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Regulatory CMC Guideline Specialist |
Farmaceut | Oss | september 2010 | For a pharmaceutical company, we are seeking for 1 Regulatory CMC Guideline Specialist / Region Specialist (32-40 uur) for the department of Network CMC (Chemistry Manufacturing & Control) in Oss, the Netherlands.
The Regulatory CMC Guideline Specialist supports the Product Specialists by keeping track of the local regulatory requirements worldwide and update the database with this new information.
The Network CMC team is responsible to carry out regulatory activities that are needed in the context of site changes, in particular with respect to chemical/pharmaceutical aspects of the submissions. Network CMC is part of Quality Assurance and Pharmaceutical CMC.
The position will start with a 12 months contract, but as the project is expected to be continued, it is very likely that the contract may be extended for a period of about 3 to 4 years.
Tasks and Responsibilities:
• The Network CMC point of contact and centre of knowledge with respect to global Health Authority dossier requirements. Advices on filing strategies for Network CMC derived submissions.
• Is the centre of knowledge in Network CMC with respect to regulatory requirements and Health Authority expectations for CMC submissions and corresponding submission procedures
• Collects Intelligence based on multiple sources ( info from local RA representatives, existing and new guidelines, Health Authority responses on earlier submissions) and provides interpretation and practical consequences.
• Maintains a regulatory CMC requirements database with key data on dossier content and submission procedures per country/region. Adapts the database as needed, based amongst others on Health Authority feedback and new legislation.
• Advices in and outside Network CMC about interpretation of guidelines and provides best practices for dossier content and and submission strategy
• Actively supports initiatives on harmonization and standardization of dossiercontent
• Represents Network CMC in (ad hoc) teams with respect to filing strategies.
• Supports the Product Specialists by collecting certain dossier elements ( samples, CofA’s, legalized certificates)
• Advices Network CMC Planner on official Health Authority review and approval times
• Contacts local RA representatives and advices on planned submissions
• Coordinates Network CMC comments on new guidelines.
• May represent Network CMC in meetings with Health Authorities
Requirements:
- At minimum a bachelor degree.
- Minimum of 3 years experience in Pharmaceutical CMC or Regulatory Affairs.
- Good command of written and spoken English.
- Command of Dutch language is an advantage, but no must
- Good editing skills.
- Has good social skills and is a good team player.
- Able to work on an independent base.
- Communicative and persuasive person
- Good organizational skills |
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Inhouse CRA |
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Farmaceut | Flevoland | september 2010 | Voor één van onze opdrachtgevers zijn wij op zoek naar een ervaren CRA voor een inhouse functie. Minimaal 2 jaar ervaring is vereist, de voorkeur gaat uit naar kandidaten met meer ervaring. |
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Senior CRA |
CRO | Zuid-Limburg | september 2010 | Functie omschrijving:
Als CRA initieert, begeleidt en coördineert u, uit naam van een opdrachtgever, een klinisch onderzoek. Uw rol is een centrale, cruciale rol aangezien u de coördinator bent van het gehele logistieke onderzoeksproces. Het betreft hier fase 1 t/m 4 onderzoeken. Deze onderzoeken vinden zowel in centra binnen Nederland alsook in het buitenland plaats. Hierdoor zult u bereidt moeten zijn om frequent te reizen (circa 50%). U maakt deel uit van een team van 7 CRA’s en u rapporteert rechtstreeks aan de CEO. Succes hebben in deze functie heeft alles te maken met communicatie, kennis, het opbouwen en onderhouden van relaties, probleemoplossend vermogen en het winnen van vertrouwen. Er is bijna geen bedrijfstak te bedenken waar u zoveel zelfstandigheid en vrijheid kunt combineren met de mogelijkheid al uw talenten tot het maximale te ontwikkelen. U bent communicatief sterk, stressbestendig en heeft een hoge mate van flexibiliteit.
Taken en verantwoordelijkheden
Het initiëren, coördineren en begeleiden van het onderzoek.
Het genereren van gegevens voortvloeiend uit het gebruik van een nieuwe medische toepassing.
Het verzamelen, controleren en rapporteren van deze gegevens.
Het verwerken van deze gegevens in documenten bedoeld voor METC’s (Medisch Ethische Commissies)
Het bezoeken van medische centra ( bijvoorbeeld ziekenhuizen of onderzoeksbureaus), en het initiëren, coördineren en onderhouden van contacten met opdrachtgevers en alle relevante partijen ( o.a. researchers, artsen, functieafdelingen, laboratoria, METC’s) met betrekking tot het onderzoeksproces
Functie eisen:
• Relevante (bio)medische opleiding op HBO- of WO- niveau
• Relevante ervaring als CRA is een absolute must
• Affiniteit met (medisch-gerelateerd) onderzoek en procedures/richtlijnen (GCP en ISO 14155) hieromtrent
• Kennis van gangbare computerapplicaties (Word, Excel, Powerpoint)
• Goede schriftelijke en communicatieve vaardigheden in Nederlands, Engels en Duits
Persoonskenmerken:
• Communicatief vaardig en resultaatgericht
• Servicegericht
• Dynamische en flexibele teamspeler
• Stressbestendig
• Leergierig en gemakkelijk in de omgang
• Bereidheid minimaal 50% van de tijd te reizen (internationaal en nationaal)
Kandidaat dient woonachtig te zijn in de omgeving van Maastricht/Luik/Aken |
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Ervaren Clinical Research Associate (CRA) |
TFS Contract Placement Solutions | Nederland, België, Frankrijk en/of Duitsland | doorlopend | TFS Contract Placement Solutions houdt zich bezig met detachering, training en werving & selectie. In verband met een sterke uitbreiding van onze activiteiten in Nederland, België, Frankrijk en Duitsland zijn wij op zoek naar ervaren CRA's.
Heb jij een afgeronde biomedische of (para)medische opleiding op HBO of WO niveau en ben je fulltime beschikbaar, dan willen wij graag met jou in contact komen. Wij bieden de mogelijkheid om door te groeien naar een vaste baan met aantrekkelijke primaire en secundaire arbeidsvoorwaarden en goede opleidings- en doogroeimogelijkheden. Werken bij ons betekent werken in een middelgrote organisatie, met de voordelen van een grote, internationale organisatie! |
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CRA (PM) met veel oncologie ervaring |
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Farmaceut | Randstad | september 2010 | Voor één van onze opdrachtgevers zijn wij op zoek naar een ervaren CRA (PM) met veel oncologie ervaring. |
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Regulatory CMC Specialist |
Farmaceut | Oss | september 2010 | For a pharmaceutical company, we are seeking for 2 Regulatory CMC Specialists / Product Specialists (32-40 hours) for the department of Network CMC (Chemistry Manufacturing & Control in Oss, the Netherlands.
The Network CMC team is responsible to carry out regulatory activities that are needed in the context of site changes, in particular with respect to chemical/pharmaceutical aspects of the submissions. Network CMC is part of Quality Assurance and Pharmaceutical CMC.
The position will start with a 12 months contract, but as the project is expected to be continued, it is very likely that the contract may be extended for a period of about 3 to 4 years.
Tasks and Responsibilities:
- Prepares CMC documentation for international submissions in accordance with local dossier requirements.
- Takes part in the review and release of CMC documents in accordance with the applicable procedures.
- Supervises the compilation of CMC dossiers.
- Answers questions from health authorities and coordinates the Agency Response process.
- Is conversant with relevant, worldwide registration requirements.
- Is conversant with literature relevant to the projects and products assigned to him/her.
- Makes proposals to the organization with regard to variations of chemical/pharmaceutical documents following questions from authorities. Consults wit the departments involved.
- Takes the initiative for and coordinates additional studies which are performed by the chemical/pharmaceutical disciplines.
- Has contacts with other MSD staff of local companies and other sister companies.
- Sees to planning, coordination and implementation of all the tasks related to his/her project.
Requirements:
- MSc (Chemistry, Physics, Pharmacy, Analytical Chemistry) or BSc with multiple years of experience
- Minimum of 2 year registration experience in CMC.
- Good command of written and spoken English.
- Command of Dutch language is an advantage, but no must
- Good editing skills.
- Has good social skills and is a good team player.
- Communicative, assertive and persuasive person
- Good organizational skills |
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Regulatory Affairs Officer |
Farmaceut | Houten/Haarlem | oktober 2010 | You will work in Houten till the end of 2010 and from the beginning of 2011 in Haarlem.
Goal of the department:
Deliver on all aspects of Regulatory Affairs strategy and operations for the Netherlands, including developing and implementing the regulatory strategy and ensuring compliance with applicable laws, policies, and operating procedures in that country/countries.
Position Description Summary:
The Regulatory Affairs Officer is, together with the Head of Regulatory Affairs, the primary liaison representative for the company with the local competent authorities, and must ensure:
· the adequacy of all submitted documentation with respect to regulatory requirements for registration;
· ongoing compliance with the conditions of the (maintenance of the) marketing authorizations;
· execution of the above responsibilities in an ethically sound manner at all times.
Tasks and responsibilities:
The main areas of responsibility include:
1. Support and documentation for a range of registered products;
2. Promotional Materials review;
3. Regulatory Support for Clinical Studies;
4. Communication, negotiation and advisory role.
KEY RESULTS AREAS :
In-line product support
Life-cycle maintenance of approved products
- Maintain registration data updated
- Participation in the PSURs with local Medical Dept (Drug Safety Officer) and head quarters
Review and approval of labelling changes
- Close cooperation with Global and EU Regulatory Affairs, involving other departments as needed
Review and approval of product information translations
- Close cooperation with Global and EU Regulatory Affairs, involving other departments as needed
Handling of license transfers and renewals
Inspection follow-up
Participation in Product Recall Procedures
A Regulatory Affairs Officer should be capable to handle all above tasks independently and should be capable to Chair Product Recall procedures.
Promotional material review and approval
Regulatory Support for Clinical Studies
In line with the European Clinical Trial Directive, and its implementation in local law in the Netherlands, provide all required support to studies in the Netherlands (registration and non-registration studies), involving Global Regulatory Affairs as needed. This requires good planning and close collaboration with Medical Affairs and Clinical Research colleagues.
Communication, negotiation and advisory role
At the local level, the Regulatory Affairs Officer together with the Head of Regulatory Affairs has a central role as the company representative with the competent authorities, and as such, must be seen as an informed and credible spokesperson. With the new EU procedures, the local RA Officer should possess and maintain a thorough understanding of the EU procedures, together with a sound understanding of the culture and workings of the local authorities. He/she also should possess an understanding of the review status of an application or any other potentially important matter locally and other member states.
Job Requirements:
· Pharmacist, Physician, Biochemistry or university degree, Regulatory experience is a plus
· Pharmacist, Physician, Biochemistry HBO degree and at least 5 years experience in a relevant Regulatory Affairs function
· Knowledge of Marketing Authorisation guidelines including variations.
· Knowledge of Clinical Trial Directive
· Knowledge of the Dutch Drug Act including the Code of Conduct on Drug Advertising
· Understand the roles and responsibilities within the SP NL departments and within Global Regulatory Affairs
· Must be well organized, accurate, structured, autonomous and accountable
· Ability to work under strict timelines: strong planning skills, combined with flexibility when emergency situations require this
· Interpersonal relations skills, and negotiation skills. Ability to establish contacts rapidly
· Fluency English and Dutch (both orally and in writing)
· Proficient in common computer programs (Microsoft office, Access) and able to assess new technological tools to improve work efficiency
· Cross functional team working, collaboration, listening and learning
· Business integrity, benchmark and continuously improve
· Shared accountability and transparency
· Coaching and Developing Others |
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