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   Offres d'emploi GALDERMA

GALDERMA is one of the Pharmaceutical leaders in Dermatology. GALDERMA provides dermatology solutions and aesthetic and corrective products internationally. The company has 33 wholly-owned affiliates and a worldwide network of distributors, 5 000 employees and an extensive product portfolio available in 80 countries. We are seeking for our R&D Centers in France (Sophia Antipolis) or Sweden (Uppsala):


Permanent position

Within the Scientific Division Global Regulatory Affairs Department and Global Regulatory Operations (GRO) Group, you will be in charge of the production of regulatory documents for international filings (US, EU, CAN, JPN,) for Prescription products, Medical Devices or Biologics and support to clinical programs. Your main missions:
  • As member of the Global Project teams, represent as Global Regulatory Operations Project Team Representative the expertise of GRO and more specifically scientific writing, and to apply project management methods to document production.
  • To propose document production strategies and select and recommend external writing partners (outside contractors) to management, as needed.
  • For Prescription products, Medical Devices or Biologics, to produce multidisciplinary documents covering Clinical, Quality and Non Clinical information such as Investigators Brochures, Briefing Packages, Pediatric plans (PSP and PIP), IND/IDE, IMPD, NDA/PMA/BLA, Responses to authorities but also Clinical Study Reports (Phases 1 to 3), according to Projects defined timelines and Galderma quality standard:
    - Ensure early and consistent message and format definition, careful planning, and overall management of the document production process, in collaboration with other internal and external experts when applicable.
    - Collect, analyze, interpret and synthesize all relevant
    source information
    - Write up and/or coordinate internal or external
    documents production
    - Ensure that key messages and critical issues are
    accurately and consistently addressed across documents.
    - Manage review, approval and release of each document, through proper liaison with peers and other experts in various R&D departments and Galderma sites.
  • To contribute to GRO insurance and update SOPs, to interface process fine-tuning with other departments, to participate in the global standardization of processes (e.g. through involvement in task-forces or dedicated working groups).
Candidate profile :

You have a Bachelor of Science, Master, Pharmacy, Doctoral or equivalent. You have more than seven years of work experience within industry R&D (Pharmaceutical, Cosmetics, Medical Device and/or Biologics) among which at least five years in similar position. Fluent English with strong written skills.

Position based in one of the Galderma R&D centers in Europe in France (Sophia Antipolis) or Sweden (Uppsala). Open position, salary to be defined regarding experience & profile.

If you are interested in this position, we thank you to send your application, referenced SA/SW0515/GRD by email to: candidature@pharmanetwork.com

GALDERMA, DRH - Les Templiers - 2400, route des Colles - Sophia Antipolis, 06410 Biot

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