Ipsen

Medical writer

• Manage the preparation of a complex suite of regulatory documents e.g. protocols, CSRs, briefing documents, meeting requests, investigator brochures, clinical modules.
• Lead Writing/Editing complex Clinical Dossiers/Safety Reports.
• Review documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product within a clinical dossier.
• Plan and create timelines to produce assigned documents.
• Ensure proper planning and resourcing of all documents assigned to Writing/Editing Team.
• Actively contribute to best practices and continuous improvement within the therapeutic Area.
• Represent the group in functional and cross functional initiatives/projects when required.
• Network and share best practices to ensure efficiency and consistency across product teams.
• Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work.
• Adhere to the quality control process and ensure all work produced has gone through the correct internal review process.
• Maintain a working knowledge of pharmaceutical industry standards and compliance.
• Stay informed of upcoming projects, assist management in projecting resources, and perform administrative duties as requested.
• Identify and participate in the qualification of Medical Writing consultants and vendors, and oversee their writing activities to ensure timely and quality deliverables are completed within budget.

Medical Writer, Project Lead

Director

• Work in collaboration with the Asset Operation Lead (AOL), CMC functional lead, and Asset Team (AT) members
• Develop, implement and manage strategic project and CMC subteam plans
• Ensure a consistent project risk management methodology is applied
• Partner with CMC lead and functional reps to align with the Global Asset Plan
• Define interdependent subteam deliverables and manage quality, risk, cost, and time
• Drive execution of the workstream plan and monitor project plans
• Ensure decisions and actions at the subteam level are tracked in due time
• Actively manage changes and develop risk mitigation plans
• Support vendor selection and management

Director – Due Diligence and Integration

Account Executive

• Coordinate Ipsen resources at key target accounts to ensure all clinical, economic, access, educational support, and patient services information is made available to provider organizations.
• Focus access strategies for cross-functional account teams with various organizations such as Integrated Delivery Networks (IDNs), hospital systems, Acute Care Group Purchasing Organizations, Federal accounts, and Internal Provider Pathways.
• Establish and manage relationships with Pharmacy, C-Suite, D-Suite, Heads of Departments and Key Decision Makers (KDMs) in population Health to facilitate access.
• Ensure Ipsen products have parity or preferred coverage within accounts.
• Assist and collaborate with brand teams, V&A Verticals, Commercial Leadership in the development of brand strategies and business plans through market insights, data trends, customer protocols and processes.
• Create and lead pull-through strategies with field force to increase volume growth, market share and profitability through account specific business plans and execution with collaborative partners.
• Establish and maintain strong communication, collaboration, and coordination with all internal cross functional Ipsen teams.
• Develop, negotiate, and execute contracts with key accounts to maximize profitable access for Ipsen in both non-340B and safety net hospitals.

Corporate Account Director

QA Engineer

• Oversee qualification and ongoing quality oversight of service providers
• Lead service provider quality oversight meetings and ensure follow-up on actions
• Monitor and report on service provider quality performance
• Maintain quality agreements and ensure alignment with contracts
• Support audit and inspection readiness, including CAPA implementation
• Contribute to training and continuous improvement initiatives

Senior Clinical Vendor QA Specialist

Compliance

• Accountable for the strategy, tactics and implementation of all regulatory aspects of the assigned programs and all of its components for assigned region or worldwide.
• Provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned products/projects.
• Act as the interface between the R&D/Franchise/Operations and GRA on all regulatory issues relevant to Development and Product Maintenance activities within the assigned product/project.
• Ensure the development and flawless execution of regulatory strategies for the assigned products/projects and all of its components (both development and marketed products) for assigned region or worldwide.
• Responsible for having a broad perspective on external influencing issues as he/she may participate in external influencing activities with health authorities or trade associations, particularly those that would benefit from a broad perspective on Ipsen regulatory policy.
• Lead operational excellence initiatives within GRA

Manager, Global Regulatory Affairs

• Provide strategic input, oversight and coordination to ensure a streamlined and efficient approach to managed access and appropriate data capture across respective areas.
• Work closely with cross-functional teams to ensure alignment across Asset teams, Medical Affairs, Regulatory, Clinical Development, Market Access, and Supply Chain, while overseeing a team responsible for global execution and delivery of MAP initiatives.
• Collaborate with key partners (Medical Asset Leads, R&D TA Leads, legal, compliance, Country medical teams) to define and develop the managed access strategy for assets across multiple diseases TAs.
• Work with the Medical Asset Lead to define and execute the global Managed Access strategies across all therapeutic areas, ensuring alignment with Ipsen’s patient access vision and asset lifecycle plans and local affiliate requirements.
• Design, govern and implement Ipsen’s Post-Trial Access framework, ensuring ethical and compliant continuation of treatment for eligible patients.
• Own the global vendor strategy for Managed Access Programs, including selection, contracting, performance oversight, and renewal of service providers.
• Ensure clarity, compliance and execution of processes associated with Managed Access within the business, overseeing audit readiness, health authority reporting, and pharmacovigilance contributions related to MAPs.
• Lead development of a high-performing team to deliver excellence in execution to time and budget.

Senior Director, Managed Access – Global Medical Affairs

• Collaborate with the Ipsen Value & Access home office and field teams, sales teams, brand teams, and the IPSEN CARES Patient support hub to facilitate access by addressing barriers to Ipsen’s Rare Disease product portfolio
• Develop and manage communication channels with office staff at key accounts, including providers and specialty pharmacies, to facilitate patient access to Ipsen’s Rare Disease products
• Support processes for enrolling patients in Ipsen patient support programs
• Work directly with Patient Access Managers to resolve complex patient access questions in a timely manner
• Assist with the design and development of access-related strategies, tactics, tools, and approved materials for use in the field
• Clearly communicate available distribution options to HCPs, hospitals, and Integrated Delivery Networks (IDNs)
• Educate HCPs and administrative staff on the Medicare Part D benefit structure and latest changes, highlighting implications for Ipsen’s product portfolio
• Represent the Rare Disease Value & Access team and provide reimbursement and access support at professional conferences
• Increase awareness of, and work closely with the IPSEN CARES Patient support hub
• Collaborate with Patient Services on individual case management needs related to HCP education on access issues
• Serve as an internal field access expert with Ipsen’s teams (e.g., sales and account management) by providing ongoing competitive intelligence and by identifying access-related barriers
• Supporting appropriate patient access for all Ipsen Rare Disease therapies by providing timely and appropriate reimbursement information related to coverage and patient out-of-pocket costs across all payers relevant to a provider’s patient mix
• Coordinate with internal resources to support Ipsen presentations at pharmacy and healthcare conferences
• Achieve target metrics related to timely and appropriate response to customer requests for access support
• Support strategic analysis and planning related to changes in local payer coverage policies
• Advise Ipsen Account Teams of specific payer access challenges, and/or other access-related payer trends
• Assist in the development of access-related training programs for healthcare providers and administrative staff.

Field Access Director, Rare Disease

• Provide medical expertise and leadership in the design and implementation of clinical development strategies aligned with company objectives.
• Lead the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements.
• Provide study leadership and collaborate with cross-functional team members across the lifecycle of the study (i.e., design, execution, interpretation, and communication).
• Serve as medical monitor for clinical trials and to ensure adherence to ICH GCP, patient safety, and data integrity, in close collaboration with the CRO medical monitor.
• Provide medical expertise for interactions with regulatory authorities, including required regulatory documentation and responses to questions from global regulatory agencies.
• Build and maintain strong relationships with clinical investigators and thought leaders.
• Effectively fosters productive and collegial working relationships in a cross-functional, matrix environment with internal and external stakeholders.

Clinical Development Director

Project Manager

• Facilitate a cross functional CMC sub team, in charge of the set-up of clinical studies and which includes operational quality assurance, clinical packaging and distribution for internal projects and CDMO management for outsourced projects
• Represent GCSM within clinical study team meetings and ensure seamless alignment with clinical trials milestones (timelines, study design assumptions, recruitments assumptions etc)
• Develop strong collaboration with Global Regulatory Affairs and CMC Regulatory teams to ensure alignment of regulatory strategy (submission filing, product references to be used)
• Initiate and maintain risk assessment to minimize supply chain potential risks
• Track project performance, specifically to analyze the successful completion of short and long-term key goals (OTIF, forecasts KPIs, RFT etc)

Clinical Supply Chain Project Manager

Analyst

• Oversee day-to-day financial operations: internal audits, invoice tracking, purchase order creation, and contract renewals/adjustments.
• Act as the financial partner to GDIT leaders, ensuring cost governance, spend visibility, and budget adherence.
• Work closely with Finance Controllers and Procurement to support negotiations and secure contract alignment before signature.
• Analyse actual usage vs contracted services to identify optimization opportunities and advise technical experts during vendor discussions.
• Monitor, forecast, and predict financial flows, providing insights to avoid cost overruns and improve cost efficiency.
• Ensure strong financial governance by maintaining accurate data, tracking spend patterns, and recommending cost-saving levers.

Performance Analyst

• Work in collaboration with the CMC Lead, the Asset Operations Lead, and the Asset Team
• Develop, implement and manage strategic CMC roadmap
• Lead cross-functional CMC Subteam
• Monitor and track budgets and support resource management against strategic objectives

Global Project Manager

Risk

• Drive transformation and operational excellence across Global Portfolio Operations (GPO)
• Lead change initiatives and manage performance through robust KPI frameworks
• Ensure accurate KPI reporting and actionable insights
• Contribute to continuous improvement initiatives and project management
• Design and implement role-specific training plans and programs
• Provide support to the Head of Portfolio Operations & Governance Excellence on key business support activities

Manager, Portfolio Operations – Governance Excellence

Attorney

• Provide strategic legal advice and services across the full lifecycle of Ipsen’s oncology portfolio
• Act as a legal partner to global teams in Medical, R&D, and Product Strategy
• Support innovation while ensuring legal and regulatory compliance
• Provide strategic legal advice on global projects spanning multiple jurisdictions
• Draft, review, negotiate, and execute a wide range of contractual agreements