vacature overig

Recruitment Consultant voor vaste en tijdelijke functies (0,8 – 1,0 fte)

Aanbod
  • werken in een succesvolle en groeiende dienstverlenende organisatie;
  • een enthousiast team van collega’s;
  • open cultuur en sfeer, waardoor je waarschijnlijk snel je plek zal vinden binnen het team;
  • breed takenpakket met grote mate van verantwoordelijkheid;
  • ruimte voor opleiding en ontwikkeling;
  • samen met collega’s verantwoordelijk zijn voor het resultaat;
  • op of uitbouwen van een netwerk binnen de life sciences en gezondheidszorg;
  • gunstige pensioenregeling;
  • salaris dat past bij de ervaring en het eventuele netwerk dat je meebrengt.
Bedrijf

Derks & Derks brengt als strategisch partner in human talent, organisaties en hoger opgeleide talenten in Life Sciences en gezondheidszorg samen. Werving & Selectie, Detachering & Interim, Talent Development, HR Research en Opleiding & Training vormen de kern van onze dienstverlening. Persoonlijke aandacht, heldere afspraken, integriteit en strikte kwaliteitsnormen, vormen daarin altijd de basis. Met een breed netwerk en sterke vak- en branchekennis, zijn wij dé strategisch partner in human talent.

Om onze rol als specialist in Life Sciences steeds breder in te vullen en in te spelen op marktontwikkelingen, hebben we de afgelopen jaren diverse innovatieve projecten in deze markt gelanceerd:

  • Masterclass NieuweZorg (verheldering en verdieping voor iedereen die meer wil betekenen voor de zorg)
  • Leergang Industriële Farmacie (praktijkgerichte professionalisering in de farmaceutische industrie)
  • FMF-vacatures (alle HBO+ vacatures in Life Sciences online beschikbaar)
  • INRALS (internationaal netwerk van werving- & selectiebureaus in Life Sciences)

Onze kernwaarden zijn: samen het beste resultaat, team van experts, betrouwbare partner en kwaliteit verzekerd. De cultuur is hands-on, klantgericht, informeel en betrokken. Er wordt hard gewerkt, maar ook veel gelachen. Om ons team van experts uit te breiden zijn we op zoek naar een gedreven, professionele en enthousiaste Consultant, die graag bijdraagt aan de gezamenlijke doelstellingen van de afdeling.

Functie

In de functie van Consultant ben je gesprekspartner voor onze opdrachtgevers en professionals op zoek naar een nieuwe uitdaging. Aan jou de taak om te zorgen voor de juiste match. Je helpt de professional met het vinden van de juiste baan en eventuele vervolgstappen in zijn/haar carrière binnen de branche. Tevens ben je strategisch partner voor de opdrachtgevers waarvoor je werkt. Je adviseert, waar mogelijk bij HR gerelateerde vraagstukken, of informeert over de andere ondersteunende diensten en opleidingen van Derks & Derks. Je moet snel kunnen schakelen en meerdere ballen in de lucht kunnen houden. Je takenpakket bestaat onder andere uit het op- en uitbouwen van nieuwe en bestaande relaties, opstellen van plan van aanpak, coördineren van opdrachten, schrijven van wervende vacatureteksten, searchen en interviewen.

Profiel
  • hbo/wo werk- en denkniveau;
  • bij voorkeur ervaring in vergelijkbare functie, kennis van recruitment (branchekennis is niet vereist);
  • representatief, proactief, daadkrachtig, mensgericht en betrokken;
  • commerciële instelling;
  • verbinder, weet de juiste match te maken;
  • goede beheersing van Nederlandse en Engelse taal;
  • gezonde dosis humor.
Reactie

Geïnteresseerd? Stuur je curriculum vitae en motivatie, onder vermelding van referentienummer WL/17-131-DD naar Sandra van Putten, info@derksenderks.nl. Voor meer informatie kun je contact opnemen met Sandra of Pieter via 033 – 4728087. Een assessment maakt deel uit van de selectiemethode.

Senior Contract Manager (procurement)

Offer

  • an amazing opportunity to use your skills and experience by cooperating with this client
  • a quality orientated organisation in the pharmaceutical industry
  • working in an international environment
  • a temporary contract or an independent contract from Derks & Derks
  • a contract for 6 months with the possibility to extent

Organisation

The organisation is an international pharmaceutical organisation that is operating in more than 40 countries across Europe, the Middle East and Africa. They operate on a global level and most of the teams have a global focus. They do research, development, manufacturing, warehousing but also sales and marketing. They hope to change ‘tomorrow’ and to improve the lives of individuals by providing innovative medicines in areas of health where there is an urgent need for better treatments. The organisation is clearly focused on bringing high quality medicines to the market to reach their goals. Wouldn`t it be lovely to join them in their journey? At this moment they are open to meet an enthusiastic candidate for a temporary position as Senior Contract Manager at their office in Leiden.

Position

As a Senior Contract Manager you will provide integrated contract language and strategic advice on complex agreements, and other legal/contract documents. You are going to take independent decisions on the contractual and commercial risks involved, in support of activities for assigned projects, teams, departments, and/or division. In your role you will ensure that the contracts are following legal and compliance policies.  You will be responsible for developing and reviewing contract language for assigned contracts, including but not limited to Health Care Professional (HCP) consulting, confidentiality agreements, vendor and research institution agreements, Investigator Sponsored Research, and Master Services Agreements.  This role will facilitate expedient review and resolution of negotiated clauses with parties to help ensure business continuity while remaining compliant and within established guidelines and processes.  You will interface with Legal, Risk Management, Ethics & Compliance and other internal and external stakeholders as required to resolve issues. You will also contribute to the improvement of the contract process, templates, and playbooks by participating in various committees and work streams comprised of members.

Profile

  • must have a BS or a BA degree in business law or healthcare law or a related field
  • minimum 7 years of experience with global contract negotiation, analysis, and interpretation
  • relational understanding of the critical path of drug development process
  • excellent interpersonal, oral, and written communication skills
  • demonstrated and proven experience leading individuals and/or teams in the delivery of results
  • strong attention to detail
  • ability to work in a matrix environment
  • ability to deliver quality while working under pressure and be able to deliver tasks against strict deadlines
  • must be able manage multiple competing projects from multiple client groups globally
  • ability to analyse complex legal issues
  • ability to quickly acquire knowledge of unfamiliar fields of law in a global setting
  • computer literacy, including Microsoft Office Suite
  • must be self-motivated and conscious of both the quality and the scheduling of the work
  • ability to function autonomously with little supervision
  • fluent in the English language, both written and oral

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-066-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Hoofd Ziekenhuisapotheek

Aanbod

  • invloedrijke positie met breed pakket aan taken en verantwoordelijkheden;
  • uitdagende veranderopdracht naar een integrale ziekenhuisapotheek;
  • verantwoordelijk voor de aansturing van 250 fte;
  • maakt onderdeel uit van medische staf van top klinisch ziekenhuis;
  • competitieve arbeidsvoorwaarden.

Bedrijf

Het Albert Schweitzer ziekenhuis is een modern en vooruitstrevend ziekenhuis met locaties in Dordrecht, Zwijndrecht en Sliedrecht, en een buitenpolikliniek in Ridderkerk. De organisatie telt 250 medisch specialisten en een kleine 4.000 medewerkers en maakt deel uit van de Samenwerkende Topklinische opleidings Ziekenhuizen(STZ). Dat betekent dat er in het ziekenhuis en de apotheek talent opgeleid wordt en dat de organisatie zich onderscheidt met patiëntgericht wetenschappelijk onderzoek en hoogwaardige zorg. Het ASz werkt intensief samen met zorgverleners en ziekenhuizen in de regio, zoals het Amphiaziekenhuis, Bravis en Rivas.

Het Albert Schweitzer ziekenhuis heeft bij de oprichting een visie ontwikkeld die nog altijd richtinggevend is voor strategie en beleid: “Zorg met hoofd, hart en ziel”. In de ambities van het ziekenhuis wordt integraal gedacht en vormen de wensen en belangen van de patiënt altijd het uitgangspunt. De apotheek vormt een belangrijk onderdeel in de patiëntenzorg van het ASz en er is een substantieel deel van het ziekenhuisbudget mee gemoeid. De ziekenhuisapotheek bestaat uit de klinische ziekenhuisapotheek en de poliklinische apotheek. Daarbij heeft het ASz in samenwerking met het Amphia Ziekenhuis een succesvolle eigen productie apotheek A+ die ook andere zorgverleners bedient.

Besloten is om de ziekenhuis-en poli-apotheek te integreren tot één ziekenhuisapotheek die het totale pallet van farmaceutische zorg levert, onafhankelijk van waar de patiënt zich bevindt. Het gaat om een organisatie ‘in wording’. Een Farmaceutisch Integratie Team, bestaande uit ziekenhuis-en poliapothekers, denkt na over de gewenste toekomstige inrichting, de voordelen in kwaliteit en bedrijfsvoering en de uitdagingen voor integratie. De nieuwe integrale ziekenhuisapotheek wordt geleid door een duaal bestuur, bestaande uit een Hoofd Ziekenhuisapotheek en een Bedrijfskundig Manager.

Functie

Het Hoofd Ziekenhuisapotheek en de Bedrijfskundig Manager zijn als collegiaal bestuur verantwoordelijk voor de integrale ziekenhuisapotheek en haar taken en verantwoordelijkheden. Het Hoofd Ziekenhuisapotheek is eindverantwoordelijk op inhoud voor kwalitatief hoogwaardige farmaceutische zorg en een klantgerichte dienstverlening. Dit gaat om inkoop, bereiding, distributie, poliklinische apotheken, laboratorium en productie. Het Hoofd Ziekenhuisapotheek is direct leidinggevende van de apothekers en tevens meewerkend ziekenhuisapotheker. Hij/zij stuurt in beleid, uitvoering en management op kwaliteit, patiëntveiligheid en patiënttevredenheid. Intensieve samenwerking wordt gevraagd, zowel met de Bedrijfskundig Manager, als met de stakeholders binnen de eigen afdeling, in het ziekenhuis en in de zorgketen. Het Hoofd Ziekenhuisapotheek is samen met de Bedrijfskundig Manager verantwoordelijk voor een voorspoedige implementatie van de nieuwe organisatiestructuur, inclusief bijhorende processen en (samen)werk afspraken.

De unieke kwaliteiten van de poliklinische apotheek en de ziekenhuisapotheek worden hierbij benut en gedeeld. Respect en leren van elkaar staan hoog in het vaandel. Het Hoofd Ziekenhuisapotheek rapporteert direct aan de Raad van bestuur.

Profiel

  • brede ervaring en een hoog ambitieniveau op alle onderdelen van de ziekenhuisfarmacie;
  • geregistreerd ziekenhuisapotheker, minimaal 10 jaar ervaring als apotheker;
  • minimaal vijf jaar leidinggevende ervaring;
  • als leidinggevende stevig en verbindend;
  • v.k.-ervaring met inkoop, zorgverzekeraars en leveranciers;
  • v.k.-ervaring in een omgeving waar de klinische en poliklinische farmaceutische zorg geïntegreerd aangeboden wordt;
  • ervaring met afstemming, overleg, onderhandeling en stakeholdermanagement;
  • visie op de toekomst van de ziekenhuisfarmacie;
  • bedrijfsmatig inzicht (personeel, organisatie, financiën).

Reactie

Geïnteresseerd? Stuur je curriculum vitae en motivatie, onder vermelding van referentienummer WS/20-040-DD, naar Alexander Willemse, info@derksenderks.nl.

Voor meer informatie kun je bellen met Alexander Willemse via 033 – 4728087 of 06-12795418

Voor de werving van deze positie werken wij nauw samen met Ebbinge. Een referentieonderzoek en assessment kunnen deel uitmaken van het selectieproces.

Is dit niet helemaal de functie die je zoekt? Kijk dan op http://www.derksenderks.nl/nl/nieuwe-baan/vacatures voor andere interessante vacatures!

Associate QMS Manager

Offer

  • a diverse job at a global pharmaceutical company
  • an interesting job because of the international contacts
  • a temporary contract for 6 months, with the possibility to extend

Organisation

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has tight lines all around the world. The organisation is looking for an Associate QMS Manager.

Position

As an Associate QMS Manager you will work under limited supervision or completely independent. In this role it will be your responsibility to implement operational plans for your region. You will support global audits and inspections and deliver on process improvement. You will also be involved at process compliance matters as well as KPI management and Metrics. Delivering support to the management and maintenance of controlled safety documents like SOP are also included in your tasks. You will collaborate with relevant GPV and non GPV partners on a global level. Next to that you will participate in projects related to Audit and Inspection management and Process Improvement. As well as Controlled Document management and/or Compliance management. You will be representing QMS and taking ownership for specific tasks and deliverables. You will make sure they are to ensure oversight as well as compliant with all applicable worldwide pharmacovigilance regulations and internal and external KPIs. In this role you report to the Global Lead QMS or Process Improvement Team Lead.

Profile

  • Minimum BA/BS.
  • At least 4 years within a pharmaceutical, biotechnology or related industry.
  • Minimum 2 years’ of experience in Pharmacovigilance (e.g. in case processing), Regulatory affairs or Safety Quality Assurance, preferably experience in support of the safety quality systems.
  • Understanding of safety regulations for both marketed and investigational products, and excellent knowledge of global health authority requirements including ICH, CFR 21, FDAAA, EU GVP module, JP regulations.
  • Experience and understanding of Process Management, Standards, Training & IT function as they apply throughout the entire pharmaceutical compound/product life cycle.
  • Good understanding of PV and Clinical Research processes, and other processes making up the PV system.
  • including the interfaces between these processes.
  • Very good understanding of PV, data management and adverse event reporting and processing.
  • Excellent oral and written communication skills, ability to interact with all levels of personnel.
  • Must be able to communicate in English (active and passive), other languages considered an asset.
  • Computer literacy (including Microsoft Office, Access and Project).

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-065-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Drug Safety Officer

Offer

  • a diverse job at a global pharmaceutical company
  • an interesting job because of the international contacts
  • a temporary contract for 7 months, with the possibility to extend

Organisation

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has tight lines all around the world. The organisation is looking for a Drug Safety Officer.

Position

As a Drug Safety Officer you will be managing its related duties and act as a contact person for any safety issues at the responsible country and/or Affiliate. You will lead and, if applicable, provide effective management of PSI. Ensure that safety information (Adverse Events) received from all sources by the Affiliate are collected, translated and forwarded to designated Regional PV HQ, in compliance with required timelines (reporting timelines), quality guidelines and standards. If applicable: Timely ICRS submissions to the Competent Authority. You will also ensure the Affiliate is GPvP inspection and audit ready and support a PV audit or inspection if needed. Another field  of responsibility is to provide input for the PSMF regarding the Affiliate communication to GPV Regional HQ. You will also be responsible and accountable for PV self-assessments, PV audits/inspections at the Affiliate and assist in developing CAPAs (with qualitative/quantative measures and timelines) in response to findings/observations. If the position is not various enough you also serve as a point of contact for the PV Regional HQ functions, PV Affiliate Support Function, the Affiliate MT and M&D functions. You report to the manager of the department and interact with your global and local team.

Profile

  • minimum B.Sc. degree in Life Sciences
  • in depth knowledge of regulatory requirements
  • technical expert or manager with an in-depth understanding of all aspects of pharmacovigilance and related disciplines
  • experience in leading a team, project or process function
  • a strong cultural sensitivity, influencing skills without direct hierarchy
  • good oral and written communication and presentation skills in English
  • willingness to travel up to 50%

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-064-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Is this not the job you are looking for? Please visit www.derksenderks.nl/nl/nieuwe-baan/vacatures for other challenging positions in pharma, food and medical.

Director Commercial Quality / QP

Offer
  • strategic management position
  • responsible for 8 countries
  • working for a company with a diverse and interesting product portfolio
  • attractive remuneration package
Organisation

Our client manufactures and markets high-quality drugs in a diversity of fields. With a diverse portfolio of products and solutions, they are continuously providing patient healthcare solutions. They have built a promising pipeline centered around their core therapeutic areas. Through continuous investment in their research and development, marketing and business development, they keep growing their medicines business. Innovation is at the core of this company, with the aim of improving health and contributing to better, healthier lives. We are currently looking for a Quality Director to complete their European Quality Team.

Position

As a Director Commercial Quality / QP you are responsible for the overall direction, coordination, implementation and execution of commercial quality activities in the Benelux and Nordics. This needs to be in alignment with business units in order to ensure products are efficientlty distributed into the countries by meeting their regional and local standards and customer needs. In this position, you will support the relevant countries to locally roll out their Quality System. You ensure that all relevant local country suppliers/service providers are under control (including but not limited to: QTAs, Audit Program, PQR). You follow and trend-analyze monthly quality metrics in the countries and identify corresponding action plans. Furthermore, you are responsible for business support by participating in the periodic management meeting organized with other supportive functions (Supply Chain, Regulatory Affairs, Pharmacovigilance). When it comes to Critical Quality Incidents, you escalate to the regional quality issues raised at local level and support local quality departments to elaborate and deploy action plans related to quality incidents raised locally or regionally.

As Quality Director, you are responsible for managing and leading the 8 Quality departments, and you also train and provide professional guidance to teams. You define annual objectives in compliance with annual regional quality objectives. This position has 8 direct reports and a total of approximately 20 reports. You will report to the Sr. Director Quality Europe.

Profile
  • Sc. degree in Pharmacy, Biology, Healthcare or equivalent is required; post-graduate or doctoral degree is preferred
  • minimum of 7 years of experience in a Quality Role within the pharmaceutical field, and a minimum of 7 years of experience as a functional leader within an international environment
  • experience or history of being a Qualified Person is required
  • in-depth knowledge of the pharmaceutical industry as it relates to Quality Compliance
  • in-depth understanding of GMP & GDP regulations
  • experience with development and implementation of Quality Systems and application of risk assessment tools
  • strong problem solving skills, autonomous and independent, strong collaboration, management and leadership skills. Able to inspire and motivate a team.
  • excellent communicative skills in English, Dutch is preferred.
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/20-056-DD, to Anneke Aangeenbrug : info@derksenderks.nl.

For further information, please call Anneke Aangeenbrug at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our Client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Regulatory Submission Manager

Offer

  • a diverse job at a global pharmaceutical company
  • an interesting job because of the international contacts
  • a temporary contract for 12 months, with the possibility to extend

Organisation

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has tight lines all around the world. The organisation is looking for a Regulatory Submission Manager.

Position

As a Regulatory Submission Manager you will be responsible for managing the planning, preparation, submission and tracking of correspondence, applications and other structured data to regulatory agencies. You will identify and ensure adherence to relevant submission standards. In addition, you will interact with key personnel within the global Regulatory Affairs organization to resolve procedural and operational complexities. This position also involves execution-focused interactions with regional health authorities and other organizational functions such as Pharmacovigilance, Marketing Operations, Data Science, Supply Chain, Manufacturing and other areas within Medical & Development. You will contribute to cross-functional initiatives (e.g. IT system implementations and process re-engineering projects), and address business problems by identifying resolution options (including the benefits and drawbacks of each possibility). You will also train other staff members on systems and processes, and conduct trainings for new users in RA systems. In this position you will work independently, but also within project teams, committees etc. to attain group goals. You will report to a Senior Manager, Associate Director or Director of Regulatory Operations.

Profile

  • Bachelor’s degree or higher (scientific discipline preferred)
  • at least 3 years of experience in the pharma industry (of which at least 2 years in, or closely related to, Regulatory Operations)
  • experience in working in multidisciplinary teams
  • ability to work independently, prioritize, multi-task and work under pressure with minimal supervision
  • experience with eCTD, NEES and other technical submission formats
  • experience with one or more European procedure types, e.g. CP, MRP/DCP
  • preferably experience with managing IT systems or providing business operational support
  • experience using document management, submission publishing, registration management, labelling and/or change control systems is preferred
  • basic understanding of data warehousing, data lakes and reporting/analytics platforms or concepts
  • Fluent in English, both spoken and written, proficiency in other languages (e.g. Dutch, Japanese, Spanish) is preferred

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-061-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Is this not the job you are looking for? Please visit www.derksenderks.nl/nl/nieuwe-baan/vacatures for other challenging positions in pharma, food and medical.

vacature regulatory-affairs

Senior Manager CMC-RA

Offer
  • a diverse job at a global pharmaceutical company
  • an interesting job because of the international contacts
  • a temporary contract for 1 year, with the possibility to extend
Organisation

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has tight lines all around the world. The organisation is looking for a highly experienced Sr. Manager CMC-RA.

Position

As a Sr. Manager CMC-RA you will support the preparation of variation packages, renewals, new MAA (non-ICH), and response documents concerning both EU and non-EU (i.e. EMEA region) submissions. It concerns both CTD module 3 (and QOS) and Normative Document for small molecules. You will also support the preparation of baseline submissions. In addition, it is your responsibility to contribute to the assessment/comparison of updated ICH/non-ICH file as part of a global compliance project. Furthermore, you will create overviews of available quality modules in order to prepare for migration to another document management system. Finally, you will contribute to the compliance check of CMC-RA information in the applicable systems.

Profile
  • at least 3 years of experience with CMC-RA related preparations for variation packages, renewals, new MAA (non-ICH), and response documents. Preferably, also experience with Normative Document preparation/updates
  • experience with IT systems (like Trackwise, document management system), Excel, Word
  • strong organizational skills, accurate, being able to work independently
  • good communication skills;
  • fluent in English (both written and spoken)
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-060-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Is this not the job you are looking for? Please visit www.derksenderks.nl/nl/nieuwe-baan/vacatures for other challenging positions in pharma, food and medical.

Associate Director Regulatory Affairs

Offer

  • a diverse job at a global pharmaceutical company
  • an interesting job because of the international contacts
  • a temporary contract for 6 months, with the possibility to extend

Organisation

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has tight lines all around the world. The organisation is looking for a highly experienced Associate Director Regulatory Affairs Manager.

Position

As an Associate Director Regulatory Affairs you will be responsible to ensure strategic and operational alignment of RA activities with other functional departments in AP-MENA/SSA and ensure adequate planning and resources to adhere to the targets defined in the Business (Review) Meetings. You will make sure that Regulatory Affairs Managers in AP-MENA/SSA prepare (tailoring for local submission), dispatch to agents and business partners and ensure submission to local authorities and maintain as directed by RAE. You will make sure that Marketing Authorization Applications (MAA) are made according to current legislation, in order to obtain and maintain marketing authorizations in the geographical business area of AP MENA/SSA. This is directly linked to the strategic business obligations of the affiliate to the European objective. You will support the Regulatory Affairs and Quality Director in overall quality improvement and assurance and management of the regulatory group. Together with the Manager you will also have specific regional and product responsibilities and tasks (RAM responsibility). In this position you will work in a small team and report to the director of RA of the MENA/SSA.

Profile

  • Master degree in pharmacy, chemistry of (medical) Biology preferred
  • at least 5 years‘ experience with international RA activities in the pharmaceutical industry
  • preferable additional team leader or project leader experience
  • experience in working in multidisciplinary teams
  • ability to work with well-organized project management, result oriented and working under pressure
  • excellent communication and writing skills (advise, convince, negotiate, listen, coach, present and edit)
  • coaching skills and capability to lead an experts team, with experts working at various levels & experience
  • relatively high abstraction level, to be able to switch to required levels and stand-points
  • ability to generate a realistic work-planning, derived from a vast number of data and information
  • good communication skills (positive & constructive attitude, desire and ability to work in multidisciplinary / international teams)
  • good knowledge of the regulatory rules, guidance and institutes in MENA/SSA territory
  • adequate knowledge to work with information technology systems (e.g. Windows, MS Office and Dbases)
  • Fluent in English language, both spoken and written

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-059-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Is this not the job you are looking for? Please visit www.derksenderks.nl/nl/nieuwe-baan/vacatures for other challenging positions in pharma, food and medical.

Regulatory Operations Associate

Offer

  • a diverse job at a pharmaceutical company
  • an interesting job because of the international contacts
  • a temporary contract for 9 months, with the possibility to extend

Organisation

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has tight lines all around the world. The organisation is looking for a motivated Regulatory Operations Associate.

Position

As a Regulatory Operations Associate you will be responsible to ensure timely preparation and submission of correspondence and applications to regulatory agencies, tracking and planning of such and document conformance to global publishing standards and style manuals. You will also be responsible for timelines and own resource management. You will participate in extended teams/projects/teams and ensure timely internal communication regarding regulatory filing status. In the position you will be considered a specialist in the field of electronic document management & style compliance, submissions management & publishing or regulatory information management. As a member of the project teams / task forces you are considered a regulatory operations expert. You will provide advice on technical quality of submission ready documents and completeness of planning and tracking information. Furthermore, you will ensure compliance with Regulatory Agency rules and guidelines pertaining to regulatory (including electronic) submissions. You will represent Regulatory Operations EU in local project teams. Ongoing maintenance of process documentation associated with Regulatory Operations / publishing activities is also part of your role. You will act as a liaison between members of Regulatory Affairs, QA and Operations in order to ensure timely submission of regulatory compliant and quality documents. Last but not least you will participate in the global testing and piloting of new electronic software tools (to include version upgrades), and submission types. You will supervise contract staff in the conduct of their duties. You will conduct trainings for new users in Regulatory systems and create job aides, process improvements, and training documentation.

 

Profile

  • at least a Bachelor degree
  • Bachelor 1-2 years’ experience and Master 0-2 years’ experience
  • proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members
  • good written and oral communication skills in English
  • high integrity with respect to maintenance of proprietary, confidential information
  • highly accurate and organized, oversees support activities
  • affinity to work with IT systems and a problem solving mentality
  • comes up with improvements by taken initiative and a proactive mentality
  • flexible, stress resistant and a teamplayer

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-058-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.

Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.