-task

· Ability to negotiate effectively and foster collaboration and consensus

The AGC, FDA Regulatory will maintain a current in-depth knowledge
with respect to the law and will provide counsel to both internal and
external personnel involved with FDA Regulatory issues. He/she will
ensure compliance with standard terms of retention and other
requirements of outside counsel.

The AGC, FDA Regulatory will have in-depth knowledge of strategic
business values and objectives. He/she will exhibit sophisticated
business acumen and knowledge of the pharmaceutical and medical device
industry as well as knowledge of structure, operations and policies
relevant to respective areas of responsibility.

The candidate will be knowledgeable of laws, regulations and
administrative procedures associated with FDA regulation and require no
professional guidance. He/she will have highly effective analytical
problem solving skills and an ability to identify and address complex
legal and business issues.

In particular, the AGC, FDA Regulatory will:

1. Provide legal counsel for the development and administration of the
company’s strategy to gain and maintain regulatory clearance for
product introductions in the US and globally.

2. Identify and develop appropriate compliance and regulatory
strategies to ensure company-wide compliance with FDA and other
applicable federal, state and local laws.

3. Maintain primary contact with the FDA and other regulatory agencies as necessary.

4. Provide legal counsel for the development and administration of all
regulatory processes, procedures and systems and advise management
appropriately on all recommended actions.

5. Ensure proper steps are taken to maintain compliance with the FDA and other regulatory agencies as required.

6. Review federal legislation relating to the FDA and provide technical assistance to any legislative strategy.

7. Oversee the monitoring of regulatory, legal and scientific
activities at the FDA that affects company products including new
guidances, product approvals and Federal Register notices.

8. Interpret domestic and international regulatory requirements and
guidelines and make recommendations to management to ensure regulatory
compliance of new products, new features and capabilities introduced to
the market.

9. Provide advice to technical departments to determine the necessity
and proper scope of submission of information to the FDA, federal
agencies, and international agencies for new products and product
modifications.

10. Review and approve scientific and technical documents intended for submission to the FDA.

11. Review and approve all labeling, promotional materials and technical communications for commercial products.

12. Advise and assist on all phases of FDA litigation and pre-litigation, including activities related to outside counsel.

13. Formulate creative business-oriented strategies and solutions.

14. Provide monthly reports to Corporate legal leadership regarding
status of FDA submissions, etc., and communicate with corporate counsel
regarding regulatory matters directly related to the Segment.

15. Work effectively with the appropriate functional groups to solve
problems, including manufacturing and other issues which may require
decision making regarding product recalls and notifications to FDA.

Requirements

The AGC, FDA Regulatory should be able to act substantially without
supervisory guidance and will be able to demonstrate and exercise
creativity and initiative in solving problems.

1. At least six to eight years of experience with U.S. and
international regulatory practices, policies and procedures applicable
to pharmaceutical products, preferably with a major pharmaceutical
corporation or with the U.S. FDA or a department of a first tier law
firm focused on such areas.

2. Experience working with the U.S. FDA.

3. Excellent academic credentials, including a J.D. degree from a leading law school.

The position:

• Advises clients on promotional and regulatory (FDA and fraud & abuse) matters and reviews promotional materials and brand plans;

• Helps conduct legal and compliance training of both field and in-house employees; and

• Drafts, reviews and may negotiate commercial contracts, particularly confidentiality agreements, consulting agreements and clinical trial agreements.

This is an opportunity to join a very collegial legal department.

Transactional/ contracts experience is NOT necessary, as the company is willing to train the successful candidate with the appropriate regulatory background on contracting matters.

Pharmaceutical company seeks Counsel/ Contracts Attorney. The
successful candidate will have primary responsibilities for management of contracts
for the company's discovery and development departments, including drafting and
negotiating of CDAs, NTAs, consultant agreements, and other commercial
contracts. Must demonstrate experience in general corporate matters, including
corporate organization, securities compliance, drafting transactional
documents, license agreements, employment law, risk management, and contract
management.

JD plus 2-5 years experience in-house or at a major law firm.
In-house experience not required. Must be able to work as a team and
independently with the exercise of good business judgment.

* Evaluate and manage the company's e-discovery preparedness project and make recommendations to senior management on a uniform approach to responding to e-discovery requests in litigation matters

* Evaluate and make recommendations regarding document retention function for all departments in the company

* Participate in developing a global enterprise risk management strategy for all the company's organizations and assist in implementing the same

* Provide advice on various legal matters including federal and state laws pertinent to drug safety activities, FDA regulations, compliance, fraud & abuse, product liability and other liability matters, dispute management and resolution, risk management in global operations and on a day-to-day corporate affairs/activities

* Provide legal advice to Sales and Marketing teams on a wide variety of advertising and promotional activities related to the company's products

* Legal representation on cross-functional and potentially cross-organization teams; this may include coordination with attorneys at domestic and overseas affiliates

* Interface with clients in various departments and seamless assimilation into and cooperation with the colleagues on Legal team

* Interface with co-promote counterparts

* Experience in advising on pharmaceutical law and knowledge of the industry

* Prior in-house experience in industry preferred

* Knowledge of FDA regulatory, GCPs, fraud and abuse, and privacy (HIPAA) and results disclosure issues preferred

* Experience supporting Sales and Marketing function experience preferred

* Strong writing, speaking organizational and analytical skills; interest in participating in diversified, fast-paced, multidimensional pharmaceutical law practice with significant contracting and counseling work

* Able to identify and research legal risks and issues and effectively counsel clients

* Able to conduct education presentations on legal and regulatory matters

* Able to facilitate communication among and education of clients regarding the impact of law and regulation on business operations