Company: Hydrogen Group
Closing Date: 01 Nov 16
Salary (£): Negotiable
Medical Expert- Immediate Start- UK, France or Switzerland Level: Medical Expert (MD) Salary: Negotiable Location: EU-UK, France, Switzerland Summary We are looking for a Medical Expert to join a leading pharmaceutical company. The successful candidate will have a paramedical background with a strong understanding of Clinical research and development process. ...
Medical Expert- Immediate Start- UK, France or Switzerland
Level: Medical Expert (MD)
Location: EU-UK, France, Switzerland
We are looking for a Medical Expert to join a leading pharmaceutical company. The successful candidate will have a paramedical background with a strong understanding of Clinical research and development process. The details are as follows:
* Medical Doctor with non-clinical and clinical experience with expertise in therapeutic of Neurology/CNS and biologics
* Responsible for providing advice on projects involving the design of clinical development plans, clinical aspects of Scientific Advice Procedures and Marketing Authorisation Applications, clinical trial protocols, Health Technology Assessment submissions, Orphan drug designations, Risk Management Plans, Paediatric Investigation Plans and Compassionate Use Programs
* Experience working with regulatory agencies such as FDA, EMA, and local regulatory agencies
* Experience interacting with the CHMP, and providing expert advice regarding interactions with regulatory agencies
* Extensive experience with centralised, mutual recognition and decentralised procedures with experience leading clinical assessment of marketing authorisation, type II variation and line extension applications for a variety of medicinal products
* Experience authoring several CHMP and MHRA reports including product assessment, inspection, similarity and new active substance assessment reports
* Experience negotiating with European regulators on content of key regulatory documents, including product information documents and European product assessment reports (EPAR).
* Specific expertise in clinical development of biotechnology products including monoclonal antibodies, antibody-drug conjugates, ATMPs (stem cell, somatic cell and gene therapies), enzymes, hormones, blood products, growth and colony stimulating factors and their antagonists and ancillary medicinal substances
* Experience reviewing and carrying out gap analysis for existing products
* Minimum 10 years in the Medical field (previous experience in the clinical and pharmaceutical industry required)
* Degree in relevant Medical Subject (Doctor of Medicine)
* Scientific and ethical integrity
* Solid knowledge in clinical development of drugs and biological products
* Experience with Neurology and CNS
* Strong experience interacting with Regulatory agencies and experience working with orphan drugs
This is a permanent contract please make an application or contact:
30 Eastcheap London
|Tel:||+44 (0) 207 002 0000|
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