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Senior Legal Counsel - Medical Affairs

Employer
Ipsen Biopharmaceuticals, Inc.
Location
Cambridge
Start date
May 25, 2024

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Discipline
Clinical, Medical Affairs, Regulatory, Legal/Compliance
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Pharm Country

Job Details

Title:

Senior Legal Counsel - Medical Affairs

Company:

Ipsen Biopharmaceuticals Inc.

Job Description:

Senior Legal Counsel - Medical Affairs

Company Profile

Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company, focused on innovation and specialty care. At Ipsen, we’ve created a workplace that recognizes and promotes an entrepreneurial spirit in our employees, and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neuroscience, and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs.

We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer – the patient. This level of involvement by cross-functional teams promotes a strong sense of unity, and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe and Asia. As a growing organization, Ipsen North America is comprised of our United States and Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations.

Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we’re making hope a reality for the patients we serve.

Position Summary

The Senior Legal Counsel, Medical Affairs will serve as lead counsel to Ipsen’s 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 Ipsen 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 Ipsen.

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 Ipsen 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 Ipsen 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

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

The annual base salary range for this position is $177,000 – $266,000.

This job is eligible to participate in our short-term incentives program as well as our long-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Company

Ipsen (Euronext: IPN; ADR: IPSEY) is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen's North American operations and headquarters are located in Cambridge, Massachusetts, where our fully integrated biopharmaceutical team across External Innovation and Partnering, Research & Development (R&D), Manufacturing and Commercial collaborate. Cambridge is home to Ipsen's third global hub, in addition to R&D centers in Paris-Saclay in France and Oxford in the United Kingdom. With additional offices in Basking Ridge, N.J. and Mississauga, Ontario, Ipsen employs approximately 600 people in North America. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.

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Company info
Website
Phone
617-679-8500
Location
1 Main Street
Unit 700
Cambridge
MA
02142
US

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