Beleidsmedewerker
Randstad
Hoofddorp, NHHet komende jaar kun jij een leuke baan in je bezit hebben! Doe je het goed, zeker wel langer!
Stichting Lira, die eerlijke vergoedingen voor tekstmakers uitbetaald, is op zoek naar een beleidsmedewerker voor 32-38 uur in week.
- uitzicht op vaste baan
- salaris o.b.v. ervaring
- flexibele werktijden
- uitdagende en afwisselende baan
- informele en collegiale bedrijfscultuur
- werken vanuit huis
Heb jij een bedrijfskundige en/of juridische achtergrond op minstens HBO niveau?Heb je minimaal 3 jaar relevante (beleidsondersteunende) werkervaring? Dan zijn wij op zoek naar jou!
- HBO opleiding met juridische en/of bedrijfskundige achtergrond
- minstens 3 jaar ervaring in een (politieke) functie waarin gecompliceerde administratieve processen een belangrijke rol spelen
- ervaring met voorbereiden en schrijven van beleidsnotities
- ervaring met projectmatig werken en/of het begeleiden van een project.
- je bent analytisch en hebt cijfermatig inzicht
Je komt te werken in een politieke omgeving. In het sterk veranderende digitale landschap vinden steeds meer vormen van exploitatie van auteursrechtelijk beschermd werk plaats.
Jij komt in deze functie op voor een rechtvaardige vergoeding voor tekstmakers.
Achter de schermen zal jij onderdeel uitmaken van de processen om dit allemaal rond te krijgen. Als spil in het web zorg jij dat er overzicht is. Communiceer je duidelijk met alle betrokken partijen en kijk je kritisch naar de processen en hoe die verbetert kunnen worden.
- het beleidsmatig optimaliseren van incassomogelijkheden, in binnen- en buitenland, en de verdeling van de geïncasseerde gelden aan tekstmakers.
- Het onderhandelen met gebruikers en licentiehouders van auteursrechtelijk beschermde werken.
- Het analyseren van de uitgevoerde uitkeringen.
- Het afstemmen van de werkzaamheden met backoffice en ondersteunende stafafdelingen
- het begeleiden en coördineren van onderzoeken naar gebruik van auteursrechtelijk beschermd materiaal.
- algemene (beleids-) initiërende en ondersteunende werkzaamheden.
- communicatie verbeteren en optimaliseren van externe communicatie, waaronder de website, de webportal en social media.
- behandelen van vragen van relaties.
Cedar is de serviceorganisatie van 7 auterusrecht-stichtingen. Jij zal komen te werken voor de Stichting Lira. Het team bestaat uit de directeur en adjunct directeur en een collega-beleidsmedewerker. Het is een klein team met veel toewijding aan het werk.
- nauwe samenwerking in een klein team.
- collegiaal en informele bedrijfscultuur.
Bezit jij over bovengenoemde ervaring en kennis? Solliciteer dan direct en dan nemen wij z.s.m. contact met je op!
Toch nog vragen? Stel ze gerust en stuur mij een mailtje of bel mij op.
Vacaturenummer: 456757
BI Officer
Michael Page International Netherlands SA
Amstelveen, NH
The Business Intelligence Officer collaborates with cross-functional teams (marketing, business development, sales retail & institution, finance, Supply Chain, HR) as a leader of quantitative analysis. The Business Intelligence Officer will deliver dashboards & qualitative data analysis to the general management to help drive business insights and operational plans.
Client Details
Mylan is now part of Viatris, a new global healthcare company committed to empowering people to live healthier at every stage of life. Our policy vision for a healthy future focuses on achieving better health in the communities we serve through building on our unique capabilities to advance health solutions and working with key stakeholders.
Description
Responsibility N°1: Planning, coordinating, and designing BI activities.
* Activity 1.1 Planning and implementation of BI projects, outlining project stages and assessing business implications for each stage.
* Activity 1.2 Monitoring progress and producing status reports to assure project deadlines, standards, and cost targets are met.
* Activity 1.3 Create and support a culture of decision-making based of analytic insights by defining KPIs together with the stakeholders, identifying competitive toolsets and implementing best practices.
Responsibility N°2: Working closely with decision makers in other departments to identify, recommend, develop, implement, and support cost-effective reporting solutions for all aspects of the organization. Collaborating with internal and external stakeholders to define business and systems requirements in delivering new reporting functionalities.
* Activity 2.1 Producing analyses to inform strategic planning, market/competitor assessments, identification of, market projections, demographics, market share, market opportunities, physician demand by specialty and business development planning.
* Activity 2.2 Guiding the work to develop improved reporting and tracking of metrics against key business goals and KPI's (Sales, Marketing & Supply Chain)
* Activity 2.3 Fielding strategic questions from varied end users (management team) and translating those requests into actionable data requests and written findings Manage forecasts across the business and effectively communicate performance and variance to guide business decisions and actions at a senior level.
Responsibility N°3: Defining and implementing IT solutions, procedures and best practices for the BI environment.
* Activity 3.1 Manage the deployment, monitoring, maintenance, development, upgrade, and support of BI systems/tools.
* Activity 3.2 Benchmark, analyze, report on, and make recommendations for the improvement and growth of the IT infrastructure that supports the BI environment.
Profile
QUALIFICATIONS / KNOWLEDGE
▪ University degree, preferably in Marketing, Business Administration or Economics
▪ Minimum of 3 years of experience within in a Pharmaceutical Environment, with at least 2 years in a similar role
▪ Advanced Project management & Business Analytical skills
▪ Experience in an international environment is an asset
▪ Fluent in English and Dutch, in speaking, reading, writing and presenting.
COMPETENCIES
▪ Advanced ability to analyze and translate business needs into BI dashboards & recommendations
▪ Comfort around higher management (from middle management to c-level)
▪ Cross-functional coordination against a common goal
▪ Ability to achieve results through cross-functional teams
▪ Experienced level of Excel, Access and other data-management tools.
BEHAVIOURS Values & Leadership Expectations Integrity
▪ Influencing colleagues with Enthusiasm, Ideas and Behaviors
▪ Treating People with Integrity, Service and Respect
▪ Gaining colleagues' trust by consistently being open and honest
Service
▪ Demonstrating curiosity and willingness to learn from each other
▪ Listening to others with an open mind and accepting feedback for growth
▪ Sharing knowledge and coach each other towards success
Innovation
▪ Challenging the status quo and offering alternatives
▪ Promoting an environment where everyone can do their best work
▪ Taking new approaches to achieve breakthrough despite uncertainty
Reliability
▪ Setting high standards of performance for ourselves
▪ Owning the plans, processes and outcomes related to our roles & responsibilities
▪ Demonstrating Reliability by delivering on commitments
Teamwork
▪ Achieving ideal outcomes by teamwork & collaboration
▪ Treating Team members with consideration and working constructively to resolve differences
▪ Ensuring the right people are at the table when decisions are made
Job Offer
Working within a growing and diverse company, within a data driven environment.
Excellent remuneration package + benefits
Information Security Officer
Michael Page International Netherlands SA
Amsterdam, NH
The Information Security Officer handles the information security and data protection standards / measures in the bank. You act as as a sparring partner and well trusted counsel. You have up to date knowledge of- and experience in privacy, information security and data protection laws/regulations/trends related to MBE's activities and the financial industry.
Client Details
Mizuho Bank (MBE) is one of the leading global financial companies. The Legal & Compliance department is responsible for effective and efficient management of legal, compliance and regulatory advisory services and ensuring effective management management of regulatory, legal, compliance and contractual risks. Additionally, the Legal & Compliance department is responsible for the Bank's Information Security Framework and Data Protection. Further, the department organizes the SB and ARC and NPC meetings on annual basis as well as the permanent education of their MB and SB. The Legal & Compliance department services the whole bank, including its foreign offices.
Description
The Information Security Officer challenges the Director Legal & Compliance in handling the information security and data protection matters in the bank and strives for best feasible information security & data protection standards/measures in the bank. You act as as a sparring partner and well trusted counsel. You have up to date knowledge of- and experience in privacy, information security and data protection laws/regulations/trends related to MBE's activities and the financial industry. You challenge the Director Legal&Compliance in pro-actively advising and assisting on privacy, information security and data protection issues. Coordinate assessing and treating information security and data protection risks of the Bank. Handling internal and external inquiries/complaints on the usage of personal data. You maintain effective MBE privacy, information security and data protection related policies, procedures and documentation, and if the update/review of these are in line with good standards and recent developments. You support the business and assist the Director Legal&Compliance in (ad hoc) projects/subcommittees and other privacy, information security and data protection matters. Collect, monitor and analyze laws/regulations/regulatory trends related to MBE's activities and inform relevant staff/BCT/ take appropriate actions. Maintain and advising on privacy, information security and data protection standards of MBE and conduct training to security awareness. You monitor and facilitate secure and compliant behaviour of all staff and gather, maintain and supervise the use of personal data and the related tools/inventory. Review, draft and advise on privacy, information security and data protection documentation and pro-actively establish new frameworks/templates if necessary. Establish and maintain regular meetings with privacy, information security and data protection related staff of MHBK Ltd London on the outsourced activities and HO on these topics as well as with MBE IT department. All with the aim to advise on the technology and security aspects of personal date processing. You assist the Director Legal&Compliance in solicited and unsolicited privacy, information security and data protection advice to staff/stakeholders and responding to consultations from staff regarding this and give advice and make recommendations.
Profile
- Bachelor / Master degree, preferably in Information Security / Technology or other relevant fields
- At least 5 years of experience in a similar role as Information Security Officer, preferably in the financial sector
- Preferably certified as CISSP / CISM / CISA
- Fluent in English, bot verbally as in writing
- Strong knowledge in privacy, information security and data protection law (NL and EU) in financial industry.
Job Offer
Very good and competitive remuneration package, great secondary benefits, 37,5 hours working week, training and development possibilities.
HR Assistant
Page Personnel
Amsterdam, NH
Are you passionate in HR administration? Are you looking for a new challenge in a fast-paced and international company?
Keep looking on this vacancy! Maybe it can be your opportunity!
Client Details
The client is one of the largest Service Center within the airline industry. In the HR division they execute staff related policies, processes and safeguard staff administration and management information.
As HR Assistant you safeguard and execute the HR administrative processes, in line with the HR policy
and the administrative requirements of the company. You will provide correct and up-to-date staff
information, and to ensure that agreed labour conditions can be effected. You also secure the day-to-day
functional application activities and payroll activities if needed.
Description
* Support Manager HR Operations, HR Officers and HR Consultant by informing staff and
executing all necessary administrative activities to ensure that agreed labour conditions will be
effected.
* Register all relevant staff information in the personnel information system. Advising employees
and management on operational HR matters and labour conditions.
* Signal and take action upon malfunctions in processes and procedures and propose
improvements.
* Create and distribute standard and ad hoc management information to the proper departments
and/or requestor.
* Secure functional application activities and process/system improvements (act as a backup for
the functional application manager).
Profile
3-5 year work experience in an HR administration position
* Knowledge of administrative tasks and responsibilities.
* Affinity with personnel information systems.(AFAS/Profit)
* Native Dutch and good knowledge of English (written and spoken).
* Experience with Microsoft office such as Word and Outlook. Good knowledge of Excel is a must.
* Outstanding interpersonal skills.
* You are available at least 32 hour
Job Offer
Competitive salary
Additional training
Holiday allowance, travel allowance, pension and discount on your personal health insurance.
Beleidsmedewerker IT in Europees speelveld bij De Nederlandsche Bank (DNB) - Amsterdam
Statera Recruitment
AmsterdamDe divisie Data-en Informatietechnologie bestaat uit ruim 300 fte en is bezig met een transformatie gericht op het vergroten van de slagkracht en het realiseren van de digitale transformatie. Ook wordt er hard gewerkt aan de outsourcing van een deel van de ICT-functie. Het medewerkersbestand bestaat voornamelijk uit specialisten op het gebied van IT, van MBO tot en met WO niveau en van alle leeftijden.
De vacature ontstaat binnen de afdeling CIO Office. Deze afdeling bestuurt en bewaakt de samenhang op de gebieden kwaliteit, risico’s en financiën. Daarnaast ondersteunt het CIO Office bij administratieve, secretariële en financiële processen.
Bij DNB werk je met impact op financiële stabiliteit en duurzame welvaart. Als Beleidsmedewerker IT heb jij focus op het Europese Stelsel van Centrale Banken (ESCB). Je vertegenwoordigt DNB in deze internationale overleggen. Tevens identificeer en faciliteer je op pro actieve wijze kansen voor internationale samenwerking op het gebied van innovatie.
Het werk van DNB gaat over financiële stabiliteit en duurzame welvaart. Jij hebt daar als Beleidsmedewerker IT ook impact op. Je volgt, analyseert en beoordeelt de Europese richtlijnen, projecten en ontwikkelingen op IT-gebied en je vertaalt deze naar mogelijkheden en richtlijnen voor DNB. Naast de werkzaamheden binnen het Europese speelveld ben je breder inzetbaar. Je werkt nauw samen met het Innovatielab om de innovatieve kracht van DNB uit te dragen binnen Europa.
Wat ga je precies doen?
- Je neemt namens DNB deel aan overleg in internationale gremia, zoals een werkgroep van het IT Committee (ITC) van het ESCB en stuurgroepen voor ESCB IT-projecten. Je vertegenwoordigt hierbij de DNB-belangen.
- Je coördineert de samenwerking tussen jouw collega’s in de vier ESCB ITC werkgroepen.
- Je ondersteunt het management van ICT inzake hun deelname aan internationale gremia.
- Je bouwt een netwerk op binnen DNB om als divisie DIT te kunnen adviseren en ondersteunen bij lopende en nieuwe ESCB-projecten en overige internationale samenwerkingen.
- Je houd je bezig met de beleidsvorming voor IT in het algemeen, met invloed op aangrenzende beleidsgebieden, en coördineert op afdeling overschrijdende onderwerpen en initiatieven.
- Je adviseert (schriftelijk) over written procedures en agendapunten met een IT aspect in de Governing Council en Supervisory Board.
Je beschikt over een helicopterview. Je bent initiërend en organisatiesensitief. Je bent in staat om collega’s te overtuigen, je bent resultaatgericht en beschikt over probleem analytisch vermogen.
Waar zijn we verder nog naar op zoek?
- Afgeronde academische master bijvoorbeeld in de richting van technische bedrijfskunde.
- Minimaal 5 jaar relevante werkervaring als IT beleidsmedewerker of adviseur.
- Uitstekende communicatieve vaardigheden, zowel mondeling als schriftelijk en zowel in het Nederlands als in het Engels.
- Aantoonbare affiniteit en bij voorkeur ervaring in het IT speelveld.
Een 36-urige werkweek - 32 uur kan ook - met werk midden in de financiële en economische actualiteit. Bij een heel diverse, betrouwbare en maatschappelijk betrokken werkgever in hartje Amsterdam, die voortdurend inspeelt op de veranderende eisen van onze omgeving. En die doorlopend innoveert. Dit biedt jou volop kansen je verder te verdiepen en nieuwe ervaringen op te doen. In Nederland, maar ook daarbuiten. Je start met een jaarcontract, bij goed functioneren en wanneer de (organisatorische) omstandigheden niet wijzigen is er uitzicht op voortzetting.
De overige goede arbeidsvoorwaarden die horen bij deze functie:
- Een salaris van minimaal € 3.200,-- en maximaal € 5.400,-- bruto per maand, op basis van een 36-urige werkweek. De uiteindelijke inschaling is onder meer afhankelijk van je kennis en ervaring.
- Een 13de maand en 8% vakantietoeslag berekend over 13 maanden.
- Pensioenopbouw op basis van middelloon met voorwaardelijke indexatie. Eigen bijdrage in de premie 6,25%.
- Een volledige vergoeding van je OV-reiskosten woon-werkverkeer.
- Veel mogelijkheden jezelf door opleiding en training zowel vakinhoudelijk als persoonlijk te blijven ontwikkelen.
- Een goede balans tussen je professionele en je privéleven. In deze functie is het mogelijk om 4 dagen van 8 of 9 uur te werken.
Heb je vragen of zou je een informeel contactmoment op prijs stellen om jouw carrièremogelijkheden met betrekking tot deze of andere functies te bespreken. Dit kunnen wij voor jou betekenen:
- Je kunt gebruik maken van ons uitgebreide netwerk en onze reputatie binnen de financiële sector;
- We zitten bij de opdrachtgever aan tafel, daardoor kunnen we jou optimaal voorbereiden op een succesvolle sollicitatie;
- Een sparringpartner om helder te krijgen wat jouw behoeftes en drijfveren zijn.
Charles de Jong
M: +31 (0)6 41692054
E: c.dejong@statera-recruitment.nl
Beleidsmedewerker Milieuzorg - HBO/ WO - Nucleair - vast
Arts Safety
Petten, NederlandBeleidsmedewerker Milieuzorg HBO/ WO
Functie
- Bijhouden van ontwikkelingen vanuit W&R, vanuit technologieontwikkelingen en vanuit het risico-aspect voor de bedrijfsvoering;
- Opstellen & onderhouden van het milieubeleid inclusief de risico-inventarisatie met behulp van het milieu aspecten-register;
- (Hulp bij) implementatie in de bedrijfsvoering, met name bij het vaststellen van de verantwoordelijkheden en van de diverse taken;
- Monitoring van milieuprestaties, van de uitvoering van de taken en van de review door de verantwoordelijken onder andere door interne inspecties & audits en in het kader van de Management Review en de Compliance Check;
- Rapportering naar overheden (o.a. jaarrapport);
- Functioneel leiden, organiseren en uniformeren over de units heen van de milieuzorgkolom en bewaken van interactie met aanpalende beleidsdomeinen (bv arbeidsveiligheid- en gezondheid);
- Coördinatie bij overheids-inspecties en –audits en vervullen van de functie van contactpersoon t.b.v. de overheid;
- (Mede) opstellen en coördinatie van aanvragen voor milieuvergunningen en meldingen – onderhouden van de relatie met de diverse vergunningverleners;
- Gevraagd en ongevraagd adviseren van directie en managers t.b.v. de strategische, tactische en operationele bedrijfsvoering;
- Aanjagen van de continue verbetering van de milieuprestaties.
Profiel
- Hbo- of academische opleiding in een relevante technische- of beta-richting;
- Kennis van en/of ervaring in vakgebieden zoals veiligheid, milieurecht of ruimtelijke ordening strekt tot aanbeveling;
- Minimaal 5 jaar ervaring in een milieu- of milieu-gerelateerde functie;
Team
Arbeidsvoorwaarden
Modern en marktconform arbeidsvoorwaardenpakket
- 6,3% eindejaarsuitkering en 8% vakantietoeslag;
- Pensioen bij het ABP; werkgever betaalt 74% van de premie;
- 27 vakantiedagen en 12 dagen flextijd (bij een fulltime dienstverband;
- Een goed salaris met doorgroeimogelijkheden;
- Een reiskostenvergoeding.
- Een 3-daagse onboarding voor iedereen nieuw in dienst;
- Een jaarlijks opleidingsbudget en ruimte voor je eigen wensen.
- Mogelijkheid tot verlof kopen.
- Beweging tijdens lunchtijd;
- Een actieve personeelsvereniging.
Director, Global R&D QA - Qualified Person
Incyte Corporation
Job Summary (Primary function)
The focus of this role is to provide QP certification for release of Investigational Medicinal Products (IMP) into the EU.
Job responsibilities may extend to QP certification of commercial products in EU. Qualified Person is responsible for final certification/release of pharmaceutical Products for distribution in EU.
As a member of Incyte Global Quality, QP develops and maintains a strong collaboration with external partners and Incyte cross-functional teams to support implementation of Incyte Quality Initiatives and process improvements.
Essential Functions of the Job (Key responsibilities)
• EU/EEA IMP Qualified Person responsibilities include:
• Batch release and certification of IMP to be used in EU clinical trials to ensure IMP and its manufacturers comply with the EU Directives and applicable Annexes, Product Specification File and Clinical Trial Applications
o Maintenance of Product Specification File
o Providing QP GMP declarations in support of importation of Medicinal Product into EU
o Review of IMP deviations, complaints and change controls
• Batch release and certification of commercial product for EU distribution in accordance with EU Directives and applicable Annexes
• Ensures inspection readiness for regulatory inspections including hosting audits, management of inspections/rooms and responses to regulatory agency observations
• Perform GMP/GDP audits and Mock PAIs
• Responsible for maintaining Incyte GMP Licenses and GMP/GDP activities for medicinal products in EU
• Support withdrawal of IMPs
• Negotiate QA agreements
• Represent Incyte Global QA in cross-functional project team meetings
• Collaborate with Regulatory Affairs, Clinical Operations, Global Product and Process Development (Biologics and Small Molecule) to support regulatory submissions and Incyte GMP operations
• Collaborate with external partners QA, Responsible Persons (RPs) and QPs
• Review regulatory submission documents such as INDs/IMPDs as well as Incyte’s responses to Health Authorities requests and/or questions
• Participate in develop, implementation and maintenance of Incyte's Quality Management Systems
• Develop, review and approve standard operating procedures
Qualifications (Minimal acceptable level of education, work experience, and competency)
Must be fully qualified QP with experience of final certification/release within the EU/EEA. Good knowledge of Quality management (compliance, CAPA, continuous improvement) and international operations. Knowledge of EU regulatory requirements for small molecule and biological products are essential for this role. The ideal person will have the experience and the confidence to interact with Regulatory Authorities.
• Graduate, preferably in Chemistry, Pharmacy or Biological Science;
• Wide range of technical knowledge and experience within the pharmaceutical industry;
• Substantial previous Quality Assurance experience;
• Excellent scientific and technical knowledge;
• Is multi-skilled across a number of areas and has developed specialist expertise relevant to function;
• Up to date knowledge of cGMP, cGDP regulations;
• Team player and ability to work with remote teams;
• English fluency written and spoken (the company language);
• Strong verbal and written communication skills with well-structured communication and presentation ability;
• Strong interpersonal skills;
• Ability to travel 15-20% or more as needed.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
We Respect Your Privacy
Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.
- the process, you may be asked to respond to some questions that will screen your application out if you do not meet certain objective criteria required by the job. You can learn more about this process here.
You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority.
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights
We Respect Your Privacy
Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.
- the process, you may be asked to respond to some questions that will screen your application out if you do not meet certain objective criteria required by the job. You can learn more about this process here.
You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority.
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
Director, Global R&D QA - Qualified Person
InCyte
Job Summary (Primary function)
The focus of this role is to provide QP certification for release of Investigational Medicinal Products (IMP) into the EU.
Job responsibilities may extend to QP certification of commercial products in EU. Qualified Person is responsible for final certification/release of pharmaceutical Products for distribution in EU.
As a member of Incyte Global Quality, QP develops and maintains a strong collaboration with external partners and Incyte cross-functional teams to support implementation of Incyte Quality Initiatives and process improvements.
Essential Functions of the Job (Key responsibilities)
EU/EEA IMP Qualified Person responsibilities include:
Batch release and certification of IMP to be used in EU clinical trials to ensure IMP and its manufacturers comply with the EU Directives and applicable Annexes, Product Specification File and Clinical Trial Applications
o Maintenance of Product Specification File
o Providing QP GMP declarations in support of importation of Medicinal Product into EU
o Review of IMP deviations, complaints and change controls
Batch release and certification of commercial product for EU distribution in accordance with EU Directives and applicable Annexes
Ensures inspection readiness for regulatory inspections including hosting audits, management of inspections/rooms and responses to regulatory agency observations
Perform GMP/GDP audits and Mock PAIs
Responsible for maintaining Incyte GMP Licenses and GMP/GDP activities for medicinal products in EU
Support withdrawal of IMPs
Negotiate QA agreements
Represent Incyte Global QA in cross-functional project team meetings
Collaborate with Regulatory Affairs, Clinical Operations, Global Product and Process Development (Biologics and Small Molecule) to support regulatory submissions and Incyte GMP operations
Collaborate with external partners QA, Responsible Persons (RPs) and QPs
Review regulatory submission documents such as INDs/IMPDs as well as Incyte s responses to Health Authorities requests and/or questions
Participate in develop, implementation and maintenance of Incyte's Quality Management Systems
Develop, review and approve standard operating procedures
Qualifications (Minimal acceptable level of education, work experience, and competency)
Must be fully qualified QP with experience of final certification/release within the EU/EEA. Good knowledge of Quality management (compliance, CAPA, continuous improvement) and international operations. Knowledge of EU regulatory requirements for small molecule and biological products are essential for this role. The ideal person will have the experience and the confidence to interact with Regulatory Authorities.
Graduate, preferably in Chemistry, Pharmacy or Biological Science;
Wide range of technical knowledge and experience within the pharmaceutical industry;
Substantial previous Quality Assurance experience;
Excellent scientific and technical knowledge;
Is multi-skilled across a number of areas and has developed specialist expertise relevant to function;
Up to date knowledge of cGMP, cGDP regulations;
Team player and ability to work with remote teams;
English fluency written and spoken (the company language);
Strong verbal and written communication skills with well-structured communication and presentation ability;
Strong interpersonal skills;
Ability to travel 15-20% or more as needed.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
We Respect Your Privacy
Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.
- the process, you may be asked to respond to some questions that will screen your application out if you do not meet certain objective criteria required by the job. You can learn more about this process here.
You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.
You can learn more about Incyte s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte s data protection officer, and your supervisory authority.
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights
We Respect Your Privacy
Learn more at: http://www.incyte.com/privacy-policy
The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate.
- the process, you may be asked to respond to some questions that will screen your application out if you do not meet certain objective criteria required by the job. You can learn more about this process here.
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You can learn more about Incyte s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte s data protection officer, and your supervisory authority.
Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
Global Operational Risk Manager
IMC Financial Markets
AmsterdamWHO WE ARE AND WHAT WE DO
IMC is a leading global market maker, using algorithmic trading and advanced technology to buy and sell securities on multiple trading venues worldwide. We provide liquidity to the financial markets, driving efficiencies for buyers and sellers.
Founded in 1989, we are an ambitious, innovative company and identified early on the importance technology would play in the fast-paced evolution of trading. This entrepreneurial spirit still drives us today and can be found in all of our offices around the world.
OUR TEAM
We now operate globally from offices in Europe, the US and Asia Pacific. Our employees work closely together in multidisciplinary teams, making our success possible.
Technology - At IMC, technology is not a department, it is at the heart of everything we do. Our technologists push the limits of possibility, and then look beyond. In our fast-paced environment, short feedback loops mean projects worked on in the morning can enter production the next day.
Trading – Although our traders come from many backgrounds they all have one thing in common: they are at their best solving complex problems. Their insight into global events, market shifts and pricing ensure we are trading in the right place, at the right time.
Business Support - Around the world, IMC’s business support teams are essential for sustaining our success. In our dynamic environment, we have many exciting challenges and multidisciplinary opportunities to shape our operations and make a real impact.
OUR CULTURE
Our employees are our greatest asset so we give them lots of responsibility and the support they need to make a difference. Our flat structure fosters a culture of openness and collaboration, encouraging the sharing of ideas and knowledge. It makes no difference if you have been with us for three days or three years, the best idea wins.
While we work hard, we also have a lot of fun; whether solving complex challenges or in team building, leisure and sporting activities. IMC also enables its employees to contribute towards a better society through our foundation.
WHAT YOU’LL DO
The Global Operational Risk Manager operates at Group level with a focus on the optimization of the Operational Risk and Control Framework for IMC and reports directly to the Group Chief Risk Officer. Our Risk Management teams operate closely with the Trading and Technology teams in order to manage the inherent risks in IMC’s trading strategies across various technologies. The Risk Management team is responsible for identifying and assessing risks, determining adequate controls and developing risk metrics and tools to monitor these risks.
The role is based in Amsterdam but will also require travelling to our offices in the US and APAC.
To excel in this role you will combine your risk management expertise and analytical skills to add value without creating bureaucracy to the business.
We are looking for someone who can bring expertise and at the same time has a critical, proactive, and hands-on approach.
Your tasks will include but not be limited to:
- Maintenance and optimize IMC’ s Control Framework
- Work closely with regional risk, trading and development teams
- Assist in evaluating the design and operating effectiveness of controls
- Support in the investigation of the root causes of critical operational incidents and provide support to mitigate risk
- Development of key risk indicators and enhance current global risk dashboards
- Facilitate global periodical risk self-assessments to improve internal processes, policies and procedures
- Maintain documentation for risk management and risk policies and procedures
- Contribute to yearly internal capital adequacy assessment process (ICAAP)
- Promoting a strong operational risk culture across the business
- Keep abreast of latest operational risk management techniques and industry best practices
WHAT WE LOOK FOR:
- University degree
- > 5 years of relevant experience in a similar role in the finance industry
- Broad interest in financial markets and (operational) risk management
- Process minded and ability to improve IMC’s control framework
- Strong analytical / problem solving skills;
- Project management skills, hands on mentality and stakeholder management qualities
- Ability to act and perform successfully in a fast-moving and high-pressured environment
- Strong verbal and written communication skills in English
OUR HIRING PROCESS
To set you up for success, you can find our hiring process including tips on applying and interviewing with us on our website. Now it’s up to you! Apply today to start an amazing journey with IMC.
WHO WE ARE AND WHAT WE DO
IMC is a leading global market maker, using algorithmic trading and advanced technology to buy and sell securities on multiple trading venues worldwide. We provide liquidity to the financial markets, driving efficiencies for buyers and sellers.
Founded in 1989, we are an ambitious, innovative company and identified early on the importance technology would play in the fast-paced evolution of trading. This entrepreneurial spirit still drives us today and can be found in all of our offices around the world.
OUR TEAM
We now operate globally from offices in Europe, the US and Asia Pacific. Our employees work closely together in multidisciplinary teams, making our success possible.
Technology - At IMC, technology is not a department, it is at the heart of everything we do. Our technologists push the limits of possibility, and then look beyond. In our fast-paced environment, short feedback loops mean projects worked on in the morning can enter production the next day.
Trading – Although our traders come from many backgrounds they all have one thing in common: they are at their best solving complex problems. Their insight into global events, market shifts and pricing ensure we are trading in the right place, at the right time.
Business Support - Around the world, IMC’s business support teams are essential for sustaining our success. In our dynamic environment, we have many exciting challenges and multidisciplinary opportunities to shape our operations and make a real impact.
OUR CULTURE
Our employees are our greatest asset so we give them lots of responsibility and the support they need to make a difference. Our flat structure fosters a culture of openness and collaboration, encouraging the sharing of ideas and knowledge. It makes no difference if you have been with us for three days or three years, the best idea wins.
While we work hard, we also have a lot of fun; whether solving complex challenges or in team building, leisure and sporting activities. IMC also enables its employees to contribute towards a better society through our foundation.
WHAT YOU’LL DO
The Global Operational Risk Manager operates at Group level with a focus on the optimization of the Operational Risk and Control Framework for IMC and reports directly to the Group Chief Risk Officer. Our Risk Management teams operate closely with the Trading and Technology teams in order to manage the inherent risks in IMC’s trading strategies across various technologies. The Risk Management team is responsible for identifying and assessing risks, determining adequate controls and developing risk metrics and tools to monitor these risks.
The role is based in Amsterdam but will also require travelling to our offices in the US and APAC.
To excel in this role you will combine your risk management expertise and analytical skills to add value without creating bureaucracy to the business.
We are looking for someone who can bring expertise and at the same time has a critical, proactive, and hands-on approach.
Your tasks will include but not be limited to:
- Maintenance and optimize IMC’ s Control Framework
- Work closely with regional risk, trading and development teams
- Assist in evaluating the design and operating effectiveness of controls
- Support in the investigation of the root causes of critical operational incidents and provide support to mitigate risk
- Development of key risk indicators and enhance current global risk dashboards
- Facilitate global periodical risk self-assessments to improve internal processes, policies and procedures
- Maintain documentation for risk management and risk policies and procedures
- Contribute to yearly internal capital adequacy assessment process (ICAAP)
- Promoting a strong operational risk culture across the business
- Keep abreast of latest operational risk management techniques and industry best practices
WHAT WE LOOK FOR:
- University degree
- > 5 years of relevant experience in a similar role in the finance industry
- Broad interest in financial markets and (operational) risk management
- Process minded and ability to improve IMC’s control framework
- Strong analytical / problem solving skills;
- Project management skills, hands on mentality and stakeholder management qualities
- Ability to act and perform successfully in a fast-moving and high-pressured environment
- Strong verbal and written communication skills in English
OUR HIRING PROCESS
To set you up for success, you can find our hiring process including tips on applying and interviewing with us on our website. Now it’s up to you! Apply today to start an amazing journey with IMC.
Director, Restructuring & Turnaround
Alvarez and Marsal
AmsterdamDirector, Restructuring & Turnaround
Alvarez & Marsal
Amsterdam
Alvarez & Marsal (“A&M”) is a global consulting firm with more than $2+ billion in revenues, over 5,000 staff and 60 offices around the globe and a broad range of professional services including Financial & Operational Restructuring, Debt Advisory, Transaction Advisory, Performance Improvement, Corporate Transformation, Financial Institutions Advisory, Tax, Valuations and Disputes and Investigation Services.
Companies, investors and government entities around the world turn to Alvarez & Marsal (A&M) for leadership, action and results.
A&M has successfully managed some of the largest crises in the world (Lehman Brothers and Arthur Anderson), as well as preserving iconic brands through restructuring (e.g. Gibson Brands). We have earned multiple industry awards including the Turnaround Management Association’s (TMA’s) 2019 Turnaround of the Year: International Company - Seadrill Limited.
The A&M European Restructuring & Turnaround team has focused on big ticket company side financial and operational restructuring assignments in addition to Chief Restructuring Officer (CRO) /CEO/ CFO appointments and, within the last few years, we have delivered on some of Europe’s largest restructuring cases such as Abengoa, Heijmans, Bouwfonds, Intertoys, Toys R Us, Nyrstar, Seadrill, Macintosh, and Continental Foods in addition to working for leading Private Equity companies.
We are seeking a talented, ambitious and experienced Restructuring Director with a CFO skill set and experience of working in distressed environments for our Amsterdam based team.
As a Restructuring Director at A&M, you will have the opportunity to work with experienced Managing Directors and Senior Directors and drive changes that preserve and create value, impacting the world’s most recognized organizations and their employees.
A&M advise on every aspect of the restructuring process – from the strategy, to cash conservation/liquidity management, to business plan development and implementation – providing you with a wide range of experiences and projects.
You will have the opportunity to work across all phases and aspects of operational restructuring and turnaround initiatives. You will stabilise core operations by formulating and managing turnaround plans and negotiating with senior management and other key stakeholders. Working day-to-day alongside our clients, you will develop an in-depth understanding of their processes, financial position and key operational performance drivers. This understanding is needed in order to create and implement successful restructuring and turnaround initiatives.
Key responsibilities will include:
- Developing and executing restructuring and turnaround plans to improve an organization’s overall performance and enterprise value
- Conducting an initial rapid diagnostic into the company's immediate and future cash needs, product profitability, cost base, major operational issues, market position and options for restructuring
- Performing and overseeing analysis on company business plans
- Reviewing and presenting 13-week Cash Flow and 3 Statement Financial models to clients
- Leading clients through various processes, including making working capital improvements, liquidation analysis, credit agreement negotiations and bankruptcy preparation
- Assessing key business operational performance drivers
- Developing and reviewing cost reduction initiatives and execution milestones
- Implementing cash conservation guidelines and controls
The successful candidate will be adept at building a 13 week cash flow forecasts and will have a firm understanding of liquidity management. A working knowledge of corporate finance in restructurings and insolvency regimes is preferable as is an understanding of P&L and asset efficiency (working capital) performance improvement processes.
Applicants must have;
- Training at a Big 4 firm ideally with experience within the Restructuring or Deals team
- A Bachelor’s degree from an accredited university
- Fluency in Dutch is ideal (other European languages are highly desirable)
- Excellent written and verbal communications skills
- Objective, fact-based approach to problem solving
At A&M you will have the opportunity to work on the most disruptive restructuring and turnaround projects in the Netherlands and across Europe. You will work alongside senior management and a team of experienced A&M professionals from a variety of backgrounds that bring a wealth of industry depth and knowledge. Relying on your ability to effectively handle pressure in stressful situations and prioritize multiple work streams, you will work in a fast paced, deeply collaborative team environment.
Ideally, a Director will be able to successfully identify client needs and win client trust. Ultimately, the successful appointee will be recognised by the client as the lead for value contributed on engagements and therefore build his/her own credible network of contacts and referral sources with clients, professionals and institutions.
Diversity & Inclusion
A&M’s entrepreneurial culture celebrates independent thinkers and doers who can positively impact our clients and shape our industry. The collaborative environment and engaging work—guided by A&M’s core values of Integrity, Quality, Objectivity, Fun, Personal Reward, and Inclusive Diversity—are the main reasons our people love working at A&M. Inclusive Diversity means we embrace diversity and we foster inclusiveness. It runs through how we recruit, develop employees, conduct business, support clients, and partner with vendors. It is the A&M way.
Voluntary Inclusion
It is Alvarez & Marsal’s policy to provide and promote equal opportunity in employment, compensation, and other terms and conditions of employment without discrimination because of race, color, sex, sexual orientation,gender identity,family medical history or genetic information, political affiliation, military service, pregnancy, marital status, family status, religion, national origin, age or disability or any other non-merit based factor in accordance with all applicable laws and regulations.
Unsolicited Resumes from Third-Party Recruiters
Please note that as per A&M policy, we do not accept unsolicited resumes from third-party recruiters unless such recruiters were engaged to provide candidates for a specified opening. Any employment agency, person or entity that submits an unsolicited resume does so with the understanding that A&M will have the right to hire that applicant at its discretion without any fee owed to the submitting employment agency, person or entity.
Director, Restructuring & Turnaround
Alvarez & Marsal
Amsterdam
Alvarez & Marsal (“A&M”) is a global consulting firm with more than $2+ billion in revenues, over 5,000 staff and 60 offices around the globe and a broad range of professional services including Financial & Operational Restructuring, Debt Advisory, Transaction Advisory, Performance Improvement, Corporate Transformation, Financial Institutions Advisory, Tax, Valuations and Disputes and Investigation Services.
Companies, investors and government entities around the world turn to Alvarez & Marsal (A&M) for leadership, action and results.
A&M has successfully managed some of the largest crises in the world (Lehman Brothers and Arthur Anderson), as well as preserving iconic brands through restructuring (e.g. Gibson Brands). We have earned multiple industry awards including the Turnaround Management Association’s (TMA’s) 2019 Turnaround of the Year: International Company - Seadrill Limited.
The A&M European Restructuring & Turnaround team has focused on big ticket company side financial and operational restructuring assignments in addition to Chief Restructuring Officer (CRO) /CEO/ CFO appointments and, within the last few years, we have delivered on some of Europe’s largest restructuring cases such as Abengoa, Heijmans, Bouwfonds, Intertoys, Toys R Us, Nyrstar, Seadrill, Macintosh, and Continental Foods in addition to working for leading Private Equity companies.
We are seeking a talented, ambitious and experienced Restructuring Director with a CFO skill set and experience of working in distressed environments for our Amsterdam based team.
As a Restructuring Director at A&M, you will have the opportunity to work with experienced Managing Directors and Senior Directors and drive changes that preserve and create value, impacting the world’s most recognized organizations and their employees.
A&M advise on every aspect of the restructuring process – from the strategy, to cash conservation/liquidity management, to business plan development and implementation – providing you with a wide range of experiences and projects.
You will have the opportunity to work across all phases and aspects of operational restructuring and turnaround initiatives. You will stabilise core operations by formulating and managing turnaround plans and negotiating with senior management and other key stakeholders. Working day-to-day alongside our clients, you will develop an in-depth understanding of their processes, financial position and key operational performance drivers. This understanding is needed in order to create and implement successful restructuring and turnaround initiatives.
Key responsibilities will include:
- Developing and executing restructuring and turnaround plans to improve an organization’s overall performance and enterprise value
- Conducting an initial rapid diagnostic into the company's immediate and future cash needs, product profitability, cost base, major operational issues, market position and options for restructuring
- Performing and overseeing analysis on company business plans
- Reviewing and presenting 13-week Cash Flow and 3 Statement Financial models to clients
- Leading clients through various processes, including making working capital improvements, liquidation analysis, credit agreement negotiations and bankruptcy preparation
- Assessing key business operational performance drivers
- Developing and reviewing cost reduction initiatives and execution milestones
- Implementing cash conservation guidelines and controls
The successful candidate will be adept at building a 13 week cash flow forecasts and will have a firm understanding of liquidity management. A working knowledge of corporate finance in restructurings and insolvency regimes is preferable as is an understanding of P&L and asset efficiency (working capital) performance improvement processes.
Applicants must have;
- Training at a Big 4 firm ideally with experience within the Restructuring or Deals team
- A Bachelor’s degree from an accredited university
- Fluency in Dutch is ideal (other European languages are highly desirable)
- Excellent written and verbal communications skills
- Objective, fact-based approach to problem solving
At A&M you will have the opportunity to work on the most disruptive restructuring and turnaround projects in the Netherlands and across Europe. You will work alongside senior management and a team of experienced A&M professionals from a variety of backgrounds that bring a wealth of industry depth and knowledge. Relying on your ability to effectively handle pressure in stressful situations and prioritize multiple work streams, you will work in a fast paced, deeply collaborative team environment.
Ideally, a Director will be able to successfully identify client needs and win client trust. Ultimately, the successful appointee will be recognised by the client as the lead for value contributed on engagements and therefore build his/her own credible network of contacts and referral sources with clients, professionals and institutions.
Diversity & Inclusion
A&M’s entrepreneurial culture celebrates independent thinkers and doers who can positively impact our clients and shape our industry. The collaborative environment and engaging work—guided by A&M’s core values of Integrity, Quality, Objectivity, Fun, Personal Reward, and Inclusive Diversity—are the main reasons our people love working at A&M. Inclusive Diversity means we embrace diversity and we foster inclusiveness. It runs through how we recruit, develop employees, conduct business, support clients, and partner with vendors. It is the A&M way.
Voluntary Inclusion
It is Alvarez & Marsal’s policy to provide and promote equal opportunity in employment, compensation, and other terms and conditions of employment without discrimination because of race, color, sex, sexual orientation,gender identity,family medical history or genetic information, political affiliation, military service, pregnancy, marital status, family status, religion, national origin, age or disability or any other non-merit based factor in accordance with all applicable laws and regulations.
Unsolicited Resumes from Third-Party Recruiters
Please note that as per A&M policy, we do not accept unsolicited resumes from third-party recruiters unless such recruiters were engaged to provide candidates for a specified opening. Any employment agency, person or entity that submits an unsolicited resume does so with the understanding that A&M will have the right to hire that applicant at its discretion without any fee owed to the submitting employment agency, person or entity.
Salaris
€2.704k - €3.588k Per maand
Type functie
Fulltime
Geplaatst op
19 dagen geleden
Beschrijving
Het komende jaar kun jij een leuke baan in je bezit hebben! Doe je het goed, zeker wel langer!
Stichting Lira, die eerlijke vergoedingen voor tekstmakers uitbetaald, is op zoek naar een beleidsmedewerker voor 32-38 uur in week.
- uitzicht op vaste baan
- salaris o.b.v. ervaring
- flexibele werktijden
- uitdagende en afwisselende baan
- informele en collegiale bedrijfscultuur
- werken vanuit huis
Heb jij een bedrijfskundige en/of juridische achtergrond op minstens HBO niveau?Heb je minimaal 3 jaar relevante (beleidsondersteunende) werkervaring? Dan zijn wij op zoek naar jou!
- HBO opleiding met juridische en/of bedrijfskundige achtergrond
- minstens 3 jaar ervaring in een (politieke) functie waarin gecompliceerde administratieve processen een belangrijke rol spelen
- ervaring met voorbereiden en schrijven van beleidsnotities
- ervaring met projectmatig werken en/of het begeleiden van een project.
- je bent analytisch en hebt cijfermatig inzicht
Je komt te werken in een politieke omgeving. In het sterk veranderende digitale landschap vinden steeds meer vormen van exploitatie van auteursrechtelijk beschermd werk plaats.
Jij komt in deze functie op voor een rechtvaardige vergoeding voor tekstmakers.
Achter de schermen zal jij onderdeel uitmaken van de processen om dit allemaal rond te krijgen. Als spil in het web zorg jij dat er overzicht is. Communiceer je duidelijk met alle betrokken partijen en kijk je kritisch naar de processen en hoe die verbetert kunnen worden.
- het beleidsmatig optimaliseren van incassomogelijkheden, in binnen- en buitenland, en de verdeling van de geïncasseerde gelden aan tekstmakers.
- Het onderhandelen met gebruikers en licentiehouders van auteursrechtelijk beschermde werken.
- Het analyseren van de uitgevoerde uitkeringen.
- Het afstemmen van de werkzaamheden met backoffice en ondersteunende stafafdelingen
- het begeleiden en coördineren van onderzoeken naar gebruik van auteursrechtelijk beschermd materiaal.
- algemene (beleids-) initiërende en ondersteunende werkzaamheden.
- communicatie verbeteren en optimaliseren van externe communicatie, waaronder de website, de webportal en social media.
- behandelen van vragen van relaties.
Cedar is de serviceorganisatie van 7 auterusrecht-stichtingen. Jij zal komen te werken voor de Stichting Lira. Het team bestaat uit de directeur en adjunct directeur en een collega-beleidsmedewerker. Het is een klein team met veel toewijding aan het werk.
- nauwe samenwerking in een klein team.
- collegiaal en informele bedrijfscultuur.
Bezit jij over bovengenoemde ervaring en kennis? Solliciteer dan direct en dan nemen wij z.s.m. contact met je op!
Toch nog vragen? Stel ze gerust en stuur mij een mailtje of bel mij op.
Vacaturenummer: 456757