Merz Therapeutics

Operations

• Develop and implement strategies for operational excellence in alignment with the GMA vision
• Lead and develop the GMA Operations & Excellence team
• Optimize processes, workflows, and systems (e.g., Veeva MedInq, PromoMats)
• Drive digitalization and omnichannel projects as well as medical information services
• Design and deliver B2B training and establish a unified GMA training framework
• Ensure compliance, quality management, and audit readiness
• Maintain close collaboration with internal and external partners and with members of the GMA leadership team

Global Lead, Medical Affairs Operations and Excellence

Compliance

• Support regional regulatory strategies, approvals and life-cycle management of medicinal products, ensuring compliance with regulatory and legal requirements
• Review Company Core Data Sheets (CCDS)
• Implement CCDS into national product information texts (EEA/CH/UK), coordinate translations, and ensure compliance and timely delivery
• Initiate, review and approve artwork changes (EEA/CH/UK) in close cooperation with local Regulatory Affairs teams
• Support submissions and responses to regulatory authority queries
• Optimize labeling and artwork processes; train colleagues and act as a key user for Merz’s artwork management system
• Lead, monitor and further develop the Regulatory Intelligence process within global Regulatory Affairs

Regulatory Affairs Manager – Labeling and Regulatory Intelligence

Manager

• Responsible for achieving revenue and EBIT growth in the designated areas within the region EMEA through implementation of sales, marketing and commercial strategies.
• Involved in the optimization of commercial business with existing products, developing concepts and strategies to expand business with our partners and ensuring that new products and services are launched efficiently.
• Define, analyze and achieve annual budget targets.
• Carry out projects with regional representatives and partners to enhance business performance.
• Explore ways of improving existing products positioning and services including analysis of performance KPIs and competitor monitoring.
• Act as an interface between partners and Merz departments such as Supply Chain, Regulatory Affairs, Legal and Marketing.
• Leading, developing and controlling distribution partners including regular business reviews, changes on the Distribution Partner network and seeking new partners.
• Working on projects with third parties to enter new markets and launch new products.

Area Manager – Region EMEA

Communications

• Serve as the first point of contact for matters related to employee events, cultural initiatives, and overall well-being
• Plan and organize internal events and special projects that promote corporate culture
• Support colleagues by offering guidance and hands-on assistance to create an attractive workplace
• Assist the team with drafting, reviewing, and approving communication materials
• Help make the office an inspiring and pleasant place to work

Working Student – Global Communications

Bookkeeper

• Independent account coding and reliable processing of vendor invoices within the invoice approval workflow and in SAP
• Maintenance of vendor master data
• Processing dunning/reminder notices (both accounts payable and accounts receivable)
• Performing payment runs
• Independent processing of bank transactions
• Reviewing expense reports
• Reviewing purchase orders
• Assisting with month-end and year-end closings (financial statements)
• Contributing to and/or independently implementing process optimizations in accounts payable and accounts receivable

Accounting Clerk, 50-60%

• Develop and execute overall local marketing plans for the above-mentioned brands in cooperation with the Regional Marketing department and in close cooperation with Country Manager & Europe Marketing team Therapeutics.
• Execute 360° innovative (digital) marketing programs across various channels to build brands.
• Develop and execute the annual brand planning with a quarterly marketing activity calendar for the brands and contributes to the development and implementation of a communication strategy to build partner of choice position of Merz in Benelux.
• Work cross-departmentally (Medical, Sales & Operations) to develop strategies and implement projects that cover the market needs.
• Develop and manage brand budget, ensure optimal allocation, and monitor on a monthly base. Measure and analyze Return on Investment on each campaign. Identifies issues and opportunities.
• Facilitate and report competitive intelligence, monitor trends and activities, identifies issues and opportunities. Frequently conduct field rides to establish and conduct close contact with strategic top customers and local Opinion Leaders.
• Ensure communication and cooperation with external partners (e.g., agencies, suppliers, service providers) as well as their coordination within the framework of defined projects in consultation with the Country Manager.

Brand & Digital Manager

• Management of contract manufacturers – maintenance of supplier contracts (quality assurance agreements) as well as regulatory and manufacturing-related documents
• Support for the introduction of an established product at a new contract manufacturer
• Assist in the review and tracking of deviations, change requests, associated corrective actions (CAPAs) and complaints
• Contribute to projects aimed at improving efficiency
• Coordinate cross-functional topics and support the development of cross-departmental communication concepts and timelines
• Create process flowcharts and draft/format master documents and work instructions

Working Student – External Supplier Management, TX Operations

• Apply knowledge of global regulatory quality requirements to support the approval and maintenance of medicinal products
• Create, review, and update high-quality CMC documentation to obtain and maintain product approvals
• Support the preparation of IMPDs for clinical trial applications
• Implement change control processes, coordinate regulatory assessments, and maintain CMC submission and approval status
• Handle and manage inquiries related to quality documentation from regulatory authorities
• Oversee regulatory CMC projects and coordinate with Merz representatives and external partners
• Develop regulatory CMC strategies and represent regulatory requirements within project and interdisciplinary teams
• Maintain a detailed understanding of global and national CMC regulatory requirements and regulatory best practices

Regulatory Affairs Manager, CMC

• Achieve revenue and EBIT growth across designated territories within the EMEA region by implementing sales, marketing and commercial strategies.
• Optimize commercial performance of existing products by developing concepts and strategies to expand partner business and ensure efficient launches of new products and services.
• Define, analyze and achieve annual budget targets.
• Execute projects with regional representatives and partners to improve business performance.
• Identify opportunities to improve product positioning and service offerings, including KPI performance analysis and competitor monitoring.
• Develop concepts to expand the business through multiple routes to market and ensure efficient product launches and services for distribution partners.
• Act as an interface between partners and Merz departments such as Supply Chain, Regulatory Affairs, Legal and Marketing.
• Lead, develop and manage distribution partners, including regular business reviews, adjustments to the distribution network and identification of new partners.
• Collaborate on projects with third parties to enter new markets and launch new products.
• Provide guidance for implementation, and track roll-out and compliance.

Area Manager – EMEA Region

• Develop and implement global commercial excellence strategies to improve sales force effectiveness, customer engagement, and brand performance.
• Lead strategic initiatives to define the global framework for strategic brand planning and sales force effectiveness (targeting, segmentation, and territory alignment).
• Drive analytics, insights, and KPIs to support strategic decision-making and performance tracking.
• Strengthen launch excellence planning and execution for new products and lifecycle management for existing brands in close alignment with Regions and Affiliates.
• Collaborate with cross-functional teams and Regions/Affiliates to ensure alignment on commercial priorities and execution.
• Advocate for the use of digital tools and CRM systems to enhance field force effectiveness.
• Identify and implement best practices across markets and therapeutic areas.

Commercial Excellence Manager

QA Engineer

• Responsibility for quality assurance within the R&D departments at Merz Therapeutics
• Development and maintenance of systems and tools to support quality processes
• Quality management according to GCP and IT requirements (e.g., GAMP, 21 CFR Part 11)
• Planning and conducting audits, including reporting and CAPA tracking
• Support for quality- and IT-specific inquiries
• Ensuring compliance in global clinical development projects
• Preparation for and support during regulatory inspections
• Conducting GCP training as needed

Senior Quality Assurance Manager GCP

Content Writer

• Primary point of contact for the manufacturing site for the preparation and maintenance of regulatory documentation to support the compilation of regulatory dossiers
• Preparation of CMC documentation in accordance with internal requirements and in collaboration with the manufacturing organization
• Supervision of a Regulatory CMC Writing Manager including coaching, performance evaluation, ensuring compliance, and monitoring and driving performance improvement
• Review of draft documents with CMC Regulatory Affairs (CMC RA) and the respective site
• Conducting initial impact assessments and ensuring documented justification for changes
• Providing documentation in accordance with the LoQ (level of quality) and timelines, and coordinating related tasks with the manufacturing site
• Defining and coordinating the required information and documentation with the manufacturing site and contractors to meet established regulatory deadlines
• Supporting GMP inspections as needed
• Staying current with global CMC regulations and best practices

Team Lead, Regulatory CMC Writing

• Support regional regulatory strategies, authorizations and lifecycle management of medicinal products, ensuring compliance with regulatory and legal requirements
• Review Company Core Data Sheets (CCDS)
• Implement CCDS into national product information (EEA/CH/UK), coordinate translations, ensure compliance and timely availability
• Initiate, review and approve artwork changes (EEA/CH/UK) in close cooperation with local Regulatory Affairs teams
• Support submissions and responses to regulatory authority queries
• Optimize labeling and artwork processes; train colleagues and act as a Key User for Merz’s artwork management system
• Lead, monitor and further develop the Regulatory Intelligence process within Global Regulatory Affairs

Regulatory Affairs Manager, Labeling & Regulatory Intelligence

• Develop regulatory strategies and submission plans related to new registrations and lifecycle management
• Prepare high-quality documentation and execute necessary registration procedures while ensuring compliance
• Ensure and carry out the required regulatory activities to prepare and submit applications for new registrations
• Lead the development and maintenance of the Company Core Data Sheet (CCDS)
• Respond to regulatory authority inquiries
• Lead and coordinate regulatory projects and communicate with the relevant Merz representatives, partners, or consultants

Global Regulatory Lead – New Assets

• Lead a regional team, ensure regulatory compliance, drive performance, and optimize regulatory processes across licensing, budget and organizational structures
• Ensure local/regional input for global regulatory submissions and provide timely responses to regulatory authority requests in collaboration with global teams
• Maintain marketing authorizations/licenses and provide timely milestone updates to support global regulatory reporting
• Align regional input with global regulatory strategy and coordinate key interactions with health authorities
• Assess regional regulatory risks and opportunities related to product acquisitions
• Support departmental objectives, foster collaboration, and drive process improvements