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• Dr. Jörg Dobers

Personal information

• Haves

  Edit Experience in the management of the Medical Writing part of global submissions (EMA, FDA, Japan) and the respective authority responses - outsourcing of projects to CROs and freelancers including contract management - scientific and regulatory writing - management and mentoring of Medical Writing staff. Proficiency in the following document types: Module 2.7.3 (Summary of Clinical Efficacy), Module 2.7.4 (Summary of Clinical Safety), Module 2.5 (Clincial Overview), study protocol, clinical study report, briefing book, risk managment plan, SmPC, periodic safety update report, paediatric investigational plan. Therapeutic areas: macular degeneration, oncology, pulmonary hypertension, oral contraception, multiple sclerosis, COPD/asthma, vaccines, dermatology, diabetes, HIV, hepatitis, molecular diagnostics, contrast media, haemophilia, thrombosis prophylaxis, submental fat etc.

• Interests

  Edit Langstreckenlauf, Reiten, Südamerika (Reisen und Kultur), Modellbau, Stromgitarre

• Organizations

  Edit European Medical Writers Association (EMWA), Drug Information Association (DIA)

• Groups

  

Educational background

• Languages

  German (First language), English (Fluent), Spanish (Basic knowledge), French (Basic knowledge)