Description:

Position Summary:
The Senior Legal Counsel, Medical Affairs will serve as lead counsel to A French Pharmaceutical Company Medical Affairs function. The Senior Legal Counsel will provide expert advice and counseling to the business on a broad array of strategic and tactical projects in this area within a highly regulated environment.

The Senior Legal Counsel is charged with counseling Medical Affairs regarding all relevant legal risks, including FDA guidance applicable to scientific exchange, appropriate communication regarding A French Pharmaceutical Company products (both approved and investigational products), activities implicating laws targeting fraud and abuse, as well as novel initiatives for which there may not be substantial precedent; this requires an experienced legal professional serving as a true business partner who can provide strategic legal counsel. Although Medical Affairs will be the primary area of responsibility for the Senior Legal Counsel, the Senior Legal Counsel will also have the opportunity to support other functions and initiatives within A French Pharmaceutical Company.

The position is diverse and demanding, requiring a broad range of experience, including in-depth experience counseling on promotional and non-promotional interactions with HCPs, federal and state Anti-Kickback Statutes, as well as the body of law, regulations and agency guidance relating to the development and commercialization of prescription drugs. It requires a desire to provide legal counsel across a growing and fast-paced, solutions-oriented organization. This role requires experience, good judgment, and flexibility in a highly regulated and compliant business.

The Senior Legal Counsel will be part of the North America legal team consisting of a General Counsel and eight other lawyers. The role will report to an Associate General Counsel, who reports to the Senior Vice President and North America General Counsel. The Senior Legal Counsel will work with all levels of employees, including senior management. This role provides the opportunity for visibility as a leader in the organization, as well as to engage with Ipsen's Corporate Legal Department in Paris, France on a wide range of issues.

While the Senior Legal Counsel will have significant professional support consistent with the A French Pharmaceutical Company Legal Team's culture and values, the role requires performance at a high level without substantial oversight or supervision. In addition, the Senior Legal Counsel will support transversal projects that are operationally critical for the company's continued growth as well as “special projects” that routinely arise outside of a particular attorney's job description and which provide additional professional development opportunities.

Essential Functions:
Responsibilities:

Responsibilities will include, but are not limited to, the following:

Provide primary legal support for the Medical Affairs function in the United States. In this role the Senior Legal Counsel will work closely with the SVP, Head of North America Medical Affairs and her team.
Provide timely and strategic counseling including complex risk assessments regarding ongoing or contemplated Medical Affairs activities.
Provide counsel regarding legal framework governing Medical Affairs interactions and activities, including but not limited to compliant scientific exchange and evidence generation.
Counsel commercial functions, including brand teams, on appropriate interactions with Medical Affairs.
Remain abreast of current enforcement trends in this area and ensure understanding of such by A French Pharmaceutical Company Senior Leadership.
Identify issues and collaborate with colleagues of all levels to find solutions to critical problems early in the strategic development process.
Strategize regarding cross-functional initiatives that remove barriers to legal compliance, design initiatives and process change around such strategies, create consensus as appropriate and drive North America Leadership Team dialogue and alignment.
Serve as a “coach” to the Medical Affairs team by going beyond helping them understand legal guidance for a particular project; support them in cultivating an ability to think through legal issues when planning for future initiatives.
Build a rapport with internal clients so that they understand you are “in their corner” while protecting the Company.

Qualifications:
Education:

Juris Doctor

Experience:

Active bar membership in good standing in Massachusetts or another state.
Significant experience providing counsel regarding Medical Affairs activities.
Significant experience and knowledge of pharmaceutical industry and rules and regulations related to development, distribution, sale, and marketing of pharmaceutical products (e.g., compliance with FDA marketing, advertising, and labeling regulations) and laws related to fraud abuse and prevention (Anti-Kickback and False Claims Act) is essential.

Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job)

A strong commitment to integrity and professionalism and demonstrated passion for excellence.
Genuine interest in all aspects of the pharmaceutical and biotechnology industry.
Ability to inspire trust and confidence through effective written and oral communication and interpersonal skills, including the ability to interface with, and gain the respect of, stakeholders at all levels and functions of the Company.
Ability to function independently; work proactively as well as collaboratively and cross-functionally and have excellent (internal) client interface skills.
Ability to communicate complex legal issues in a clear and understandable manner.
Ability to find appropriate balance between legal risks and the need of the business.
Excellent critical thinking skills and ability to analyze and understand complex situations.
Problem solver oriented towards finding practical solutions and providing practical guidance.
Strong work ethic and ability to manage large workload, multi-task, focus on critical priorities, and otherwise effectively meet client needs. Ability to produce high-quality work under deadline pressures.
Strong ability to grasp legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment and provide practical and constructive legal advice.
Significant Contacts

Internal – business partners; Corporate Legal (foreign parent)
External – outside counsel

Essential Functions – Physical Position Requirements: Machines and/or Equipment Used

PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Regularly required to operate standard office equipment (personal computer, photocopy machine, fax machine, etc.)
Ability to work on a computer up to 7 hours a day.
Regularly required to sit for long periods of time, and occasionally stand and walk.
Regularly required to use hands to operate computer and other office equipment.
Close vision required for computer usage.
Occasionally required to stoop, kneel, climb and lift up to 25 pounds.

Working Conditions:
Work independently; some travel required (including international).
Standard office environment without unpleasant or hazardous conditions. Work entails typical physical demands involved in office work.
Open workspace environment