vacature klinisch-onderzoek

Digital Clinical Data Manager

Offer
  • a challenging job within a global healthcare company
  • an operational role in an international environment
  • a temporary contract till the beginning of December
Organisation

Our relation is international active in the healthcare industry. They produce and sell their products to the international market. They are always looking for new innovative medical device products by investing in research and development. With this investment they hope to stay on top of the market. They design the product trough the eyes of the end user combined with an appealing design. The organisation is always looking for improvement of there processes. Therefore, they like to get in touch with a Clinical Data Manager.

Position

The organisation is a new business within the venture organization. The venture is tasked with developing a new “software only” product called IntelliSpace Cognition. This new product is a class II medical device. In the position of Digital Clinical Data Manager, you will conduct source data verification by checking data for accuracy and completeness. You will optimize the collaboration between data owners and domain experts. Furthermore, you are exporting and organizing data from our product database and developing a long-term data management strategy. Reviewing and cleaning research data will also be a task in the position. You will also prepare data files for analysis in close contact with other team members and provide insightful data overviews for clinicians, researchers and software developers. Next to this you will create interfaces and dashboards to gain deeper insights into the performance of the products. In the position you will report to the manager of the department.

Profile
  • work experience or degree that supports clinical data management
  • a “go do”, self-propelling attitude to work
  • ability to interact with people in both the scientific, clinical and technical (SW) worlds
  • affinity to work with clinical data and ability to develop software independently
  • solid knowledge of at least one programming language (R or Python preferred)
  • knowledge of Postgres databases is a plus
  • knowledge of Good Clinical Practice
  • accurate and an eye for detail
  • good written and verbal English skills
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-124-DD, to Sandra van Putten: info@derksenderks.nl.
For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.

vacature kwaliteit

Quality Manager

Offer
  • working in an international environment
  • dynamic and challenging role
  • good secundaire benefits
Organisation

Our client is a supplier of high-quality medical products. They specialise in products for wound, continence, diabetes and acute (first aid) care. They offer a wide range of brands, including their own. These products have been developed on the basis of the latest insights and developments in healthcare. They are a dynamic and fast-growing company with 50+ employees. Our client has an open, informal culture with short lines of communication. Hard work go hand in hand with solidarity and a pleasant working atmosphere. This position is based in Venray.

Position

As a Quality Manager you will work in close cooperation with all departments in the company and with our client suppliers and distributors. In this role you will be responsible to guarantee the quality policy of the company. You will ensure that this policy is understood, implemented and maintained at all levels of the organisation while complying with the applicable regulatory requirements. Besides this you will assess the regulatory requirements for new products, define the regulatory strategy, manage regulatory submissions and obtain approvals in a timely manner. Other tasks may include setting up and coordinating supplier improvement quality performance programs and performing audits and providing audit support both internally and with suppliers and distributors. As a Quality Manager you will report to management on the implementation and effectiveness of the quality management system and identify needs for improvement. Besides this you will prepare and maintain clinical evaluations and post market surveillance reports.

Profile
  • bachelor’s or master’s degree in life science or engineering area
  • preferably minimum of 5 years’ experience in EU regulations/ standards related to wound, continence, diabetes and acute (first aid) care
  • experience leading and facilitating audits
  • results and customer oriented, rigorous, autonomous and flexible
  • knowledge and experience of medical devices, MDR and ISO 13485
  • strong oral and written communication in Dutch and English
  • great organisational skills and a ‘getting things done’ attitude
  • self-learner
  • preferably located in Venray (NL) area
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-063-DD, to Djamila Hagemans : info@derksenderks.nl.

For further information, please call Djamila Hagemans 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.

vacature techniek

Project Data Manager

Offer
  • a position to grow into or to deliver out of your experience
  • responsible for the supply chain business flows at an international project
  • a fulltime contract of 1 year, possibly longer
  • possibility to work from home or from the location in South Netherlands
  • project contract from Derks & Derks Secondment & Interim
Organisation

Our client is an international pharmaceutical company. The company’s activities comprise the development, production and sales of medicines. For the facility in Drenthe we would like to meet an enthusiastic, communicatively skilled, self-assured and performance-oriented Project Data Manager. 

Position

As a Project Data Manager you will be involved in the serialization project. The organisation uses a could bases solution to follow the products. For the products is it mandatory in many countries and the list of countries for Serialization is growing. Serialization follows strict rules prescribed by the Regulatory Authority of the Country of Sales.

The Project Data Manager will be responsible to ensure that proper data management is applied in the governance processes and data life cycle maintenance processes. You will be the pivotal point for conceptual developments and implementation of future Serialization requirements. A part of your role will be actively participating in various global Serialization initiatives, provide global perspective in Serialization decisions, data governance and management processes. The role is global in nature, collaborating with stakeholders (on business decision making level) in all regions and delivering on cross-regional responsibilities. The organisation is interested in a candidate that holds a natural interest in data governance where data standards, rules, ownership, quality, maintenance techniques, documentation and education need to be of the highest standard. You need to have a proactive attitude in knowledge collecting and sharing as well as communication. In line with this, business travel is required. Your reporting line will be to the Manager Master Data.

Profile
  • at least a bachelor’s degree or higher education in a relevant field
  • 5+ years of experience in a data management and or project management role, preferably within supply chain & manufacturing in the pharmaceutical industry
  • 3+ years of experience in coaching or managing staff
  • cemonstrated project management competences
  • prior contact with Serialization requirements would be considered a advantage
  • hands-on SAP experience gained in the Supply Chain and Master Data domain
  • ability to develop a vision to meet overall long term strategy
  • ability to work in a dynamic, volatile business environment
  • result-oriented, a key organizer and planner who clearly sets priorities
  • ability to work under pressure and manage a variable workload for the team
  • basic knowledge of GMP is preferable
  • good communication skills in the Dutch and English language
Response

Interested? Please send your resume and motivational letter by e-mail, with reference number DT/19-115-DD to Office@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.

 

vacature kwaliteit

Quality Engineer

Offer
  • working in an international environment
  • dynamic and challenging role
  • good secundaire benefits
Organisation

Our client is a supplier of high-quality medical products. They specialise in products for wound, continence, diabetes and acute (first aid) care. They offer a wide range of brands, including their own. These products have been developed on the basis of the latest insights and developments in healthcare. They are a dynamic and fast-growing company with 50+ employees. Our client has an open, informal culture with short lines of communication. Hard work go hand in hand with solidarity and a pleasant working atmosphere. This position is based in Venray.

Position

As a Quality Engineer you will be part of the Quality Department and report to the Quality Manager. You work closely together with the Product Managers. You will be responsible for the preparation and maintenance of the technical files in support of CE marking of existing and new medical devices. Besides this you will assess the production methods and quality processes at suppliers and distributors. You will make root cause analyses through quality data analysis and failure analysis process and implement the corrective and preventive actions. Other tasks may include performing internal and external audits of products and (production)processes and executing the post market surveillance plan. Besides this you will demonstrate compliance of the quality processes during audits and inspections by our clients Notified Body, customers and regulatory authorities.

Profile
  • bachelor or master with minimum 3 years’ experience
  • experience with the medical device sector in wound, continence, diabetes and acute (first aid) care is a plus
  • trained and knowledge of process and product audits
  • experience with ISO13485 and medical devices regulation
  • good analytical and logic deduction skills, problem solver
  • good communication and negotiation skills
  • strong oral and written communication in Dutch and English
  • preferably located in Venray (NL) area
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-064-DD, to Djamila Hagemans: info@derksenderks.nl.

For further information, please call Djamila Hagemans 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.

 

 

vacature techniek

Product Data Manager/ Master Data

Offer
  • a position where your experience is recognized
  • working in international projects
  • a contract for at least one year
  • changes to growth is your knowledge
  • flexibility to work from different locations and from home
Organisation

Our client is an international pharmaceutical company. The company’s activities comprise the development, production and sales of medicines. They have several locations in The Netherlands where they looking to hire a new team member for the facility in Drenthe or Zuid-Holland. They would like to meet an enthusiastic, communicatively skilled, self-assured and performance-oriented Product Data Manager/Master Data.

Position

As a Product Data Manager/Master data you work together with a team. The team is responsible to provide and maintain high quality compliant master data that are available on time, in a consistent and controlled way. Thus, facilitating smooth execution of operational Supply Chain processes across the EMEA region. To own the Supply Chain Business Flows in EMEA SAP, you organize and manage the creation and maintenance of material master and master data aspects according the business scenarios and business rules. You also create and maintain material master data to support changes in existing business and introduction of new products and materials. You lead or participate in various projects where master data creation or change is involved. Due to various medium and large sized projects you create, update or delete material master data records. Additionally, some processes need to be changed. All the changes in processes and master data need to be documented by you. You will report to the Manager Master Data based in The Netherlands.

Profile
  • at least a bachelor’s degree or higher education in a relevant field
  • over 3 years of experience with Product Data Management or Master Data management
  • experience as (key) user of SAP
  • basic knowledge of GMP is a nice to have
  • profound knowledge of supply chain and manufacturing processes
  • good writing skills in English
  • good communication skills in English language
  • flexibility to work from several locations
Response

Interested? Please send your resume and motivational letter by email, with reference number DT/19-135-DD to Office@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 B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

vacature overig

Technical Writer Master Data

Offer
  • a position to grow into or to deliver out of your experience
  • responsible for the supply chain business flows at an international project
  • a fulltime contract of 1 year, possibly longer
  • possibility to work from several locations
  • temporary contract from Derks & Derks Secondment & Interim
Organisation

Our client is an international pharmaceutical company. The company’s activities comprise the development, production and sales of medicines. For the facility in Drenthe we would like to meet an enthusiastic, communicatively skilled, self-assured and performance-oriented Technical Writer Master Data.

Position

As a Technical Writer, you will be added to the master data team. The team is growing from a regional team into a global team. The current set of documentation requires to be rebuilt and made fit-for-purpose to the new ERP software solutions that are to be introduced over the next years.

As a Technical Writer, you will support the convert of the existing documentation supplemented with collected expert knowledge (through interviews) and available technical documentation in system user (e)-documentation such as procedures, instructions and training material. You will collaborate with the master data team to get a good understanding for their work processes and translate this into useful content for end users. You ensure output is consistent across product families and output formats. All together this is a challenging job where you can grow your knowledge of the Pharma sector with enough freedom to put your own ‘stamp’ on the output. In this job you will report to the manager of the department.

Profile
  • at least a bachelor’s degree or higher education in a relevant field
  • Supply Chain knowledge
  • interviewing skills augmented with user experience review and feedback
  • understanding of software tools used to create software product documentation
  • knowledge w.r.t. Master Data Management is preferred
  • proficient English writing skills
  • good document layout skills
  • basic business process design skills
  • profound Microsoft Office solution knowledge e.g. Word, Visio, PowerPoint,
  • SAP knowledge
  • ability to plan and manage multiple tasks
  • effective time management, good presentation skill and proactive approach
Response

Interested? Please send your resume and motivational letter by e-mail, with reference number DT/19-123-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. An individual assessment may be part of the selection procedure.

vacature regulatory-affairs

Regulatory Affairs Manager

Offer
  • a challenging and fast-growing organisation
  • family culture where everyone makes a collaborative impression
  • a role where you need your knowledge to help the growth
  • great abilities for a personal grow
  • good salary package
Organisation

The organisation is a (bio)pharmaceutical company based in Noord-Brabant. They are currently facing the next stage of the clinical phase where they need to expand their team with another expert. Therefore the organisation is looking forward to get in touch with a flexible and collaborative Regulatory Affairs Manager.

Position

In the position of Regulatory Affairs Manager you will have the basic responsibility to ensure that the organisation has an established, maintained, comprehensive and efficient global regulatory strategy that aligns pharmaceutical product development timelines, product authorisations and budget. Other responsibility will be that you maintain good contacts with global competent authorities and that you will write and maintain IMPD for all products. You will coordinate writing and approval of regulatory required documentation. But you will also coordinate regulatory submissions. Furthermore you will be responsible for review and approval of the rationale and regulatory impact assessment related to any potential (substantial) changes to the product, manufacturing process, analytical methods of our products under the Pharmaceutical Quality System. You will act as the regulatory point of contact for external partners, companies, or organisations for product related regulatory questions. You will inform potential (upcoming) ATMP regulatory or guidance document changes which may impact product development and authorisations. Overall you will be responsible for product approval timelines coordination. Next to this you will also be creating extra awareness for regulatory by sharing your knowledge with others and even train others. In the role you will work closely with the QA/QP manager and the team. You will report to the Director Operations.

Profile
  • at least a bachelor’s degree
  • over 5 years of regulatory experience within ATMP
  • working experience in the industrial (bio)pharmaceuticals
  • ability to implement complex regulatory details in a simple strategy while adhering to relevant regulations
  • good written and oral skills in English
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-073-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 B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Responsible Person

Aanbod
  • maatschappelijk verantwoordelijke functie;
  • schakel tussen farmacie en maatschappij;
  • cultuur van gedreven professionals met erkenning voor expertises;
  • flexibele werkgever met ruime opleidingsmogelijkheden.
Bedrijf

Onze opdrachtgever, het Rijksinstituut voor Volksgezondheid en Milieu (RIVM) zet zich in voor de gezonde mens in een gezonde leefomgeving. Als kennisinstituut van de overheid op het gebied van volksgezondheid, voeding, milieu en veiligheid vervult het RIVM de rol van betrouwbare adviseur (Trusted Advisor). In deze rol ondersteunt het RIVM burgers, professionals en overheden bij de uitdaging onszelf en onze leefomgeving gezond te houden. Het RIVM voert kennisintensieve taken uit, zoals de Bevolkingsonderzoeken en CBRN (Chemische, Biologische, Radiologische, Nucleaire) crises, maar ook landelijke preventie- en screeningsprogramma’s, waaronder het Rijksvaccinatieprogramma (RVP). Voor deze programma’s zijn wij nu op zoek naar een Responsible Person.

Functie

Het RIVM verzorgt de inkoop, opslag en distributie van vaccins en andere geneesmiddelen voor o.a. het RVP en de jaarlijkse griepprik. Samen met een collaga RP ben je verantwoordelijk voor de transportvrijgifte, opslag, transport en beheer van bovengenoemde farmaceutische producten. Je werkzaamheden zijn gevarieerd. Zo kan je het ene moment bezig zijn met het afhandelen van klachten of het beoordelen van kwaliteitsdocumenten. Op een volgend moment wordt er advies gevraagd over de voorraden van de vaccins of het beoordelen van incidenten in de cold chain. Tenslotte ben je dagelijks bezig met het wel of niet vrijgeven van verschillende vaccins. Hierbij ben je niet alleen eindverantwoordelijk voor Nederland, maar voor het hele Koninkrijk. Kortom, geen dag is hetzelfde en vraagt om continue prioritering van werkzaamheden. Er wordt verwacht dat je in staat bent om intern een netwerk op te bouwen met collega’s van logistiek, de verschillende regiokantoren en het management. Daarnaast sta je ook in contact met de RP’s van fabrikanten. Je komt te werken in een omgeving met hoge verantwoordelijkheid en een sterke maatschappelijke betrokkenheid. Als RP heb je zicht op het farmaceutische speelveld en weet dit te verbinden met de wereld van het RIVM. Belangrijke taken die tot je pakket behoren zijn onder andere (maar niet beperkt tot): het controleren van het kwaliteitsmanagementsysteem voor de vaccinvoorziening door audits en het trainen van medewerkers in (gewijzigde) processen; het verzekeren van correcte klachtafhandeling; besluiten nemen over retour gekomen, afgekeurde, teruggeroepen of vervalste producten; het adviseren over vaccins bij cold chain incidenten en tot slot ook participeren in GDP-audits bij leveranciers, en het coördineren van recall activiteiten.

Profiel
  • minimaal afgeronde hbo/wo opleiding in de richting van Farmacie of gelijkwaardig;
  • enige jaren werkervaring als RP of een gelijkwaardige functie binnen QA in de farmacie;
  • je hebt ruime kennis van en ervaring met werken binnen de GDP en andere relevante regelgeving;
  • kennis van GAMP-5 is gewenst;
  • je bent bereid buiten kantoortijden bereikbaar te zijn;
  • je bent in staat een intern en extern netwerk op te bouwen;
  • je bent flexibel, pragmatisch, stressbestendig, gedreven, creatief en kan prioriteren;
  • je hebt uitstekende communicatieve vaardigheden zowel mondeling als schriftelijk in Nederlands en Engels.
Reactie

Geïnteresseerd? Stuur je curriculum vitae en motivatie, onder vermelding van referentienummer WS/19-045-DD, naar Toon Fleminks, info@derksenderks.nl.

Voor meer informatie kun je bellen met Toon Fleminks 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/uw 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 klinisch-onderzoek

Consultant Clinical Development

Offer
  • a challenging job within a Dutch Life Science consultancy
  • contribute to the development of pharmaceuticals and diagnostics
  • good secondary benefits
Organisation

Our client is a Dutch Life Sciences consultancy and operational support firm, located in Tilburg and Oss. The company is dedicated to the development of pharmaceuticals and diagnostics. Their clients are leading pharma companies as well as innovative biotech start-ups. For the various projects that they are running for their clients, they are looking for a Consultant Clinical Development.

 Position

As a Consultant Clinical Development you will be responsible for the development of clinical strategy and clinical operations of (bio)pharmaceutical compounds. You will be involved in drafting clinical development plans of clinical trials and documentation for regulatory submission.
You are responsible for the clinical development strategy of an investigational compound, including the definition of milestones and Go/NoGo criteria. In this role you need to be able to translate biomarker data to decisive proof-of-concept studies. Besides this you are responsible for the design, execution and reporting of clinical trials according to timelines and within budget, and writing essential documents e.g. Clinical Trial Protocol, IB etc. As a Consultant Clinical Development you are a representative in Scientific Advice meetings at regulatory authorities (EMA, FDA), but also in a cross functional collaborative environment. You are an equal and expert discussion partner in the communication with KOL’s. Other tasks may include managing external partners and/or service providers, guiding operational clinical activities and coordinating project management activities to ensure timely, uniform and quality delivery of the services provided to our clients.

Profile
  • relevant academic background in biomedical field, preferably PhD
  • experience with (early) clinical drug development
  • a minimum of 5 years’ experience in the biotech or pharmaceutical industry
  • evidence of good scientific and clinical judgment, flexibility, and resilience
  • up-to-date knowledge of legislation and regulations and ICH-GCP guidelines
  • experience with Scientific Advice meetings at EMA or FDA is a pre
  • strong sense of meeting milestones, timelines & budgets
  • excellent communication and presentation skills
  • capable of effectively managing multiple deadlines and projects
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-071-DD, to Djamila Hagemans : info@derksenderks.nl.

For further information, please call Djamila Hagemans 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.

vacature kwaliteit

QP Biotechnology

Offer

  • an innovative, fast growing, biotechnology company
  • a role where your knowlegde is welcome
  • a permanent contract, starting with a 5 months contract

Organisation

The organisation is a Biotechnology company focused on cellular Immunotherapy in clinical stages. Recently they develop a new method to make cancer a chronic disease and they can use some help. Our client is located in The Netherlands and has about 50 employees that think globally. They are ambitious and believe in their product. To expand their team they are looking for someone like them, always striving for the best. Currently they are looking for an Interim QP.

Position

As Interim QP your role entails a broad range of duties and the specific areas of focus will be dependent on the skills and experience of the person holding the role. The basic responsibility is to ensure that our cell and gene therapy products are manufactured and released according to quality guidelines, regulatory requirements and trial needs. You provide guidance and direction to Development, Production and Quality staff regarding compliance with quality standards and procedures.

You will be responsible for ensuring that each individual batch has been manufactured and tested in accordance with the requirements of the IMPD and the applicable GMP regulations. Also you are responsible for batch disposition (e.g. GMP-release) of the batches produced. You are involved in the set-up and validation of the manufacturing process, analytical methods and specifications. In addition to the QP role and responsibility the QP will help and assist with Document control, Deviation and CAPA system management but also Product complaints, returns, and recalls. Furthermore you give the Vendor approval, qualification and management and make round regarding the Internal (self-inspections) / external audit program. In this role you will report to the Chief Regulatory/Quality Officer with the obligatory dotted line into the CEO.

Profile

  • Sc. or PhD degree in pharmacy, biotechnology, biology or equivalent
  • experience in QP-related functions
  • experience working in a GMP regulated environment
  • experienced in biotech products where experience with Advanced Therapy Medicinal Products (ATMPs) is preferential
  • knowledge of biotech production processes
  • knowledge of sterile production processes
  • knowledge of GMP quality systems

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-111-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.