Director, Medical Information & Patient Safety

Ipsen•Cambridge, MA

5d•$225,000 - $330,000

About The Position

The Director, Medical Information and Patient Safety is accountable for providing comprehensive Medical Information support across assigned brands and therapeutic areas within the US, ensuring the planning, prioritization, and execution of all Medical Information deliverables. The role oversees the governance and direction of all activities related to the management of unsolicited medical information inquiries from healthcare providers, including leadership of the outsourced contact center, to ensure high quality, compliant, and timely responses. The Director also ensures robust oversight of in‑country patient safety requirements across all programs and serves as the central point of contact for US Medical Information and Patient Safety. In this capacity, the role works closely with partners across Global and US Medical Affairs, Regulatory, Legal, Local Quality, and Commercial to ensure alignment, compliance, and effective cross functional communication. The Director is responsible for identifying and addressing any deficiencies that could impact the Ipsen Medical Information or Pharmacovigilance system, implement corrective actions, and proactively monitor systems and processes within their remit to drive continuous improvement. The role is additionally accountable for ensuring that Medical Information and Pharmacovigilance insights are synthesized and shared effectively with relevant therapy area teams to inform strategy and decision making.

Requirements

12 years of related experience with a Master’s degree; or a doctorate (PharmD/MD/PhD) with 8 years’ experience; or equivalent experience.
10+ years of experience in a similar role or function within the pharmaceutical industry, including direct experience in Medical Information and Communications.
5+ years of proven managerial experience and skills in both direct and matrixed environments, including oversight of agencies and/or direct reports.
Extensive knowledge and hands‑on experience with Medical Information and Safety processes, with full compliance to all relevant requirements.
Ability to identify, assess, and recommend corrective actions for deficiencies that may impact Ipsen’s PV/MI system performance and/or compliance.
Expert-level proficiency in medical terminology and interpretation of medical and scientific literature.
Deep understanding of regulatory authorities, legal frameworks, and industry standards governing medical and drug information in the pharmaceutical/biotech sector.
Comprehensive knowledge of ICH guidelines, FDA Drug and Device regulations (including DDMAC), PhRMA Principles for clinical trial conduct and communication of results, and OIG Compliance Program Guidance for Pharmaceutical Manufacturers.
Results‑driven and solutions‑oriented, with a demonstrated record of achieving strong outcomes.
Positive, adaptable, and resilient, able to manage shifting priorities and competing demands with professionalism.
Strong project management, problem‑solving, and execution capabilities, with the ability to meet commitments and collaborate across multidisciplinary teams.
Able to work both independently and collaboratively, depending on organizational needs.
Excellent interpersonal and collaboration skills, fostering productive relationships across functions.
Highly skilled in time management, comfortable navigating complexity, adjusting to new circumstances, and operating effectively in a dynamic, fast‑paced environment with an entrepreneurial mindset.
Fluent in English.

Nice To Haves

Highly skilled in time management, comfortable navigating complexity, adjusting to new circumstances, and operating effectively in a dynamic, fast‑paced environment with an entrepreneurial mindset.

Responsibilities

Ensures management of all activities related to the handling of unsolicited medical information inquiries from healthcare providers through direct and matrix management, including: medical information contact center and system; Medical Information website; direction on the development, maintenance, and review of local response documents, and metrics and quality assurance reports; planning for US Medical Information support at medical booths for congresses held in the US (local and global); ensures compliance with all policies and SOPs via regular training.
Stays abreast of up-to-date regulations and best practices in medical information.
Drives process improvements and innovations including within digital channels and digital media, through collaboration with key internal stakeholders including Legal and Compliance departments.
Ensures awareness of upcoming milestones that will impact LRD database management plan.
Hires, mentors and develops Medical Information staff; establishes goals and performance metrics for and oversees performance and career development of staff; guides and supports staff for project-related matters and sharing of best practice.
Oversees regular and ad hoc metric and update reports for upper management and presentations within the organization; drives awareness and visibility of the US Medical Information department.
Acts as primary peer reviewer for USMI materials internal review process.
Effectively manages budget and resources (vendors and agencies) to meet short- and long-term objectives.
Develops Medical, Development, and Commercial relationships that provide valuable medical information knowledge and expertise sharing and participates in key meetings (e.g. congresses, scientific and medical meetings, and sales meetings) and business initiatives for assigned TA(s).
Supports the launch of new product(s) by ensuring that US Medical Information is represented on product launch teams.
Coordinates the support for Medical Affairs booths for priority scientific meetings and provides scientific data as requested.
Acts as Subject Matter Expert (SME) for internal and external audits for Medical Information to assure compliance and minimize business risk to Ipsen Biopharmaceuticals, Inc. in terms of regulatory violations and/or legal penalties, particularly those involving off-label topics, documentation of unsolicitation, dissemination of copyrighted material, and timely reporting of adverse safety or technical complaint reports.
Directs and participates in the development and maintenance of SOPs and job aids governing daily medical information practices at Ipsen Biopharmaceuticals, Inc.
Follows regulatory guidelines and Standard Operating Procedures (SOPs) pertaining to Medical Information, documentation and dissemination of information.
Interfaces with Global Medical Information colleagues to exchange medical information and best practices.
Participates in coverage for MI inquiry management after business hours, as appropriate.
Complies with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff.
Oversight of compendia and pathway submission strategy and execution, in alignment with Medical Strategy Teams.
Leads and fosters the development of the US Patient Safety Team.
Ensure affiliate has a comprehensive local PV system.
Ensure all PV activities are delivered in line with local guidelines, legislation as well as local and global Ipsen Policies and SOPs.
Escalate safety, compliance and operational issues to GPS/ QPPV in addition to the local Leadership.
Ensure the accurate, timely reporting to GPS and Health authority as applicable and follow-up activities of all adverse events and special situations reports and have necessary translation and quality steps in place.
Ensure compliance with PV requirements in all Company Sponsored studies (CSS), Investigator sponsor studies (ISS), Patient Data Collection Systems (i.e. Patient Support Programs, Market Research Programs, Early Access), and Digital Media conducted in the country by ensuring that PV expertise in the review and approval of these activities is provided.
Ensure that regular, documented audits of the local PV system take place.
Coordinate and input into deviations and CAPAs (Corrective Action and Preventive Action) where necessary.
Perform regular review of local Quality Documents such as SOPs and Instructions to ensure that they are compliant with GVP regulatory requirements and global Quality Documents as well as local regulatory needs as applicable.
Ensure that the PV team archiving is done in a timely fashion and in line with Ipsen SOPs and regulatory requirements
Ensures that pharmacovigilance training courses are provided and documented in compliance with local regulatory requirements and global/local SOPs for adverse event reporting on Ipsen products.
Coordinate and prepare regulatory authority PV inspections and internal affiliate country office audits and supporting the development of responses to findings.
Act as subject matter expert in inspections and audits and conducting audits as needed.
Work with the GPS and the country Leadership to ensure a PV Business Continuity Plan is in place and tested.
Provides after-hour coverage, as appropriate.