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Regional Medical Director UK Full-time · UK Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Regional Medical Director for the UK and Nordics region. About the role: The medical director is responsible for developing and executing the Medical Affairs strategy in the region. He is also in the lead of identifying, hiring and onboarding the field based medical team in his region. He needs to get involved in Digital Platforms and Real-World Evidence. The position is mainly focused on immunology with an existing marketed product and on novel therapeutic(s) for condition(s) to be marketed by Pharming. In close cooperation with upper management, the Regional Medical Director will prepare for a new product launch with a significant focus on internal and external disease and product education as well as critical reimbursement activities support. Although this position is working at a regional level, a large portion of the role will be focused on providing input and working closely with European (and Global) internal/external counterparts. The Medical director has a highly visible role in the organization therefore it is essential for this individual to have a strong leadership background as well as senior commercial, regulatory and market access insights. Areas of responsibilities: Management of the Medical Affairs team consisting of MSLs Working closely with upper management and other regional Medical Directors to implement and execute Medical Affairs strategy and operations at a regional level Coordinate regional interests with European (& Global) Medical Affairs and provide strategic expertise helping in driving global Medical Affairs strategies Assure cross functional engagement and collaboration, by partnering with the commercial, regulatory, market access and clinical development teams Build and develop the Medical Affairs team, formulating a medical affairs plan utilizing internal and external resources Medical leader for the current and upcoming launches, responsible for all pre and post launch activities Support creation of value dossiers and provide senior medical input in discussions with the national reimbursement organizations Involved in the implementation of Medical Affairs study activities covering all steps: from writing protocol, advising and coordination of progress of the studies as well as ensuring publications at the end of each project. Leading the regional expanding portfolio and life cycle management strategy responsible for integrating medical perspective into the responsible region. Required skills and qualifications in order to be successful in this role: Teamwork Scientific and business acumen Leadership Networking (cross cultural) Able to make an impact Strong communication skills Knowledge: Registered Medical Doctor Broad therapeutic background having worked across several different portfolio's, experience working with (ultra) rare diseases is advantageous In depth knowledge of operations in other departments such as clinical development, commercial, regulatory and market access Experience: Minimum of 8 years experience in the pharmaceutical industry Cross-cultural experience Demonstrated ability to influence and execute cross-functionally including external vendors to improve. Compliment and support internal team/performance Proven line management experience in a dedicated Medical Affairs function Strong experience in supporting reimbursement in the dedicated region, experience in remainder other regions is advantageous Proven experience of a successful launch of a rare disease product in the dedicated region (advantageous)
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Quality Specialist Full-time Leiden QA Officer Full-time Oss QA Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Finance Financial Reporting Manager Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss (Sr) Director Manufacturing, Science & Technology Full-time Leiden Junior F&E (Facility & Equipment) Engineer Full-time Oss Medical Affairs Regional Medical Director DACH Full-time DACH Regional Medical Director UK Full-time UK PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Regulatory Affairs (Senior) Specialist CMC Full-time Leiden Recruitment Corporate Recruiter Full-time Leiden ICT Servicedesk Engineer Full-time Leiden Functional Application Manager Full-time Leiden Sr. Servicedesk Engineer Full-time Warren, New Jersey USA Downstream Processing Downstream Processing Specialist Full-time Oss Procurement Director Procurement Full-time Leiden Bijgekomen; Regional Medical Director FR/BENELUX Full-time The Netherlands Regional Medical Director Iberia/Italy Full-time Spain Regional Director Medical Information and Communication Full-time The Netherlands Afgenomen: Aantal openstaand: 30 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 57 Vervuld: 39
Regional Medical Director FR/BENELUX Full-time · The Netherlands Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Regional Medical Director for the France/BENELUX region. About the role: The medical director is responsible for developing and executing the Medical Affairs strategy in the region. He is also in the lead of identifying, hiring and onboarding the field based medical team in his region. He needs to get involved in Digital Platforms and Real-World Evidence. The position is mainly focused on immunology with an existing marketed product and on novel therapeutic(s) for condition(s) to be marketed by Pharming. In close cooperation with upper management, the Regional Medical Director will prepare for a new product launch with a significant focus on internal and external disease and product education as well as critical reimbursement activities support. Although this position is working at a regional level, a large portion of the role will be focused on providing input and working closely with European (and Global) internal/external counterparts. The Medical director has a highly visible role in the organization therefore it is essential for this individual to have a strong leadership background as well as senior commercial, regulatory and market access insights. Areas of responsibilities: Management of the Medical Affairs team consisting of MSLs Working closely with upper management and other regional Medical Directors to implement and execute Medical Affairs strategy and operations at a regional level Coordinate regional interests with European (& Global) Medical Affairs and provide strategic expertise helping in driving global Medical Affairs strategies Assure cross functional engagement and collaboration, by partnering with the commercial, regulatory, market access and clinical development teams Build and develop the Medical Affairs team, formulating a medical affairs plan utilizing internal and external resources Medical leader for the current and upcoming launches, responsible for all pre and post launch activities Support creation of value dossiers and provide senior medical input in discussions with the national reimbursement organizations Involved in the implementation of Medical Affairs study activities covering all steps: from writing protocol, advising and coordination of progress of the studies as well as ensuring publications at the end of each project. Leading the regional expanding portfolio and life cycle management strategy responsible for integrating medical perspective into the responsible region. Required skills and qualifications in order to be successful in this role: Teamwork Scientific and business acumen Leadership Networking (cross cultural) Able to make an impact Strong communication skills Knowledge: Registered Medical Doctor Broad therapeutic background having worked across several different portfolio's, experience working with (ultra) rare diseases is advantageous In depth knowledge of operations in other departments such as clinical development, commercial, regulatory and market access Experience: Minimum of 8 years experience in the pharmaceutical industry Cross-cultural experience Demonstrated ability to influence and execute cross-functionally including external vendors to improve. Compliment and support internal team/performance Proven line management experience in a dedicated Medical Affairs function Strong experience in supporting reimbursement in the dedicated region, experience in remainder other regions is advantageous Proven experience of a successful launch of a rare disease product in the dedicated region (advantageous)
Regional Medical Director Iberia/Italy Full-time · Spain Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Regional Medical Director for the Iberia/Italy region. About the role: The medical director is responsible for developing and executing the Medical Affairs strategy in the region. He is also in the lead of identifying, hiring and onboarding the field based medical team in his region. He needs to get involved in Digital Platforms and Real-World Evidence. The position is mainly focused on immunology with an existing marketed product and on novel therapeutic(s) for condition(s) to be marketed by Pharming. In close cooperation with upper management, the Regional Medical Director will prepare for a new product launch with a significant focus on internal and external disease and product education as well as critical reimbursement activities support. Although this position is working at a regional level, a large portion of the role will be focused on providing input and working closely with European (and Global) internal/external counterparts. The Medical director has a highly visible role in the organization therefore it is essential for this individual to have a strong leadership background as well as senior commercial, regulatory and market access insights. Areas of responsibilities: Management of the Medical Affairs team consisting of MSLs Working closely with upper management and other regional Medical Directors to implement and execute Medical Affairs strategy and operations at a regional level Coordinate regional interests with European (& Global) Medical Affairs and provide strategic expertise helping in driving global Medical Affairs strategies Assure cross functional engagement and collaboration, by partnering with the commercial, regulatory, market access and clinical development teams Build and develop the Medical Affairs team, formulating a medical affairs plan utilizing internal and external resources Medical leader for the current and upcoming launches, responsible for all pre and post launch activities Support creation of value dossiers and provide senior medical input in discussions with the national reimbursement organizations Involved in the implementation of Medical Affairs study activities covering all steps: from writing protocol, advising and coordination of progress of the studies as well as ensuring publications at the end of each project. Leading the regional expanding portfolio and life cycle management strategy responsible for integrating medical perspective into the responsible region. Required skills and qualifications in order to be successful in this role: Teamwork Scientific and business acumen Leadership Networking (cross cultural) Able to make an impact Strong communication skills Knowledge: Registered Medical Doctor Broad therapeutic background having worked across several different portfolio's, experience working with (ultra) rare diseases is advantageous In depth knowledge of operations in other departments such as clinical development, commercial, regulatory and market access Experience: Minimum of 8 years experience in the pharmaceutical industry Cross-cultural experience Demonstrated ability to influence and execute cross-functionally including external vendors to improve. Compliment and support internal team/performance Proven line management experience in a dedicated Medical Affairs function Strong experience in supporting reimbursement in the dedicated region, experience in remainder other regions is advantageous Proven experience of a successful launch of a rare disease product in the dedicated region (advantageous)
Regional Director Medical Information and Communication Full-time · The Netherlands Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Regional Director Medical Information & Communication. About the role: The Director Medical Information and Communication develops the best-in-class medical information service, in cooperation with pharmacovigilance and commercial, and communication strategy for a transitioning biotech company in alignment with the brand plan, corporate and US communication needs. The director contributes to (pre)launch activities, e.g., like organizing conferences (pre-launch Leniolisib), establishes a medical information system and operationalizes the medical communication strategy, while building out the respective department as needed for current and additional products. Areas of responsibilities: Develops and delivers the best-in class medical information service, including related scientific writing, compilation and archiving of response materials whilst collaborating with existing medical affairs and pharmacovigilance team members to ensure compliance with regulatory guidelines Leads and manages the development and appropriate distribution of educational materials including internal and external medical training materials in collaboration with pharmacovigilance, regulatory and commercial stakeholders Leads and manages the development and appropriate distribution of educational materials including internal and external medical training materials in collaboration with pharmacovigilance, regulatory and commercial stakeholders Builds out the department for medical information and communication to ensure highest quality standards, while minimizing outsourcing costs as the product portfolio increases Works with client provided complex medical and technical information, able to present this clearly and proficiently in an audience dependent manner in order to optimize the product portfolio offering Leads the publication access and database management across EU&ROW in compliance with copyright requirements and other legal requirements as needed in order to consolidate the process across the company and ensure copyright compliance Leads the (pre-launch) conference management and related medical information needs post launch for current and new products Develops the medical communication strategy for EU & ROW in alignment with the brand plan corporate and US communication needs and manages the tactics in order to position the product(s) in a highly competitive environment Leads and delivers the product related training for both internal and external stakeholders to ensure scientific data and medical concepts are understood and consistent with the agreed strategic direction Required skills and qualifications in order to be successful in this role: Initiative Scientific and business acumen Stakeholder and people management Cultural awareness Strong communication skills Knowledge: Degree in medicine, PhD/PharmD (minimum qualification is a degree in Pharmacy or biological sciences) Ability to critically review scientific and medical information and develop balanced impactful standard response letters Excellent knowledge of the English language Experience: Minimum of 3 years experience within a Medical Information or Medical Communications role. Additional (line) management experience in other medical or non-medical functions within the pharmaceutical or biotech industry is strongly preferred. Highly experienced in Medical Information services responses across a number of therapeutics/therapy areas and related pharmacovigilance experience Prove experience in medical communication strategies and tactics Highly experienced in stakeholder management, building relationships and influencing both internal and external
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Quality Specialist Full-time Leiden QA Officer Full-time Oss QA Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Finance Financial Reporting Manager Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss (Sr) Director Manufacturing, Science & Technology Full-time Leiden Junior F&E (Facility & Equipment) Engineer Full-time Oss Medical Affairs Regional Medical Director DACH Full-time DACH Regional Medical Director UK Full-time UK PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Regulatory Affairs (Senior) Specialist CMC Full-time Leiden Recruitment Corporate Recruiter Full-time Leiden Senior Corporate Recruiter Full-time Leiden ICT Servicedesk Engineer Full-time Leiden Functional Application Manager Full-time Leiden Sr. Servicedesk Engineer Full-time Warren, New Jersey USA Downstream Processing Downstream Processing Specialist Full-time Oss Procurement Director Procurement Full-time Leiden Bijgekomen; Senior Corporate Recruiter Full-time Leiden Afgenomen: Aantal openstaand: 31 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 58 Vervuld: 39
Senior Corporate Recruiter Full-time · Leiden Pharming Group N.V. develops innovative therapeutics for the treatment of genetic disorders. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is growing quickly and as a result of this growth we are currently looking for a Senior Corporate Recruiter for the Talent Acquisition department in our Leiden office. About the role: As Senior Corporate Recruiter, you will liaise with in and external stakeholders for all Pharming's hiring matters. This includes attracting and hiring talent for Pharming vacancies, ensuring that Pharming’s mission, vision and culture is incorporated in the recruitment process and partnering with the business for short and long term hiring needs. The Senior Corporate Recruiter will take part in employer branding projects, ex-and internal recruitment activities and will act as a sparring partner for hiring managers, giving advice on all recruitment matters. Areas of responsibilities: Partner with and advise hiring managers to ensure an efficient and smooth talent acquisition process Partner with the business in strategic hiring projects Strategic use of LinkedIn and other candidate sourcing channels Provide an excellent candidate experience that incorporates Pharming’s culture and values Evaluate suppliers and negotiate contracts Participate and lead Employer Branding projects/Marketing activities Effective and timely sourcing of candidates for Pharming vacancies Monitor metrics to help optimize the recruitment process Monitoring of a large volume of vacancies and tight timelines Coordinate and plan talent acquisition activities Required skills & qualifications in order to be successful in this role: Strong communication skills Strong in building relationships/stakeholder management Pro-active Positive attitude Attention to detail Able to prioritize Knowledge and Experience: 5+ years work experience in a corporate recruiter position BSc. or higher in a relevant discipline (experience/affinity with Life Sciences is a major plus!) Fluent in both Dutch and English Experience in senior level stakeholder management Experience in hiring Medior/Senior/Management level positions (BSc. - PhD level roles)
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Quality Specialist Full-time Leiden QA Officer Full-time Oss QA Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Finance Financial Reporting Manager Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss (Sr) Director Manufacturing, Science & Technology Full-time Leiden Junior F&E (Facility & Equipment) Engineer Full-time Oss Medical Affairs Regional Medical Director DACH Full-time DACH Regional Medical Director UK Full-time UK Regional Medical Director FR/BENELUX Full-time The Netherlands Regional Medical Director Iberia/Italy Full-time Spain Regional Director Medical Information and Communication Full-time The Netherlands MSL Diagnostic Specialist Full-time The Netherlands PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Regulatory Affairs (Senior) Specialist CMC Full-time Leiden Recruitment Corporate Recruiter Full-time Leiden Senior Corporate Recruiter Full-time Leiden ICT Servicedesk Engineer Full-time Leiden Functional Application Manager Full-time Leiden Sr. Servicedesk Engineer Full-time Warren, New Jersey USA Downstream Processing Downstream Processing Specialist Full-time Oss Procurement Director Procurement Full-time Leiden Bijgekomen; MSL Diagnostic Specialist Full-time The Netherlands Afgenomen: Aantal openstaand: 32 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 59 Vervuld: 39
MSL Diagnostic Specialist Full-time · The Netherlands Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a MSL Diagnostic Specialist. About the role: The Medical Science Liaison establishes and maintains relationships with appropriate target physicians, researchers, and clinicians and key opinion leaders (KOLs) to ensure that products are used effectively. The Medical Science Liaison serves as scientific resource and expert, advises on current and upcoming advances in treatments, and provides input about relevant scientific and clinical data. He/she coordinates cross functional LCM strategies and executes medical affairs programs of therapeutic areas at local country (cluster) level. Areas of responsibilities: Develops and maintain long term relationships with local KOLs with a view to supporting IIT/medical project development in therapeutic areas of interest in line with local MA plan Provide in-depth medical scientific training and support to commercial (marketing and/or non-science) teams in the appropriate territories Utilizes field knowledge and insight to develop and support strategic and tactical objective of therapeutic area. Provides input to EU/US brand strategy Provide KOL insights and observations to the medical affairs team on a timely basis Help to ensure that KOL speakers have access to appropriate scientific data Participate in coordinating and conducting peer-to-peer interactions and medical presentations Remain up-to-date in appropriate therapeutic areas of focus to Pharming Provide medical support to Pharming’s clinical research programs and registries Provide overall medical / scientific support through the dissemination of on-label educational, scientific, and clinical information on diseases and its treatment, for training purposes only Develop relationships with local thought leaders (physicians, pharmacists and nurses) whose opinions and treatment regimens influence the practice of their colleagues Identify unsolicited requests for investigator-initiated research Disseminate to physicians, nurses and other healthcare professionals state-of-the-art on-label research and medical concepts related to the treatment and management of diseases of interest to the company Represent Medical Affairs at continuing educational events / programs, medical meetings and scientific conventions. Required skills and qualifications in order to be successful in this role: Networking Teamwork Persuasiveness Cultural awareness and sensitivity Strong communication skills Self-starter/independent Knowledge: Professional qualification; MD, PhD, PharmD Strong medical and scientific knowledge with experience of Immunology and/or specialty therapeutic areas advantageous Strong command of English language (verbal, written) and a second European language would be an advantageous (German, French, Spanish, Portuguese, Italian) Understanding of the ABPI Code of Practice/EFPIA guidelines (training will be provided) and in-country local code insight advantageous Experience: 3+ years of experience as an MSL 5+ years of work experience, preferably in the biotech/pharma industry Proven success working with local EU operating company models, processes, cultures, languages and functions
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Quality Specialist Full-time Leiden QA Officer Full-time Oss QA Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Finance Financial Reporting Manager Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss (Sr) Director Manufacturing, Science & Technology Full-time Leiden Junior F&E (Facility & Equipment) Engineer Full-time Oss Medical Affairs Regional Medical Director DACH Full-time DACH Regional Medical Director UK Full-time UK Regional Medical Director FR/BENELUX Full-time The Netherlands Regional Medical Director Iberia/Italy Full-time Spain Regional Director Medical Information and Communication Full-time The Netherlands MSL Diagnostic Specialist Full-time The Netherlands Medical Writer Medical Affairs Full-time The Netherlands PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Regulatory Affairs (Senior) Specialist CMC Full-time Leiden Recruitment Corporate Recruiter Full-time Leiden Senior Corporate Recruiter Full-time Leiden ICT Servicedesk Engineer Full-time Leiden Functional Application Manager Full-time Leiden Sr. Servicedesk Engineer Full-time Warren, New Jersey USA Downstream Processing Downstream Processing Specialist Full-time Oss Procurement Director Procurement Full-time Leiden Bijgekomen; Medical Writer Medical Affairs Full-time The Netherlands Afgenomen: Aantal openstaand: 33 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 60 Vervuld: 39
Medical Writer Medical Affairs Full-time The Netherlands Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Medical Writer Medical Affairs. About the role: The medical writer will conduct research into scientific studies and publications across the various product franchises and creates medical & scientific presentations/publications, for internal and external audiences, such as conferences, medical journals, as well as market access dossiers, based on scientific knowledge and applicable publication guidelines and legislation. Areas of responsibilities: Compile, write, and edit medical writing deliverables for presentations / publications for a broader audience, including scientific liaisons, healthcare professionals, and pharmaceutical representatives in line with the medical affairs and brand plan Write and review market access dossiers, such as reimbursement dossiers and health technology applications in line with the brand & commercial development plan Stay up to date with the scientific literature relevant for the Pharming product portfolio in order to position the product features for the optimized use in patients in any medical affairs communication Write state of the art publications for journals with highest impact factors (e.g., NEJM, Lancet, etc.) based on technical documents, such as clinical study reports Review and edit promotional material for internal and external audiences in order to ensure consistency across the medical affairs publications and communication tools Stay up to date for medical writing guidance and policies, whether international or national standards, as relevant for the publication. Required skills and qualifications in order to be successful in this role: Planning/organizing Teamwork/cross-functional Scientific acumen Initiative Strong communication/writing skills Self-starter/independent Knowledge: Master’s degree or PhD (strongly preferred) in (Bio)pharmaceutical Sciences, Biomedical Sciences, Biotechnology, Medical Biology or Medicine Ability to understand/process complicated scientific and/or medical information and write presentations, publications, dossiers in a clear and concise manner Thorough understanding of publication guidelines EFPIA and ABPI experience Excellent writing skills in English Experience: 3+ years of relevant medical writing experience Experience in writing/compiling medical presentations/publications
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Quality Specialist Full-time Leiden QA Officer Full-time Oss QA Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Finance Financial Reporting Manager Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss (Sr) Director Manufacturing, Science & Technology Full-time Leiden Junior F&E (Facility & Equipment) Engineer Full-time Oss Medical Affairs Regional Medical Director DACH Full-time DACH Regional Medical Director UK Full-time UK Regional Medical Director FR/BENELUX Full-time The Netherlands Regional Medical Director Iberia/Italy Full-time Spain Regional Director Medical Information and Communication Full-time The Netherlands MSL Diagnostic Specialist Full-time The Netherlands Medical Writer Medical Affairs Full-time The Netherlands PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Regulatory Affairs (Senior) Specialist CMC Full-time Leiden Recruitment Corporate Recruiter Full-time Leiden Senior Corporate Recruiter Full-time Leiden Associate Director Regulatory Affairs Full-time Warren, New Jersey USA ICT Servicedesk Engineer Full-time Leiden Functional Application Manager Full-time Leiden Sr. Servicedesk Engineer Full-time Warren, New Jersey USA Downstream Processing Downstream Processing Specialist Full-time Oss Procurement Director Procurement Full-time Leiden Bijgekomen; Associate Director Regulatory Affairs Full-time Warren, New Jersey USA Afgenomen: Aantal openstaand: 34 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 61 Vervuld: 39
Associate Director Regulatory Affairs Full-time Warren, New Jersey USA Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a Associate Director Regulatory Affairs (Labeling/Ad Promo). About the role: The Associate Director Regulatory Affairs (Labeling/Ad Promo)will be responsible for developing, implementing, and advising on labeling strategies for Pharming products in development as well as marketed products. This individual will manage regulatory labeling through all phases of development, and post-approval. The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met. The Associate Director, Labeling/Ad Promo Regulatory Affairs will also be responsible for overseeing the regulatory assessment and research on regulatory precedence, to evaluate advertising/promotional activities and materials. Areas of responsibilities: Provides high level strategic and operational regulatory direction on projects including, but not limited to general regulatory labeling strategies, requirements, and associated risk assessments Demonstrated thorough understanding of product labeling regulatory requirements in the pharmaceutical industry and healthcare environment, including policy trends Extensive regulatory experience leading and managing the development and maintenance of product labeling, and associated review processes externally as well as internally by managing the preparation and revision of regional labeling Ensure labeling content is accurate and in accordance with Health Authority requirements Provide regulatory leadership and guidance to the commercial and marketing team(s) during the development, review, and approval of product labeling and advertising materials Working with the regulatory operations team, prepares and submits appropriate ad/promo documentation to Health Authorities aligned with regulations Actively participates in the resolution of key regulatory issues from the labeling and ad promo perspective Works directly with the marketing teams from concept through review and approval, up to and including submissions Maintains awareness of global regulatory environment and assess impact of changes on business and product labeling activities Responsible for assisting with the development and implementation of regulatory processes from the labeling/ad promo perspective Required skills and qualifications in order to be successful in this role: Influencing Negotiation skills Teamwork Strong communicator/ability to present to Sr. Leaders & Health Authorities Cross-functional Collaboration Stakeholder management Knowledge: Bachelor’s degree in a life sciences or technical field from an accredited university; advanced degree preferred. RAC certification preferred In depth knowledge of U.S. FDA requirements for pharmaceuticals and biologics Experience: 5+ years related experience in Regulatory Affairs 5+ years of experience involving the direct implementation of promotional labeling in the biotech/pharmaceutical industry 3+ years of experience with advertising regulations; this must include experience providing regulatory input and evaluation as part of a promotional review committee.
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Quality Specialist Full-time Leiden QA Officer Full-time Oss QA Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Finance Financial Reporting Manager Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Junior F&E (Facility & Equipment) Engineer Full-time Oss Medical Affairs Regional Medical Director DACH Full-time DACH Regional Medical Director UK Full-time UK Regional Medical Director FR/BENELUX Full-time The Netherlands Regional Medical Director Iberia/Italy Full-time Spain Regional Director Medical Information and Communication Full-time The Netherlands MSL Diagnostic Specialist Full-time The Netherlands Medical Writer Medical Affairs Full-time The Netherlands PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Regulatory Affairs (Senior) Specialist CMC Full-time Leiden Associate Director Regulatory Affairs Full-time Warren, New Jersey USA Recruitment Corporate Recruiter Full-time Leiden Senior Corporate Recruiter Full-time Leiden ICT Servicedesk Engineer Full-time Leiden Functional Application Manager Full-time Leiden Sr. Servicedesk Engineer Full-time Warren, New Jersey USA Downstream Processing Downstream Processing Specialist Full-time Oss Procurement Director Procurement Full-time Leiden Bijgekomen; Afgenomen: (Sr) Director Manufacturing, Science & Technology Full-time Leiden Aantal openstaand: 33 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 61 Vervuld: 40
Quality Assurance Senior Quality Assurance Officer Full-time Leiden Quality Specialist Full-time Leiden QA Officer Full-time Oss QA Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Finance Financial Reporting Manager Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Junior F&E (Facility & Equipment) Engineer Full-time Oss External Manufacturing Manager Full-time Leiden Medical Affairs Regional Medical Director DACH Full-time DACH Regional Medical Director UK Full-time UK Regional Medical Director FR/BENELUX Full-time The Netherlands Regional Medical Director Iberia/Italy Full-time Spain Regional Director Medical Information and Communication Full-time The Netherlands MSL Diagnostic Specialist Full-time The Netherlands Medical Writer Medical Affairs Full-time The Netherlands PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Regulatory Affairs (Senior) Specialist CMC Full-time Leiden Associate Director Regulatory Affairs Full-time Warren, New Jersey USA Recruitment Corporate Recruiter Full-time Leiden Senior Corporate Recruiter Full-time Leiden ICT Servicedesk Engineer Full-time Leiden Functional Application Manager Full-time Leiden Sr. Servicedesk Engineer Full-time Warren, New Jersey USA Downstream Processing Downstream Processing Specialist Full-time Oss Procurement Director Procurement Full-time Leiden Bijgekomen; External Manufacturing Manager Full-time Leiden Afgenomen: Aantal openstaand: 34 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 62 Vervuld: 40
External Manufacturing Manager Full-time Leiden Pharming is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs. The company is poised for further scientific, technological and new product development and additional commercial roll-outs. The company is based internationally and growing quickly. As a result of this growth, we are looking for a External Manufacturing Manager About the role: The External Manufacturing Manager ensures that our manufacturing processes are fit for purpose and that Drug Substance (DS) and Drug Product (DP) are manufactured through our CMO (Contract Manufacturing Organization) partners for which (s)he owns the account. Aiming at delivering quality products through a reliable supply chain, the Manager ensures adequate process transfer from R&D, validation, continuous process performance to increase efficiency and robustness. Areas of responsibilities: Main point of contact for Manufacturing processes at multiple CMO’s To implement and validate Manufacturing related changes at CMO’s in order to develop scientifically sound processes and to keep them aligned with our own internal manufacturing process (if applicable) and ensure alignment between our DS (drug substance) and DP (drug product) processes To perform and report risk assessments of Manufacturing related topics at CMOs in order to minimize risks and balance efforts To ensure progress of assigned Manufacturing related projects (incl deviations, CAPAs and commitments to authorities) at CMOs in order to meet the timelines To be the spokesperson for Pharming wrt Manufacturing in case of regulatory audits at the CMO’s To perform Manufacturing related activities at CMOs according to the Pharming quality system in order to stay in compliance with cGMP guidelines To set up study plans, interpret/trend data and report results in final reports in order to have scientifically sound data to support the filing Represent MS&T-Manufacturing in multidisciplinary projects Keep up to date with new technologies and developments relevant to biotech/pharma industry Required skills and qualifications in order to be successful in this role: Problem analysis: connects different aspects of information to gain insight, questions (perceived) certainties to come up with solutions with the team Collaboration: actively contributes to a common result or problem solving, also when this exceeds the boundaries of the MST team Decisiveness: makes timely decisions, even if all information is not available, considering the consequences (risk-based approach) Creativity: searches for innovation and comes up with original ideas Persuasiveness: conveys his/her point in an impactful manner and achieves a positive result with a difficult proposition. States the common interest Oral and written communication: separating main issues from secondary issues and sharing information in a logical order Knowledge: Master's degree or PhD e.g. (Chemical) Engineering, Pharmacy, Biochemistry, Life Science & Technology, Biology Excellent understanding of manufacturing processes (biologics, small molecules), documentation requirements, systems and equipment Excellent understanding of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (EMA, FDA, ICH) Excellent verbal and technical writing skills in English (Dutch and French is an advantage) Experience: Minimal 10 years of working experience of which 7 years in the Pharma industry
Quality Assurance Quality Specialist Full-time Leiden QA Officer Full-time Oss QA Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Finance Financial Reporting Manager Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Junior F&E (Facility & Equipment) Engineer Full-time Oss External Manufacturing Manager Full-time Leiden Medical Affairs Regional Medical Director DACH Full-time DACH Regional Medical Director UK Full-time UK Regional Medical Director FR/BENELUX Full-time The Netherlands Regional Medical Director Iberia/Italy Full-time Spain Regional Director Medical Information and Communication Full-time The Netherlands MSL Diagnostic Specialist Full-time The Netherlands Medical Writer Medical Affairs Full-time The Netherlands PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Regulatory Affairs (Senior) Specialist CMC Full-time Leiden Associate Director Regulatory Affairs Full-time Warren, New Jersey USA Recruitment Corporate Recruiter Full-time Leiden Senior Corporate Recruiter Full-time Leiden ICT Servicedesk Engineer Full-time Leiden Functional Application Manager Full-time Leiden Sr. Servicedesk Engineer Full-time Warren, New Jersey USA Downstream Processing Downstream Processing Specialist Full-time Oss Procurement Director Procurement Full-time Leiden Bijgekomen; Afgenomen: Senior Quality Assurance Officer Full-time Leiden Senior Scientist Non-Clinical Development, Pharmacology Full-time Leiden Aantal openstaand: 32 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 62 Vervuld: 42
Quality Assurance Quality Specialist Full-time Leiden QA Officer Full-time Oss QA Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Finance Financial Reporting Manager Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Junior F&E (Facility & Equipment) Engineer Full-time Oss External Manufacturing Manager Full-time Leiden Medical Affairs Regional Medical Director DACH Full-time DACH Regional Medical Director UK Full-time UK Regional Medical Director FR/BENELUX Full-time The Netherlands Regional Medical Director Iberia/Italy Full-time Spain Regional Director Medical Information and Communication Full-time The Netherlands MSL Diagnostic Specialist Full-time The Netherlands Medical Writer Medical Affairs Full-time The Netherlands PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Regulatory Affairs (Senior) Specialist CMC Full-time Leiden Associate Director Regulatory Affairs Full-time Warren, New Jersey USA Recruitment Corporate Recruiter Full-time Leiden Senior Corporate Recruiter Full-time Leiden ICT Servicedesk Engineer Full-time Leiden Functional Application Manager Full-time Leiden Sr. Servicedesk Engineer Full-time Warren, New Jersey USA Downstream Processing Downstream Processing Specialist Full-time Oss Bijgekomen; Afgenomen: Director Procurement Full-time Leiden Aantal openstaand: 31 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 62 Vervuld: 43
Quality Assurance Quality Specialist Full-time Leiden QA Officer Full-time Oss QA Officer Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Finance Financial Reporting Manager Full-time Leiden Clinical and Medical Clinical Trial Assistant Full-time Warren, New Jersey USA R&D Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Junior F&E (Facility & Equipment) Engineer Full-time Oss External Manufacturing Manager Full-time Leiden Medical Affairs Regional Medical Director DACH Full-time DACH Regional Medical Director UK Full-time UK Regional Medical Director FR/BENELUX Full-time The Netherlands Regional Medical Director Iberia/Italy Full-time Spain Regional Director Medical Information and Communication Full-time The Netherlands MSL Diagnostic Specialist Full-time The Netherlands Medical Writer Medical Affairs Full-time The Netherlands Regulatory Affairs Medical Writer Full-time Leiden Regulatory Affairs (Senior) Specialist CMC Full-time Leiden Associate Director Regulatory Affairs Full-time Warren, New Jersey USA Recruitment Corporate Recruiter Full-time Leiden Senior Corporate Recruiter Full-time Leiden ICT Servicedesk Engineer Full-time Leiden Functional Application Manager Full-time Leiden Sr. Servicedesk Engineer Full-time Warren, New Jersey USA Downstream Processing Downstream Processing Specialist Full-time Oss Bijgekomen; Afgenomen: PMO Project Manager Full-time Leiden Aantal openstaand: 30 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 62 Vervuld: 44
Quality Assurance Quality Specialist Full-time Leiden Production Biotechnician Full-time Oss Animal Care Taker Full-time Oss Senior Biotechnician Full-time Oss Animal Caretaker Full-time Eindhoven Biotechnician Full-time Eindhoven Finance Financial Reporting Manager Full-time Leiden R&D Scientist Formulation Development Full-time Leiden Technical Operations & QC CQV Engineer Full-time Oss Junior F&E (Facility & Equipment) Engineer Full-time Oss External Manufacturing Manager Full-time Leiden Medical Affairs Regional Medical Director DACH Full-time DACH Regional Medical Director UK Full-time UK Regional Medical Director FR/BENELUX Full-time The Netherlands Regional Medical Director Iberia/Italy Full-time Spain Regional Director Medical Information and Communication Full-time The Netherlands MSL Diagnostic Specialist Full-time The Netherlands Medical Writer Medical Affairs Full-time The Netherlands Regulatory Affairs Medical Writer Full-time Leiden Regulatory Affairs (Senior) Specialist CMC Full-time Leiden Associate Director Regulatory Affairs Full-time Warren, New Jersey USA Recruitment Corporate Recruiter Full-time Leiden Senior Corporate Recruiter Full-time Leiden ICT Servicedesk Engineer Full-time Leiden Functional Application Manager Full-time Leiden Sr. Servicedesk Engineer Full-time Warren, New Jersey USA Downstream Processing Downstream Processing Specialist Full-time Oss Investor Relations Investor Relations Assistant Full-time Leiden Bijgekomen; Investor Relations Assistant Full-time Leiden Afgenomen: QA Officer Full-time Oss QA Officer Full-time Leiden Clinical Trial Assistant Full-time Warren, New Jersey USA Aantal openstaand: 28 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 63 Vervuld: 47
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