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.

Responsible Pharmacist GDP

Aanbod
  • dynamische en internationale werkomgeving;
  • doorgroeimogelijkheden naar een leidinggevende functie;
  • uitdagende werkzaamheden op gebied van proces ontwikkeling;
  • werken in een klein team waar verantwoordelijkheid en zelfstandigheid gewenst zijn;
  • uitstekend pakket primaire en secundaire arbeidsvoorwaarden.
Bedrijf

De organisatie is al meerdere jaren succesvol actief binnen de internationale markt en richt zich met name op de import, opslag, distributie, marketing en verkoop van een kwalitatief hoogwaardig assortiment geneesmiddelen, maar zijn daarnaast ook actief op het gebied van non farma. De organisatie kenmerkt zich al jarenlang door een flexibele, efficiënte en dienstverlenende benadering van de markt, waar kwaliteit een belangrijk onderdeel van is. Om binnen de dynamische markt succesvol te blijven acteren, is het beheer en onderhoud van het gedegen kwaliteitsmanagementsysteem essentieel. Om deze reden is de organisatie op zoek naar een initiatiefrijke, stressbestendige en zelfstartende Responsible Pharmacist, die het als een uitdaging ziet de QA activiteiten zelfstandig te bewaken en het huidige systeem naar een nog hoger plan weet te tillen.

Functie

In de functie van Responsible Pharmacist werk je zelfstandig en ben je verantwoordelijk voor het beheren en overzien van alle kwaliteitsprocessen binnen de organisatie. Daarbij kom je met voorstellen om het bestaande kwaliteitsproces te optimaliseren, zodat er op een effectieve en efficiënte manier gewerkt kan worden. Verder zorg je dat het kwaliteitsdenken ingebed is in de organisatie en zie je erop toe dat de werkzaamheden volgens de geldende richtlijnen (GMP/GDP) en procedures worden uitgevoerd. Je houdt je onder andere bezig met het verifiëren en certificeren van batches van uitgevoerde secundaire verpakkingsactiviteiten. De wet- en regelgeving breng je op pragmatische wijze in compliance met de diverse (internationale) klanteisen, waarbij je de vertaalslag weet te maken naar concrete processen, procedures en systeemwijzigingen. Je ziet erop toe dat de beoordeling en afhandeling van CAPA’s en overige werkzaamheden correct worden uitgevoerd, verder ben je verantwoordelijk voor de root cause analysis en “out of specs” voorbereidingen.

Tot slot wordt je als Responsible Pharmacist mede verantwoordelijk voor de kwaliteit van de distributie en de vrijgifte van de diverse producten. Kortom: dé ideale mix van kwaliteit, hands-on activiteiten/projecten, verbetermanagement en zowel persoonlijke als inhoudelijke ontwikkeling!

Profiel
  • afgeronde wo-opleiding richting (bio)farmacie of (bio)medische richting;
  • meerdere jaren werkervaring in een kwaliteitsfunctie;
  • ingeschreven als QP en/of RP;
  • werkervaring in de farmaceutische, voedingsmiddelen of medische industrie;
  • werkervaring bij een groothandel;
  • kennis van de GMP/GDP werkomgeving;
  • energiek, gedreven, enthousiast;
  • flexibel, gedreven, volhardend, pragmatisch, stressbestendig, inventief en mens- en servicegericht;
  • uitstekende communicatieve en schriftelijke vaardigheden in het Engels en Nederlands.
Reactie

Geïnteresseerd? Stuur je curriculum vitae en motivatie, onder vermelding van referentienummer WL/20-036-DD, naar Sandra van Putten, info@derksenderks.nl. Voor meer informatie kun je bellen met Sandra van Putten via 033 – 4728087.

Een assessment kan deel uitmaken van de selectiemethode.

Onze opdrachtgever heeft er bewust voor gekozen om de procedure door Derks & Derks B.V. te laten behandelen. Wij vragen nadrukkelijk je reactie aan Derks & Derks te richten.

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

vacature sales-marketing

Sr. Market Access Manager (Neuroscience)

Offer
  • challenging role in a biopharmaceutical organisation
  • combined role with Market Access, Stakeholder Management and Corporate Affairs
  • very attractive employment conditions package
Organization

Our client is a leading biotech organisation that discovers, develops and delivers therapies to improve the lives of patients. They offer therapies for neurological diseases, globally, through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. The atmosphere is very open and accessible. This is also reflected in the mutual cooperation, along with their key focus on professionalism and a drive to accomplish the best results for the society. They are currently searching for a Sr. Market Access Manager because of the growing challenges and interesting pipeline of medicines.

Position

As Sr. Manager Market Access you will lead the payer related activities for the organizationals Neuroscience (Alzheimer and a larger scope within their neuroscience pipeline) products in the Netherlands. You will be working in close collaboration with the local medical team in addition to global Value & Access teams to develop and execute the local market access strategy. Your key responsibilities in this role encompass leading the preparation of the market to enable a successful launch of new products in the Netherlands by evolving the partnership with payers and other strategic stakeholders. You will manage the patient pathway in the Netherlands and ensure the funding pathway for diagnostic tools, treatment and that monitoring is in place and clearly specified. You are responsible for the preparation of the scientific and economic files for reimbursement. Together with the rest of the team you are responsible for the pricing within the Netherlands. Also you prepare the local player related materials needed for Market Access succes. In the role of Sr. Market Access Manager it is important to have experience within the file preparation regarding the external stakeholders (Zorginstituut, Ministry of Health etc.).

Profile
  • Sc. with a strong preference for the field of Health Economics or Pharmacy
  • +5 years or relevant experience required (in market access, governmental affairs management, public affairs)
  • experience in direct interaction with the external stakeholders (Zorginstituut etc.) and proven track record of access succession is a must have
  • experience in a cross-functional position
  • knowledge of NL healthcare legislation
  • used to travelling, working independently and planning of own time and schedule
  • native Dutch speaker with fluent English skills (verbal, reading and writing)
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/20-040-DD, to Toon Fleminks : info@derksenderks.nl.

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

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.

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.

Sales Manager / Key Account Manager

Offer

  • interesting sales management position combined with key account management
  • global organisation with a focus on long term, sustainable solutions based on science
  • a company with great ambitions and space to develop your team and yourself
  • responsible for commercial team in The Netherlands

Organisation

Our client is a global organisation focused on probiotic skincare. Founded by a scientist passionate about both the skin microbiome and sustainable living, they aim to create effective and sustainable skincare products based on science. Their mission is to redefine global skincare and shift the world’s understanding of and view on skincare. They have a wide range of skincare products and aim to provide long term (sustainable) solutions as opposed to a quick-fix. Currently they are searching a Sales Manager / Key Account Manager for their commercial team in The Netherlands.

Position

As Sales Manager / Key Account Manager you are responsible for the sales and market share development of their wide range of probiotic skincare products in the Netherlands. You are at the start of establishing an independent commercial organization in the Netherlands.

You will build on new relations through different activities and find new collaboration partners and beauty salons to increase the sales. You will ensure a consistent approach towards accounts in line with the company strategy to achieve the commercial goals. In addition, you will lead the current team of 2 sales representatives and offer guidance if needed. You will attend daily sales meetings. You have good communication skills, and understand how to approach different accounts. You understand the sales process, like to build and create leads, and at the same time have the ability to lead a team. You are committed and dedicated to build the brand fast, without compromising on quality. In this job you will report to the General Manager Europe.

Profile

  • Bachelor’s degree or higher (commercial related)
  • at least 2 years of successful experience as a Key Account Manager
  • experience with and examples in strong key account management
  • demonstrated leadership skills is a strong preference
  • affinity or experience with beauty salons is a strong preference
  • ability to translate agreed strategy into an operational action plan with clear timelines
  • fluent use of Microsoft Office, Excel, PowerPoint and Outlook
  • representative, committed, proactive, dedicated, commercial, solution-oriented, strong leadership skills
  • fluent in both Dutch and English

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WS/20-041-DD, to Jamie van der Heijde : info@derksenderks.nl.

For further information, please call Jamie van der Heijde 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.

Apply directly

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.