Ascendis Pharma

Manager

• Oversee key regulated activities including distribution, storage, import/export, promotion, medical information, and quality documentation.
• Support preparation and submission of regulatory documents such as variations and notifications.
• Support administrative efforts related to regulatory documentation (e.g., Certificado de Exclusividad).
• Ensure compliance with Spanish and Portuguese pharmaceutical laws and other local and EU regulations (GDP/GMP/GVP).
• Review and approve documentation related to pharmaceutical operations, distribution, and product handling.
• Ensure proper storage and transport conditions to maintain product integrity and patient safety.
• Ensure compliance with safety-feature requirements under the EU Falsified Medicines Directive (FMD)
• Support the implementation and continuous improvement of a fit-for-purpose local Quality Management System.
• Approve and follow up on SOPs, quality procedures, and training documentation.
• Participate in internal and external audits, including preparation and corrective actions.
• Manage deviations, complaints, CAPAs, and quality indicators.
• Contribute to supplier qualification and review of technical and quality agreements.
• Support annual product quality reviews and quality documentation activities.
• Support local pharmacovigilance compliance in collaboration with the global safety team.
• Report and follow up on quality and safety-related concerns as required by legislation.
• Act as the key point of contact for Spanish and Portuguese authorities (e.g., AEMPS, Infarmed).
• Ensure inspection readiness and support regulatory or quality inspections.
• Report quality defects, falsified medicines, and other safety-related issues according to Italy and EU regulations, in collaboration with local vendors.
• Work closely with local (and Global) Medical Affairs, Sales, Legal, Quality, Regulatory Affairs, Supply Chain, Compliance, and Finance.
• Provide guidance and support to internal teams on regulatory, quality, and compliance requirements.

Pharmaceutical Affairs Manager

Clinical Research

• For clinical trials: design, provide oversight, and support site and subject retention
• Ensure successful completion of documents (including clinical trial protocols, investigator brochures, monitoring plans, site training materials, clinical study reports, health authority responses, standard operating procedures, etc.) with cross-functional team members
• Participate on study teams and cross-functional teams as appropriate, and as delegated by the Vice President, Clinical Development
• Ensure consistent use of language and criteria across multiple endocrine projects
• Ensure study integrity, and track accumulating safety and efficacy data
• Anticipate obstacles within a clinical trial, and implement solutions
• Analyze, evaluate, and support accurate interpretation and reporting of clinical data
• Contribute to drafting and reviewing clinical documents, manuscripts, presentations, and regulatory submissions
• Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
• Collaborate with—and serve as a clinical research resource for—cross-functional colleagues to optimize product development
• Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company
• Support corporate strategic and organizational initiatives
• Assist with commercial activities as needed
• Complete assigned tasks thoroughly, accurately, and on time
• Adhere to rigorous ethical standards
• Travel up to 20% domestically and internationally for scientific meetings

Senior Clinical Scientist

• Support strategic publication planning activities, including participation in planning workshops and team meetings, preparation of meeting and workshop slides, and maintenance of publication plan documents
• Assist with maintaining electronic records for publication compliance
• Develop and maintain knowledge of Ascendis therapeutic areas
• Manage journal and conference submissions
• Provides copy-editing and QC of publications for accuracy, typos, and grammar, etc.
• Maintain database records, contacts authors, and attends calls with external parties
• Track internal and external deadlines for conference submissions
• Track progress of content development for multiple projects
• Maintain templates and process documents
• Support the development and maintenance of core publications guidance documents and templates
• Facilitate copyright transfer agreements and requests for reuse permissions relating to publications
• Coordinate printing and shipping of posters for congress presentations
• Other duties as assigned

Manager, Global Publication Planning

Marketing Operations

• Drive operational excellence across global marketing initiatives
• Standardize workflows for global marketing initiatives
• Define Global Brand Team processes: scope, compliance, cadence, and roles
• Deliver brand plans and frameworks for lifecycle management
• Outline and document annual brand plan deliverables and localization tools
• Manage Tier 1 congress planning with Meetings & Events, ensuring unified strategy and messaging
• Govern PromoMats and content repository access, training, and workflows
• Create and maintain localized brand plan templates and global repository
• Enforce global brand standards across all deliverables
• Oversee agencies and budgets, driving ROI and meeting quality/timeline targets
• Build team capabilities through hiring and transitions
• Lead stakeholder communications to clarify objectives, benefits, and progress

Associate Director, Marketing Operations

Director

• Serve as the driver of the development of the global strategic publication plan for one or more rare disease therapeutic areas.
• Oversee the planning, execution, and amplification of scientific publications, including abstracts, posters, oral presentations, manuscripts, and publication extenders.
• Collaborate cross-functionally to understand the medical communications needs across the organization.
• Represent the Publication Planning function across departments.
• Lead cross-functional teams to drive the development and rationale for the publication plan and strategic objectives for individual medical communications tactics.
• Interface with external experts and internal stakeholders to ensure publications address gaps and incorporate the latest data and expert perspectives.
• Oversee the tactical execution of the publication plan, ensuring high-quality, scientifically accurate, and timely publications.
• Develop and maintain expert knowledge of publication policies and procedures as well as industry regulations and guidelines.
• Contribute to department initiatives to improve publication practices and processes. Stay current on industry requirements and best practices.
• Write original content for publications, as needed.

Associate Director, Global Publication Planning

Data Analyst

• Manage commercial analytics efforts and shape go-to-market strategy through data-driven decision-making.
• Serve as a trusted thought partner to US commercial leadership.
• Translate complex data into actionable strategies that improve targeting, optimize sales execution, and inform launch planning.
• Play a pivotal role in shaping and mentoring a high-performing analytics team.
• Analyze secondary data (IQVIA, Symphony, Komodo, claims, EMR, SP data) to understand HCP behavior, patient journeys, market dynamics, and brand performance.
• Lead territory optimization and alignments, sales force sizing/design, incentive plan modeling, alignments.
• Inform customer segmentation, targeting, omnichannel engagement, call planning, and sales force deployment.
• Develop structured feedback mechanisms from field teams and synthesize qualitative insights into actionable recommendations.
• Partner closely with Sales, Marketing, Forecasting and Market research, Market Access, and Patient Services to ensure alignment between analytics and business needs.
• Provide strategic recommendations through KPIs, dashboards (Power BI), and other reports to track performance, identify risks, and optimize execution.
• Support brands by enabling data and insight-driven decision making through scenario modeling, forecasting inputs and competitive assessments.
• Present insights and performance monitoring results for senior leadership to influence and drive business decisions.
• Identify and implement new tools, technologies, and best practices to drive innovation in commercial analytics.

Director, US Secondary Data Analytics, Field Insights

• Responsible for driving regional market access, payer engagement, and implementation of national pricing and reimbursement decisions across selected Italian regions.
• Work closely with national Market Access, Medical Affairs, Commercial, HEOR, and Regulatory colleagues to ensure timely and sustainable access for patients.
• Focus on regional authorities, HTA stakeholders, hospital decision-makers, and payer bodies to secure adoption, formulary inclusion, and funding pathways for Ascendis’ therapies.
• Report to the Head of Market Access Italy and work field-based across Italy, with regular travel expected.
• Develop and execute regional access strategies aligned with national pricing and reimbursement decisions.
• Secure inclusion of Ascendis products in regional formularies, hospital budgets, treatment pathways and therapeutic plans.
• Translate national HTA outcomes into successful regional implementation across diverse regions.
• Lead regional negotiations and interactions with payers, regional authorities and decision-making bodies.
• Communicate clinical, economic and real-world evidence to regional stakeholders in collaboration with Medical Affairs and HEOR.
• Build and maintain strong relationships with regional health authorities, payer bodies, hospital administrators, KOLs and policy influencers.
• Partner closely with local and global teams to ensure integrated launch readiness and access execution.

Regional Access Manager – National Role

General Counsel

• Serve as the legal representative on the promotional review committee for Brand team.
• Provide legal advice to Brand team on relevant laws, regulations, and rules regarding promotional, advertising, HCP engagements and communications in relation to commercialization of biopharmaceutical products, marketed and investigational, including but not limited to the Food, Drug and Cosmetic Act; and implementing regulations promulgated by the FDA pertaining to drug labeling and the advertising and promotion of pharmaceutical products.
• Draft, negotiate and review agreements to support the Brand team, including healthcare professional consulting agreements, vendor agreements, and service agreements as delegated by legal contracts process.
• Ensure that Brand team operations comply with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulations.
• Support Global Medical contracts (US HCPs)
• Support US Grant contracts approved by the Grants Review Committee
• Support US Sponsorship contracts approved by the Sponsorships committee
• And other job duties that may be assigned. May be modified at any time as business needs require.

Assistant General Counsel, US Commercial & Medical

Marketing

• Lead the development of all payer-facing materials and customized access messaging to ensure the brand strategy is executed flawlessly across the entire access continuum. This includes creating actionable field and patient support tactics.
• Develop innovative, high-impact Patient Services tactics that optimize the end-to-end patient experience, specifically from prescription intake to achieving and maintaining therapy adherence.
• Lead the development and maintenance of all payer-facing materials, including promotional marketing assets, value decks, and resources to support payer account teams and their negotiations.
• Develop and execute "pull-through" and "push-through" initiatives to ensure product utilization once formulary access is secured.
• Create and maintain educational materials for Healthcare Professionals (HCPs) and field reimbursement teams that clarify product coverage, prior authorization criteria, and patient support options.
• Collaborate with brand marketers to align marketing tactics and share insights on payer and patient/caregiver needs and opportunities.
• Lead Medical, Regulatory and Legal Review of all market access and patient support promotional material, ensuring a high level of collaboration.
• Manage relationships with external agencies in executing payer and patient support tactics.

Associate Director, Market Access, Patient Support

Compliance

• Managing daily operational activities for regulatory submissions, including timeline management, scheduling, formatting, publishing, quality control, archiving, and submission to Health Authorities.
• Leading electronic publishing efforts for Investigational and Marketing applications to Health Authority Agencies worldwide.
• Collaborating with Global Regulatory Affairs and other functional areas to create submission project plans, trackers, and timelines.
• Preparing documents across all disciplines (e.g., CMC, nonclinical, clinical, regulatory) to meet global standards for electronic submissions.
• Supporting the use of templates and guidelines for regulatory documentation; provide formatting assistance and training to cross-functional team members as needed.
• Providing expertise in regulatory and technical submission requirements, including preparation, format, and structure.
• Serving as first-tier support for the Veeva RIM system.