pharmalex_job_career

We are growing, grow with us!

Want to work in a dynamic company with daily new challenges and opportunities?  Then is PharmaLex your career opportunity.
 
PharmaLex is one of the leading service companies for the global pharmaceutical industry and specializes in all aspects of drugs and medical devices approval of the development to market and any action to product maintenance make it as effective as possible.
The success of our company grows with the excellent expertise and the high motivation of our employees.
If for you, your profession is not only a job but a mission too and you enjoy working with people, then you are welcomed to come and join us.
To strengthen our successful team, we are looking, as earliest as possible for a:

Senior Manager / Associate Director / Director, Clinical and Regulatory Affairs

Your Job

The successful candidate will devise and review clinical development programs and advise from a clinical regulatory perspective on the optimum strategies to satisfy international Agencies’ requirements.

The role may include
 
  • Writing/review of Investigators’ Brochures (IBs)
  • Clinical protocols/synopses
  • Drafting clinical questions positions for scientific advice (protocol assistance) procedures
  • Preparing clinical content for other regulatory submissions (e.g. PIPs, applications for orphan designation, IMPDs, Clinical Overviews/Summaries)
  • Supporting clinical trial authorisation submissions (NCA and EC)
  • General project strategy review and guidance
  • Gap analyses and due diligence

We offer you

  • Diversified and challenging job
  • Cooperating partnership and leeway
  • Flexible working hours based on trust
  • Continuous development opportunities through knowledge and experience as well as training

Your Profile

  • A Biology/Biochemistry/Pharmacology or other Life Sciences degree.  A higher degree (e.g. MSc, PhD, MD) is preferred
  • An understanding of the clinical development pathway across Phases I-III and post-marketing studies
  • Established experience in the development and review of IBs and clinical protocols/synopses
  • Well-honed literature searching and medical writing skills
  • Experience with both small molecules and biological products
  • Experience with at least three of the following: monoclonal antibodies, other recombinant proteins, vaccines, tissue, cell and gene therapies and biosimilars
  • Experience in autoimmune conditions, oncology and metabolic disorders
  • Knowledge and/or experience of adaptive trial design and pathways.
  • Experience in drafting clinical questions and positions for scientific advice procedures
  • Experience in preparing clinical content (e.g. Modules 2.5/2.7) for EU regulatory submissions
  • Experience in clinical and regulatory affairs for the EU, US and other regions of the world