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QA Officer Full-time Oss 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 Quality Assurance Officer in Oss. About the role: The QA officer ensures that the quality system at Pharming, external partners and contractors is compliant with EU and USA GMP legislation, guidelines and/or Pharming quality expectations. He or she evaluates, analyzes and prepares pharmaceutical related documents needed for batch release and compliance to GMP. Areas of responsibilities: Write, implement, review and maintain SOPs, policies and other QA related documentation. in alignment with applicable GxP guidelines. Identify documents which need to be created or updated and ensure this is organized. Act as co-trainer and expert for other Quality Assurance Officers. Organize meetings with BME and/or Pharming departments to ensure problem resolution and conducting investigations associated with deviations, Change Controls, and CAPA’s. Review, analyze and prepare documentation related to commercial starting material production, including batch records, specifications and certificates to ensure compliance with applicable guidelines and procedures. Identify and communicate areas for improvement. Propose ideas for site improvements. Preparing and supporting internal and external audits in relation to applicable guidelines (like GMP, GLP, ISO, GDP, GCP). Required skills & qualifications in order to be successful in this role: Decisiveness Communicative Responsible Quality oriented Teamwork Problem analysis Behavioral flexibility Knowledge: Education: BSc. Biotechnology, chemistry, biopharmaceutics or equivalent Technical skills: Extensive knowledge of and experience with GMP regulations for EU and US. (like GMP, GLP, ISO, GDP, GCP) Experience: Four years of experience in (bio)pharmaceutical environment with at least one year in Quality Assurance.
QA Officer 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 Quality Assurance Officer in Leiden. About the role: The QA officer ensures that the quality system at Pharming, external partners and contractors is compliant with EU and USA GMP legislation, guidelines and/or Pharming quality expectations. He or she evaluates, analyzes and prepares pharmaceutical related documents needed for batch release and compliance to GMP. Areas of responsibilities: Write, implement, review and maintain SOPs, policies and other QA related documentation. in alignment with applicable GxP guidelines. Identify documents which need to be created or updated and ensure this is organized. Act as co-trainer and expert for other Quality Assurance Officers. Organize meetings with BME and/or Pharming departments to ensure problem resolution and conducting investigations associated with deviations, Change Controls, and CAPA’s. Review, analyze and prepare documentation related to commercial starting material production, including batch records, specifications and certificates to ensure compliance with applicable guidelines and procedures. Identify and communicate areas for improvement. Propose ideas for site improvements. Preparing and supporting internal and external audits in relation to applicable guidelines (like GMP, GLP, ISO, GDP, GCP). Required skills & qualifications in order to be successful in this role: Decisiveness Communicative Responsible Quality oriented Teamwork Problem analysis Behavioral flexibility Knowledge: Education: BSc. Biotechnology, chemistry, biopharmaceutics or equivalent Technical skills: Extensive knowledge of and experience with GMP regulations for EU and US. (like GMP, GLP, ISO, GDP, GCP) Experience: Four years of experience in (bio)pharmaceutical environment with at least one year in Quality Assurance.
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 PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Recruitment Talent Acquisition Specialist Full-time Leiden Human Resources HR Coordinator Full-time Warren, New Jersey USA ICT Servicedesk Engineer Full-time Leiden Bijgekomen; Afgenomen: Financial Accountant Full-time Leiden Aantal openstaand: 21 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 45 Vervuld: 36
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 DSP Specialist Full-time Oss PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Recruitment Talent Acquisition Specialist Full-time Leiden Human Resources HR Coordinator Full-time Warren, New Jersey USA ICT Servicedesk Engineer Full-time Leiden Bijgekomen; DSP Specialist Full-time Oss Afgenomen: Aantal openstaand: 22 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 46 Vervuld: 36
DSP Specialist Full-time Oss 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 DSP Specialist About the role: The DSP Specialist will provide front line (technical) support for the process equipment and manufacturing process during the initial startup and in future day to day operations. Within GMP guidelines, the DSP Specialist ensures successful manufacturing production runs, by assessing risks, validating process and equipment, implementing preventative measurements, investigating, and troubleshooting processes and process equipment. Areas of responsibilities: Writes and/ or revises SOP’s, batch records, WI’s and other operational related documents. Conducts technical training and guidance to production personnel. Involved in the execution of process qualification and validation activities To trend key performance metrics in order to avoid and/or solve process issues (continuous process verification). Collaborates with technical, process and operational stakeholders in order to avoid and/or solve process issues. Issues and implements CAPA/ CCR and deviations Represents Manufacturing operations in Change Control, CAPA end deviations meetings to gather relevant information in regard to issues and implement CAPA/ CCR and deviations Acts as SME in internal audit/ inspections. Leads projects within DSP. Participates and/or represents department in medium complex projects. Required skills and qualifications in order to be successful in this role: Collaboration Personal Agility Analytic Ability Problem solving Decisiveness Knowledge: Bachelor’ or Master's degree e.g. (Chemical) Engineering, Pharmacy, Biochemistry, Life Science & Technology, Biology Good technical knowledge of cGMP Compliance Excellent knowledge of Downstream processing (e.g. chromatography/ purification and other separation technologies) and equipment Knowledge of electronic quality systems and ERP systems is an advantage. Excellent verbal and (technical) writing skills both in English and Dutch Experience: Minimal 7 years of DSP experience A minimum of 6 years of cGMP production experience in a Downstream Processing facility Involvement in process validation activities Experience with lean manufacturing principles (Green Belt certified is an advantage)
Janssen&Janssen schreef op 3 mei 2021 14:01 :
Vervuld: 36
Ik zie dat jij beweert dat 36 vacatures vervuld zijn. Heb je daarvan een bron? Vacatures kunnen ook geannuleerd worden namelijk.
Tuurlijk een vacature wordt voor de lol geplaatst...... om de niet wetende belegger te doen geloven dat het heel erg goed gaat met je bedrijf.... LOL.
De Monitor - Pharming Professor schreef op 3 mei 2021 14:23 :
[...]
Ik zie dat jij beweert dat 36 vacatures vervuld zijn.
Heb je daarvan een bron? Vacatures kunnen ook geannuleerd worden namelijk.
Heb jij een bron dat ze geannuleerd zijn? lijkt me geen reden voor de annulering of dat Pharming informatie deelt erover.
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 Downstream Processing Specialist Full-time Oss 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 PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Recruitment Talent Acquisition Specialist Full-time Leiden Human Resources HR Coordinator Full-time Warren, New Jersey USA ICT Servicedesk Engineer Full-time Leiden Bijgekomen; DSP Specialist Full-time Oss Rectificatie Pharming heeft deze zelf onder production opnieuw ingedeeld ipv Technical Operations met een nieuwe naam Downstream Processing Specialist Full-time Oss Afgenomen: Aantal openstaand: 22 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 46 Vervuld: 36
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 PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer Full-time Leiden Regulatory Affairs Specialist Full -time Leiden Recruitment Talent Acquisition Specialist 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; Regulatory Affairs Specialist Full -time Leiden Functional Application Manager Full-time Leiden Sr. Servicedesk Engineer Full-time Warren, New Jersey USA Afgenomen: HR Coordinator Full-time Warren, New Jersey USA Aantal openstaand: 24 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 49 Vervuld: 37
Regulatory Affairs Specialist 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 Regulatory Affairs Specialist for our HQ in Leiden. About the role: The Regulatory Affairs (RA) Senior Specialist, in close collaboration with the Director RA, will be responsible for the creation (writing and/or compilation) of documents and adherence to appropriate legislation and regulations pertaining to the biomedical regulatory part of the medicinal product dossier. The RA Biomedical Senior Specialist is aware of the Competent Authority expectations and can pro-actively and independently convey these expectations within the organization. Areas of responsibilities: Investigate and analyze requirements for regulatory procedures based on legislation and regulations and ensure appropriate documents are in place. Coordinate with the relevant Pharming departments (e.g. Pharmacovigilance, Medical, Clinical, Marketing & Sales, and Supply Chain) according to the purpose of the procedure, based on the requirements of the (regional) Competent Authorities Dependent on content expertise, write and/or review, guide, compile, and submit documents (CTAs, PSURs, DSURs, PIP, labelling, Policy 0043/0070 documents, protocols, educational materials, artwork mock-ups, promotional materials) for different regulatory procedures Guide, coach, teach and/or instruct other Pharming departments on how regulatory requirements can be met Evaluate compliance of advertising and / or medical information material with (inter)national legislation Compile, finalize and distribute internally and/or externally regulatory documents such as product information (Module 1.3.1 - 1.3.2), CPPs, etc. Maintain overviews, archive documents, follow procedures, perform life cycle management activities (e.g. in eDMS) Ensure that eCTD files are brought and maintained up-to-date Collect/compose required documents, set-up meetings with relevant stakeholders, create reports/minutes of meetings Develop regulatory strategies for procedures, take initiatives and gain support for this in the relevant Pharming departments Participate in project teams. Provide support in biomedical fields of RA to project teams Act as contact person for regulatory authorities and provide internal and external communication regarding registration requests Be the contact person for (inter)national partners/sites (such as eCTD publisher, pharmacovigilance provider(s), regulatory consultants, translation agencies, artwork agency/manufacturers) Act as the internal RA representative in project teams Act as the RA lead in assigned project teams Required skills and qualifications in order to be successful in this role: Independent worker Accuracy & attention to detail Excellent writing skills (ability to process complex scientific/medical information) A structured approach, able to plan and organize, and set priorities The ability to work independently and be proactive Collaborative and good communication skills; enjoy working in a multidisciplinary team Results-oriented Stress resistant, resilient, and flexible Knowledge: A university degree (MSc.) in a relevant discipline such as Pharmacy, Pharmacology, (Medical) Biology, (Biomedical) Pharmaceutical Science Experience with MS-Word, MS-Outlook, MS-Excel Knowledge of regulatory procedures and EU guidelines for the content of regulatory dossiers, product information, pharmacovigilance, and drug advertising Good command of the Dutch and English language in word and writing Experience: At least 4 years of experience in Regulatory Affairs Relevant experience with regulatory procedures and compilation and/or writing of dossier module texts Experience with eDMS Experience with eCTD life-cycle management
Functional Application 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 Functional Application Manager. About the role: The functional application manager advises and supports the business on ICT application requirements and collaborates with them to ensure best fit of application and optimal use by the organization. He/she is responsible for the life cycle management of a set of allocated applications, from operational functionality to maintenance, version control and upgrades of these applications. Areas of responsibilities: Partners with managers on ICT requirements in order to optimize existing and new application functions Provides guidance to managers to define their requirements and translates these needs into new and/or improved solutions Together with external partners develop and maintain the applications assigned to you to ensure availability, reliability and continuity Collaborate with the ICT team/IT Infrastructure Specialist to maintain company infrastructure standards Initiates, formulates and implements new features, processes and procedures within own functional area. Provides trainings to employees both written manuals as classroom to ensure the optimal level of knowledge of users Manage and implement changes and new releases Required skills and qualifications in order to be successful in this role: Organizational Sensitivity with a strong customer focus Planning and organizing Excellent communication skills in English and Dutch Problem analysis skills Agile Result oriented Knowledge: HBO ICT SAP knowledge & experience Database knowledge Power B.I. Exact online knowledge LIMS basic knowledge Experience: Minimum of 4 years experience in a similar role
Sr. Servicedesk Engineer 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 Sr. Servicedesk Engineer About the role: The Sr. Servicedesk Engineer provides outstanding customer support for the Pharming N.V. and the US Pharming Healthcare Inc. business by responding to employee inquiries from start to finish and resolving or escalating issues relating to hardware, software and network to ensure that the most important problems are resolved promptly. The Sr. Servicedesk Engineer will provide training and set-up for new hires, manage the maintenance inventory of equipment, and provide support for system enhancements, integrations, and technology needs. Areas of responsibilities: Install, upgrade, support and resolve issues related to PC’s or laptops, printers, scanners, phones. LAN and WAN, hardware and software Project support for IT as well as the US Business (e.g. data collection/hardware installation, system upgrades, M&A) Support new system implementations and integrations and the identification and adoption of new technologies. Ensure all systems are managed and tracked in the asset management system. Ensure IT Operations complies with all the IT defined policies and procedures. Diagnose hardware, software, and operator problems and take appropriate remedial actions and document installation and configuration procedures. Testing and evaluating new hardware or software applications as upgrades or enhancements to the production environment. Improve customer services, helping in developing competent servicedesk and tools, procedures. Communicate with vendors that resolve issues related to software, hardware and network. Continually interact with ICT team and document issues and resolutions addressed in Service Desk Knowledgebase. Handle and control issues throughout their lifecycle, beginning from first point of contact until it is resolved. During this process, keep users updated on the progress. Provide support to disaster recovery solutions and record incidents correctly and categorize and prioritize them. Monitor SLA and ensure there are no breaches. Suggest ideas for improving service desk functions and service delivery Maintain security, anti-virus solutions, configure and maintain operating systems and software applications, backup devices. Required skills and qualifications in order to be successful in this role: Organizational Sensitivity with a strong customer focus Planning and organizing Excellent communication skills Problem analysis skills Agile Teamwork Eager to learn Knowledge: Degree in ICT / A+ Certification or equivalent ITIL certification preferred OS certification preferred CSE certification preferred Experience: Minimum of 4 years experience experience troubleshooting network and PC hardware and software in a mixed Windows network environment. Office 365 Windows 10 Azure Microsoft 365 TOPdesk
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 PMO Project Manager Full-time Leiden Regulatory Affairs Medical Writer 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 Bijgekomen; Corporate Recruiter Full-time Leiden Afgenomen: Regulatory Affairs Specialist Full -time Leiden Talent Acquisition Specialist Full-time Leiden Aantal openstaand: 23 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 50 Vervuld: 39
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 Corporate Recruiter for the Talent Acquisition department in our Leiden office. About the role: As Corporate Recruiter, you will be responsible for attracting and hiring talent for Pharming vacancies, ensuring that Pharming’s mission, vision and culture is incorporated in the recruitment process. The 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: Effective and timely sourcing of candidates for Pharming vacancies Strategic use of LinkedIn and other candidate sourcing channels Provide an excellent candidate experience that incorporates Pharming’s culture and values Participate in Employer Branding projects Partner with hiring managers to ensure an efficient and smooth talent acquisition process Monitor metrics to help optimize the recruitment process Monitoring of a large volume of vacancies and tight timelines Coordinate and plan talent acquisition activities Advise hiring manager in selection process 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: 3-5 years work experience in a similar position Fluent in both Dutch and English 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 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; Regulatory Affairs (Senior) Specialist CMC Full-time Leiden Director Procurement Full-time Leiden Afgenomen: Aantal openstaand: 25 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 52 Vervuld: 39
Regulatory Affairs (Senior) Specialist CMC 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 Regulatory Affairs (Senior) Specialist CMC for our HQ in Leiden. About the role: The Regulatory Affairs (RA) (senior) specialist Chemical Manufacturing and Control (CMC) will, review, edit, write and/or compile technical documents for regulatory submissions in order to obtain swift regulatory approvals first time right. Regulatory submissions include documents that originate from different departments and/or functional areas. Investigation of the regulatory requirements and compilation of the submissions require good cross-departmental communication skills, curiosity & eagerness, open-mindedness, confidence, and no hesitation to ask questions. Areas of responsibilities: Review, edit, or write CMC documents (e.g. protocols, study reports, technical documents, IMPDs, annual reports, Module 2 QOS & Module 3 sections, briefing books) and ensure these are submission-ready both from a content and document-technical perspective Compile/collect the CMC documents needed for submission packages to Competent Authorities Act as a contact person for regulatory authorities and provide internal and external communication regarding regulatory requests Act as an internal RA representative in (CMC) project teams, set up meetings with relevant stakeholders, create meeting reports/minutes and guard the assigned timeframe Act as contact person for (inter)national partners/sites Review and provide input regarding Change Control requests Investigate and analyze requirements for regulatory documents and procedures based on the appropriate regulatory guidance Maintain overviews, archive documents, perform life cycle management activities (e.g. in eDMS) Ensure that eCTD files are brought and maintained up to date Work on/with IT-systems to track regulatory submissions in each region Roll out and implement variation packages to ROW countries in compliance with local regulatory requirements Perform the QC on DRAFT eCTD submission packages before submission Required skills and qualifications in order to be successful in this role: Independent worker Accuracy & attention to detail A structured approach, able to plan and organize, and set priorities The ability to work independently and be proactive Curious and eager to learn Collaborative and good communication skills; enjoy working in a multidisciplinary team Stress resistant, resilient, and flexible Knowledge: A university degree (MSc.) in a relevant discipline such as Pharmacy, Pharmacology, (Medical) Biology, (Biomedical) Pharmaceutical Science Preferably knowledge of regulatory procedures and guidelines for the CMC content of regulatory dossiers Good command of the Dutch and English language in word and writing Experience: At least 1-2 years of experience in Regulatory Affairs Relevant experience with regulatory procedures and compilation and/or writing of dossier module texts Experience with MS-Word, MS-Outlook, MS-Excel Preferably knowledge of and experience with electronic document management systems (eDMS) and eCTD granularity & life-cycle management
Director Procurement 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 Director Procurement for our HQ in Leiden. About the role: The Procurement Director will support the business in the sourcing and procurement process. You will help develop and implement a best-practice procurement strategy and build the new department within Pharming. In this role you will analyze organizational spend, determine business procurement needs, assess market conditions, set clear objectives and KPIs, define procurement policies and develop the procurement strategy. You will lead the negotiations on key business contracts. The Procurement Director will also be the SAP Business Process Owner during the SAP implementation that is currently ongoing. In that role, you will shape the Purchase to Pay process as well as contract management and supplier management. As such you will have a pivotal role in change management for these areas across the Pharming business. Areas of responsibilities: Develop and implement the Procurement strategy, policy and procedures, to ensure that we specify, select and contract our procurement needs Create willingness in the organization to actively support the procurement policies and procedures, by showing the added value to the organization Lead negotiations on key business contracts, ensuring efficient buying in line with business needs Analyze procurement data to support decision making, ensuring partnerships with the correct suppliers Set procurement objectives and KPIs for business needs Lead (is Business Process Owner) in SAP implementation and after SAP go-live on Purchase to Pay process as well as contract management and supplier management Set priorities by analyzing spend data from multiple sources with analytics tools such as PowerBI, Microsoft Excel Serve as the primary contact for procurement related questions, training, policy and procedure interpretation and alignment by all departments Required skills and qualifications in order to be successful in this role: Initiative Networking skills Strong focus on results Strong negotiation skills Analytical thinker with excellent problem analysis/solving skills Organizational sensitivity Knowledge: MSc. degree with a focus on Procurement, Supply Chain Management, Operations Management, Mathematics/Engineering or MBA Nevi-2 or comparable qualification SAP working knowledge Sound knowledge of sourcing/procurement strategies Knowledge of Contractual terms including IP, data protection regulation Strong communication and presentation skills Fluent in English and Dutch language Experience: At least 6 years of Procurement experience (contracting/negotiations) Experience in the pharmaceutical industry is preferred
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; Medical Affairs Regional Medical Director DACH Full-time DACH Regional Medical Director UK Full-time UK Afgenomen: Aantal openstaand: 27 Totaal vacatures toe of afname vanaf 29 sept 2020 Bijgekomen: 54 Vervuld: 39
Regional Medical Director DACH Full-time · DACH 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 DACH 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)
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Almunda Professionals (vh Novisource)
Alpha Pro Tech
Alphabet Inc.
Altice
Alumexx ((Voorheen Phelix (voorheen Inverko))
AM
Amarin Corporation
Amerikaanse aandelen
AMG
AMS
Amsterdam Commodities
AMT Holding
Anavex Life Sciences Corp
Antonov
Aperam
Apollo Alternative Assets
Apple
Arcadis
Arcelor Mittal
Archos
Arcona Property Fund
arGEN-X
Aroundtown SA
Arrowhead Research
Ascencio
ASIT biotech
ASMI
ASML
ASR Nederland
ATAI Life Sciences
Atenor Group
Athlon Group
Atrium European Real Estate
Auplata
Avantium
Axsome Therapeutics
Azelis Group
Azerion
B&S Group
Baan
Ballast Nedam
BALTA GROUP N.V.
BAM Groep
Banco de Sabadell
Banimmo A
Barco
Barrick Gold
BASF SE
Basic-Fit
Basilix
Batenburg Beheer
BE Semiconductor
Beaulieulaan
Befimmo
Bekaert
Belgische aandelen
Beluga
Beter Bed
Bever
Binck
Biocartis
Biophytis
Biosynex
Biotalys
Bitcoin en andere cryptocurrencies
bluebird bio
Blydenstijn-Willink
BMW
BNP Paribas S.A.
Boeing Company
Bols (Lucas Bols N.V.)
Bone Therapeutics
Borr Drilling
Boskalis
BP PLC
bpost
Brand Funding
Brederode
Brill
Bristol-Myers Squibb
Brunel
C/Tac
Campine
Canadese aandelen
Care Property Invest
Carmila
Carrefour
Cate, ten
CECONOMY
Celyad
CFD's
CFE
CGG
Chinese aandelen
Cibox Interactive
Citygroup
Claranova
CM.com
Co.Br.Ha.
Coca-Cola European Partners
Cofinimmo
Cognosec
Colruyt
Commerzbank
Compagnie des Alpes
Compagnie du Bois Sauvage
Connect Group
Continental AG
Corbion
Core Labs
Corporate Express
Corus
Crescent (voorheen Option)
Crown van Gelder
Crucell
CTP
Curetis
CV-meter
CVC Capital Partners
Cyber Security 1 AB
Cybergun
D'Ieteren
D.E Master Blenders 1753
Deceuninck
Delta Lloyd
DEME
Deutsche Cannabis
DEUTSCHE POST AG
Dexia
DGB Group
DIA
Diegem Kennedy
Distri-Land Certificate
DNC
Dockwise
DPA Flex Group
Draka Holding
DSC2
DSM
Duitse aandelen
Dutch Star Companies ONE
Duurzaam Beleggen
DVRG
Ease2pay
Ebusco
Eckert-Ziegler
Econocom Group
Econosto
Edelmetalen
Ekopak
Elastic N.V.
Elia
Endemol
Energie
Energiekontor
Engie
Envipco
Erasmus Beursspel
Eriks
Esperite (voorheen Cryo Save)
EUR/USD
Eurobio
Eurocastle
Eurocommercial Properties
Euronav
Euronext
Euronext
Euronext.liffe Optiecompetitie
Europcar Mobility Group
Europlasma
EVC
EVS Broadcast Equipment
Exact
Exmar
Exor
Facebook
Fagron
Fastned
Fingerprint Cards AB
First Solar Inc
FlatexDeGiro
Floridienne
Flow Traders
Fluxys Belgium D
FNG (voorheen DICO International)
Fondsmanager Gezocht
ForFarmers
Fountain
Frans Maas
Franse aandelen
FuelCell Energy
Fugro
Futures
FX, Forex, foreign exchange market, valutamarkt
Galapagos
Gamma
Gaussin
GBL
Gemalto
General Electric
Genfit
Genmab
GeoJunxion
Getronics
Gilead Sciences
Gimv
Global Graphics
Goud
GrandVision
Great Panther Mining
Greenyard
Grolsch
Grondstoffen
Grontmij
Guru
Hagemeyer
HAL
Hamon Groep
Hedge funds: Haaien of helden?
Heijmans
Heineken
Hello Fresh
HES Beheer
Hitt
Holland Colours
Homburg Invest
Home Invest Belgium
Hoop Effektenbank, v.d.
Hunter Douglas
Hydratec Industries (v/h Nyloplast)
HyGear (NPEX effectenbeurs)
HYLORIS
Hypotheken
IBA
ICT Automatisering
Iep Invest (voorheen Punch International)
Ierse aandelen
IEX Group
IEX.nl Sparen
IMCD
Immo Moury
Immobel
Imtech
ING Groep
Innoconcepts
InPost
Insmed Incorporated (INSM)
IntegraGen
Intel
Intertrust
Intervest Offices & Warehouses
Intrasense
InVivo Therapeutics Holdings Corp (NVIV)
Isotis
JDE PEET'S
Jensen-Group
Jetix Europe
Johnson & Johnson
Just Eat Takeaway
Kardan
Kas Bank
KBC Ancora
KBC Groep
Kendrion
Keyware Technologies
Kiadis Pharma
Kinepolis Group
KKO International
Klépierre
KPN
KPNQwest
KUKA AG
La Jolla Pharmaceutical
Lavide Holding (voorheen Qurius)
LBC
LBI International
Leasinvest
Logica
Lotus Bakeries
Macintosh Retail Group
Majorel
Marel
Mastrad
Materialise NV
McGregor
MDxHealth
Mediq
Melexis
Merus Labs International
Merus NV
Microsoft
Miko
Mithra Pharmaceuticals
Montea
Moolen, van der
Mopoli
Morefield Group
Mota-Engil Africa
MotorK
Moury Construct
MTY Holdings (voorheen Alanheri)
Nationale Bank van België
Nationale Nederlanden
NBZ
Nedap
Nedfield
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Nel ASA
Neoen SA
Neopost
Neovacs
NEPI Rockcastle
Netflix
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NewTree
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NIBC
Nieuwe Steen Investments
Nintendo
Nokia
Nokia OYJ
Nokia Oyj
Novacyt
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NPEX
NR21
Numico
Nutreco
Nvidia
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Nyrstar
Nyxoah
Océ
OCI
Octoplus
Oil States International
Onconova Therapeutics
Ontex
Onward Medical
Onxeo SA
OpenTV
OpGen
Opinies - Tilburg Trading Club
Opportunty Investment Management
Orange Belgium
Oranjewoud
Ordina Beheer
Oud ForFarmers
Oxurion (vh ThromboGenics)
P&O Nedlloyd
PAVmed
Payton Planar Magnetics
Perpetuals, Steepeners
Pershing Square Holdings Ltd
Personalized Nursing Services
Pfizer
Pharco
Pharming
Pharnext
Philips
Picanol
Pieris Pharmaceuticals
Plug Power
Politiek
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PostNL
Priority Telecom
Prologis Euro Prop
ProQR Therapeutics
PROSIEBENSAT.1 MEDIA SE
Prosus
Proximus
Qrf
Qualcomm
Quest For Growth
Rabobank Certificaat
Randstad
Range Beleggen
Recticel
Reed Elsevier
Reesink
Refresco Gerber
Reibel
Relief therapeutics
Renewi
Rente en valuta
Resilux
Retail Estates
RoodMicrotec
Roularta Media
Royal Bank Of Scotland
Royal Dutch Shell
RTL Group
RTL Group
S&P 500
Samas Groep
Sapec
SBM Offshore
Scandinavische (Noorse, Zweedse, Deense, Finse) aandelen
Schuitema
Seagull
Sequana Medical
Shurgard
Siemens Gamesa
Sif Holding
Signify
Simac
Sioen Industries
Sipef
Sligro Food Group
SMA Solar technology
Smartphoto Group
Smit Internationale
Snowworld
SNS Fundcoach Beleggingsfondsen Competitie
SNS Reaal
SNS Small & Midcap Competitie
Sofina
Softimat
Solocal Group
Solvac
Solvay
Sopheon
Spadel
Sparen voor later
Spectra7 Microsystems
Spotify
Spyker N.V.
Stellantis
Stellantis
Stern
Stork
Sucraf A en B
Sunrun
Super de Boer
SVK (Scheerders van Kerchove)
Syensqo
Systeem Trading
Taiwan Semiconductor Manufacturing Company (TSMC)
Technicolor
Tele Atlas
Telegraaf Media
Telenet Groep Holding
Tencent Holdings Ltd
Tesla Motors Inc.
Tessenderlo Group
Tetragon Financial Group
Teva Pharmaceutical Industries
Texaf
Theon International
TherapeuticsMD
Thunderbird Resorts
TIE
Tigenix
Tikkurila
TINC
TITAN CEMENT INTERNATIONAL
TKH Group
TMC
TNT Express
TomTom
Transocean
Trigano
Tubize
Turbo's
Twilio
UCB
Umicore
Unibail-Rodamco
Unifiedpost
Unilever
Unilever
uniQure
Unit 4 Agresso
Univar
Universal Music Group
USG People
Vallourec
Value8
Value8 Cum Pref
Van de Velde
Van Lanschot
Vastned
Vastned Retail Belgium
Vedior
VendexKBB
VEON
Vermogensbeheer
Versatel
VESTAS WIND SYSTEMS
VGP
Via Net.Works
Viohalco
Vivendi
Vivoryon Therapeutics
VNU
VolkerWessels
Volkswagen
Volta Finance
Vonovia
Vopak
Warehouses
Wave Life Sciences Ltd
Wavin
WDP
Wegener
Weibo Corp
Wereldhave
Wereldhave Belgium
Wessanen
What's Cooking
Wolters Kluwer
X-FAB
Xebec
Xeikon
Xior
Yatra Capital Limited
Zalando
Zenitel
Zénobe Gramme
Ziggo
Zilver - Silver World Spot (USD)