Randi Munk-Jakobsen Email and Phone Number
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Experienced Legal consultant with a demonstrated history of creating results in both the private life science industry and governmental institutions . My 5 key competencies are: 1. Strategic Leadership and PlanningCompetency: Developed and implemented long-term strategies in various roles, such as leading an intercultural health team at the Embassy of Denmark in Korea and creating departmental strategies at the Danish Medicines Agency (DKMA).Result: Successfully bolstered Danish export promotion, fostered government-to-government collaboration, and enhanced efficiency through strategic initiatives and LEAN methodologies.2. Project and Portfolio ManagementCompetency: Managed large-scale projects and portfolios, including global patent litigation cases and the establishment of the Center for Data Analytics within the DKMA.Result: Efficiently drove projects to completion, ensured robust protection of intellectual property, and implemented agile project management tools to optimize departmental operations.3. Regulatory and Public Affairs ExpertiseCompetency: Participated in key regulatory groups like Efpia's IPR group and the HMA/EMA Task Force on Big Data, and established strong government relationships.Result: Influenced policy changes, such as extending prescription privileges for depression medication in Korea, and provided strategic insights to senior management on regulatory affairs.4. Innovation and Business DevelopmentCompetency: Launched the Biotech Platform, conceptualized a regulatory innovation office, and developed anti-counterfeit strategies.Result: Facilitated collaboration between Danish and Korean biotech companies, resulting in signed contracts, and enhanced the company's defense against counterfeit products.5. Executive Reporting and CommunicationCompetency: Prepared and delivered detailed reports and presentations for boards and committees, supported senior management, and developed comprehensive business cases.Result: Enabled informed decision-making, strategic alignment, and effective risk management by providing clear and insightful reports on ongoing litigation cases and strategic initiatives.
Auh Innovation & International Affairs @ Aarhus University Hospital
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International Affairs ManagerAuh Innovation & International Affairs @ Aarhus University HospitalHinnerup, Dk -
Health & Life Science Diplomat & Team LeaderEmbassy Of Denmark In Korea Dec 2021 - Aug 2024Seoul, SydkoreaKey Responsibilities and Achievements:Leadership and Strategy DevelopmentLead an intercultural health team, devising a long-term Danish strategy within the embassy to bolster Danish export promotion and foster government-to-government collaboration.Danish-Korean Hospital AllianceFounder: Established an alliance comprising four major Danish hospitals and four major Korean hospitals.Objective: Facilitate innovative projects between Denmark and Korea to enhance hospital services and patient care.Export Promotion Concept DevelopmentThe Biotech Platform: Launched in 2023 to align with current political interests and future needs in Denmark and Korea regarding biotech and biosolutions.Initiatives: Connected Danish biotech SMEs with the Korean biotech ecosystem through webinars, masterclasses, and participation in biotech fairs in Korea and Europe.Outcome: In November 2023, five Danish biotech companies traveled to Korea, resulting in two companies signing contracts with Korean counterparts for further collaboration.Public Affairs and Government RelationsRelationship Building: Established strong connections with Korean government authorities to enhance collaboration at the government level and ensure direct access to lawmakers and officials.Influence on Policy: Leveraged G2G relationships to impact the agenda on the prescription of depression medication, advocating for broader prescription rights to benefit more patients. As a result, prescription privileges were extended beyond psychiatrists for long-term antidepressant use. -
Senior Legal Advisor And Team Leader, Data Analytics And InnovationLægemiddelstyrelsen (Danish Medicines Agency) Jan 2021 - Dec 2021København, Hovedstaden, DanmarkKey Responsibilities and Achievements:Innovation Strategy and Department CreationI wrote the strategy for establishing a new innovation department, focusing on selecting medical and regulatory topics, managing stakeholders, and mapping the stakeholder ecosystem.EU Innovation Network: Acted as the official representative for Denmark.COVID-19 Vaccine ProcurementProject Lead: Directed the negotiation and purchasing of COVID-19 vaccines through the EU Joint Purchase Steering Group.Coordinated vaccine information among Statens Serum Institute, Danish Health Authority, and the Ministry of Health.Estimated purchase costs and advised the Ministry of Health on contractual issues with vaccine suppliers.Legal and Contractual ExpertiseProvided legal advice on tender processes, contract negotiations, and research collaboration with Danish universities regarding health data.Big Data Task Force LeadershipProject Manager: I have led the HMA/EMA Task Force on Big Data since October 2017, driving the project with comprehensive stakeholder management.Developed recommendations for data sharing and data ethics as a member of the Policy, Training, and Communications subgroup, published in Q1 2020.Center for Data Analytics EstablishmentProject Manager: Spearheaded the creation of a Center for Data Analytics within the DKMA.Implemented agile project management tools, managed reporting and presentations, and set strategic, legal and political priorities.Regulatory Innovation Office DevelopmentConceptualized and launched a regulatory innovation office in March 2021.Conducted stakeholder analysis, resource mapping, and secured political and financial support.Established a cross-functional service unit with a clear purpose and resource allocation.COVID19Team Lead: Led a project group to oversee and internally register all pharmaceutical trials related to COVID-19 treatments and vaccine development, and reviewed over 750 registered clinical trials and studies. -
Project Manager And Special Legal Adviser, Medical Evaluation & BiostatisticsLægemiddelstyrelsen (Danish Medicines Agency) Dec 2017 - Jan 2021Københavnsområdet, DanmarkEstablishment of Data Analytics CentreProject Manager: Led the creation of a Center for Data Analytics within the Danish Medicines Agency.Deployed agile project management tools, managed reporting and presentations, and set strategic and political priorities.Handled internal and external stakeholder management and provided legal advice to the project owner.HMA/EMA Task Force on Big DataProject Manager: Directed the HMA/EMA Task Force on Big Data since October 2017, effectively driving the project forward with comprehensive stakeholder management.Policy Development: Developed and published recommendations on data sharing and data ethics in Q1 2020 as a member of the Policy, Training, and Communications subgroup.Regulatory Innovation OfficeConcept Developer: Created and launched a regulatory innovation office in March 2021 to provide early-stage regulatory assistance to researchers and developers.Conducted stakeholder analysis, mapped resources, and secured necessary political and financial support.Established a cross-functional service unit with a clear purpose and resource allocation, leveraging a broad range of expertise within the agency.COVID19Team Lead: Led a project group to oversee and register all pharmaceutical trials related to COVID-19 treatments and vaccine development.Reviewed over 750 registered clinical trials and studies, continuing the review process alongside publicizing.Managed daily screenings of domestic and international clinical databases and study databases on treatment solutions. -
Project Manager & Executive Assistant To Director, Pharmacovigilance And Medical DevicesLægemiddelstyrelsen (Danish Medicines Agency) Feb 2017 - Nov 2017Copenhagen, DenmarkKey Responsibilities and Achievements:Department Strategy Development and ImplementationStrategic Planning: Developed and implemented departmental strategy, including the creation of KPIs and local goals for units and the department as a whole.Productivity Tracking: Designed a strategy for tracking productivity and implementing LEAN methodologies to enhance efficiency.Partnerships and ContractsExternal Partnerships: Established partnership agreements and contracts with external partners and stakeholders to strengthen collaborations and support departmental goals.HMA/EMA Task Force on Big DataProject Manager: Directed the HMA/EMA Task Force on Big Data since October 2017, driving the project forward with members from various European medicines agencies.Focus: Mapped challenges and opportunities of utilizing big data as a regulatory authority.Legal and Senior Management SupportLegal Adviser: Provided legal support to senior management on various topics, including addressing and processing legal requests from the Ministry of Health.Business Cases and Presentations: Developed presentations and business cases for senior management to aid in decision-making and strategy development.Adviser to Senior management and director: Served as an adviser to the director, offering strategic and legal insights.Financial ManagementBudget Planning: Managed budget planning and preparation, including the development of an annual wheel for the department to ensure efficient financial operations.Process OptimizationOptimization Projects: Identified processes for optimization and initiated projects to enhance departmental efficiency and effectiveness. -
Trademark And Domain Name Counsel - Global TrademarksH.Lundbeck A/S Aug 2015 - Jan 2017ValbyKey Responsibilities and Achievements:Contract Negotiation and CompilationContract Management: Expertly negotiated and compiled contracts with suppliers and agents, ensuring favorable terms and compliance with legal standards.Senior Management SupportExecutive Support: Provided comprehensive management support to the Senior Vice President and leadership group, facilitating effective decision-making and strategic planning.Business Case and product developmentBoard and Committee Presentations: Produced detailed business cases and presentations for the Board of Directors and various committee meetings, driving informed decision-making and strategy alignment.Strategy Development and ImplementationInterdisciplinary Strategies: Developed and implemented interdisciplinary strategies, ensuring cohesive and effective execution across departments.Intellectual Property Projects: Led projects such as mapping existing trademark licenses and identifying the need for further licensing of intellectual property rights.Anti-Counterfeit Initiatives: Planned and implemented customs surveillance and other anti-counterfeit projects, establishing best practices, liaising with authorities, and creating a European network for knowledge sharing.Legal SupportInfringement and Compliance: Provided general legal support, including drafting cease and desist letters, offering legal counsel, and handling infringement suits to protect the company's interests. -
Executive Assistant To Senior Vice President, Corporate Patents And TrademarkLundbeck Jan 2012 - Aug 2015ValbyKey Responsibilities and Achievements:European Public Affairs CoordinationIPR Initiatives: Coordinated European public affairs initiatives within Intellectual Property Rights (IPR) across Lundbeck, ensuring alignment and strategic focus.Negotiation and Contract ManagementSuppliers and Agents: Skillfully negotiated contracts with suppliers, lawyers, and agents, securing favorable terms and protecting company interests.Executive Reporting and SupportBoard Presentations: Produced monthly reports and presentations for the Board of Directors and various committee meetings, highlighting ongoing litigation cases and associated risks.Senior Management Support: Provided strategic support to the Senior Vice President and leadership group, aiding in informed decision-making.Regulatory and Public AffairsEfpia IPR Group Participation: Actively participated in Efpia’s IPR group, reporting on public and regulatory affairs to senior management to keep them informed on key developments.Strategy Development and ImplementationInterdisciplinary Strategies: Developed and implemented interdisciplinary strategies, ensuring cohesive execution and alignment with organizational goals.Project ManagementPatent Litigation Analysis: Managed projects compiling and analyzing business cases related to patent litigation, assessing financial incentives for initiating litigation versus potential sales impact in regions with valid patents and generic competition. -
Legal Assistant – Ipr Launched Products, Corporate Patents & TrademarksH. Lundbeck A/S Nov 2008 - Jan 2012ValbyKey Responsibilities and Achievements:Global Patent Litigation StrategyLitigation Strategy Development: Developed and coordinated global patent litigation strategies, ensuring robust protection of intellectual property.Portfolio Management: Managed a portfolio of litigation cases, maintaining communication with local patent agents and lawyers to drive favorable outcomes.Regulatory and Public AffairsEfpia IPR Group Participation: Actively participated in Efpia’s IPR group, providing insights and reports on public and regulatory affairs to senior management to inform strategic decisions.Anti-Counterfeit InitiativesStrategy Development: Developed anti-counterfeit strategies and participated in European networking initiatives through the Pharmaceutical Security Institute (PSI), enhancing the company’s defense against counterfeit products.EU Patent ResearchResearch Initiatives: Conducted research on EU patent initiatives within the pharmaceutical sector, contributing to strategic planning and decision-making.Executive Reporting and SupportBoard Presentations: Prepared and delivered monthly reports and presentations for the Board of Directors and various committee meetings, detailing ongoing litigation cases and associated risks to support executive oversight and risk management.
Randi Munk-Jakobsen Skills
Randi Munk-Jakobsen Education Details
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Business Administration And Corporate Laws -
Randers StatsskoleMatematisk Student
Frequently Asked Questions about Randi Munk-Jakobsen
What company does Randi Munk-Jakobsen work for?
Randi Munk-Jakobsen works for Auh Innovation & International Affairs @ Aarhus University Hospital
What is Randi Munk-Jakobsen's role at the current company?
Randi Munk-Jakobsen's current role is International Affairs Manager.
What is Randi Munk-Jakobsen's email address?
Randi Munk-Jakobsen's email address is rm****@****ail.com
What schools did Randi Munk-Jakobsen attend?
Randi Munk-Jakobsen attended Aalborg Universitet, Randers Statsskole.
What are some of Randi Munk-Jakobsen's interests?
Randi Munk-Jakobsen has interest in Leadership, Blogging, Social Media, Gender Equality, Trademarks.
What skills is Randi Munk-Jakobsen known for?
Randi Munk-Jakobsen has skills like Intellectual Property, Patents, Trademarks, Corporate Law, English, Microsoft Office, Financial Reporting, Project Management, Pharmaceutical Industry, Strategi, Domain Name Management, Domain Name.
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