pharmalex_job_career

We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

 

Senior Specialist/ Assistant Manager - Development Consulting & Scientific Affairs


Your Job

  • Thorough knowledge of EMA and FDA regulatory guidelines

  • Excellent skills in literature search

  • Preparation of protocol, clinical study report, and other study related documents

  • Manuscript writing, Systematic review/Meta-analysis

  • Preparation of pre-clinical sections of the marketing authorisation dossier

  • Preparation of clinical sections of the marketing authorisation dossier

  • Preparation of the informative texts (SmPC, PL, labelling) of the marketing authorisation dossier

  • Preparation of preclinical and clinical expert statements

  • Handling of response phases during a marketing authorisation procedure

  • Preparation of further preclinical and clinical documents relating to marketing authorisation of a medicinal product (e.g. applications for orphan medicinal product designations, environmental risk assessments, paediatric investigation plans)

  • Preparation of other medical-scientific documents (e.g. publications, product rationales, medico-marketing material)

  • Candidate should have basic understanding of statistics and good data interpretation skills



If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don’t hesitate to contact us:


Ms. Vineeta  Bisht
Manager - Human Resources