Medical Expert in Hannover bei Serum Life Science Europe GmbH

Are you a medical doctor and already have professional experience in clinical development?

If you would like to further your career in a consulting environment within the pharmaceutical industry, then you have come to the right place!

SLS Europe is a development consulting firm for the biopharmaceutical industry. The main shareholder is Serum Institute of India Pvt. Ltd., the world’s largest vaccine manufacturer. Originally founded to promote vaccine research in Germany, SLS Europe now offers consulting and services for the entire product development value chain for all kinds of medications.

We live product development – transforming ground-breaking ideas into life-saving medication.

To support our clinical project management team we are looking for a

MEDICAL EXPERT (m/f/d)

to join us at the earliest opportunity (full time employment).

• Medical consulting and assistance in the preparation of study documents such as Investigator’s
  Brochure, Clinical Trial Protocol, as well as Paediatric Investigation Plan
• Implementation of clinical development plans and strategies
• Response to clinical deficiency letters as part of the drug approvals process
• Clinical input to and/or authoring and compilation of clinical documentation, including
  • Common Technical Dossier (CTD) for medicinal products
  • Risk Management Plans, Risk Assessments
• Interaction with key opinion leaders/experts in relevant development areas
• Request and review of study-relevant information and medical correspondence
• Evaluation and follow-up of adverse events and ICSRs in accordance with GCP and GVP guidelines
• Support in the preparation of standard operating procedures in collaboration with clinical project
  managers and safety managers
• Performance of all activities in accordance with Good Practice (GxP), national and European laws
  and internal company quality standards

• University degree in Medicine, ideally with a doctorate
• Experience in clinical research, e.g., as investigator or in the field of post-licensure
  pharmacovigilance
• Solid knowledge of ICH-GCP, as well as the applicable legal regulations in the European and
  German environment
• Ability to work in a team and enjoy working in cross-functional project groups
• Willingness to travel
• Very good communication skills, also in an intercultural environment
• Excellent written and spoken English and German language skills
• Professional working knowledge of common software packages (e.g. Microsoft Office, MS Project,
  MedDRA, WHO DD)

• Contribute to our mission to provide life-saving and affordable medication globally
• Manage cutting-edge and challenging national and international projects in pharmaceutical
  development of vaccines, biologicals and other medicinal products
• Become part of a diverse, international, experienced and highly motivated team that values
  common goals and a supportive working environment
• Benefit from our extensive on-boarding process with targeted training and support through
  personal mentoring
• Develop yourself and your career within the company with external and internal trainings

Serum Life Science Europe GmbH
Dr. Leander Grode, CEO
Ahrensburgerstr Str. 1
30659 Hannover
+49 (511) 1699080
application@sls-eu.com