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.
Specialist/Senior Speecialist - Development Consulting & Scientific Affairs
1) Thorough knowledge of EMA and FDA regulatory guidelines
2) Excellent skills in literature search
3) Preparation of protocol, clinical study report, and other study related documents
4) Preparation of patient safety narratives of adverse events observed in clinical study
5) Manuscript writing, Systematic review/Meta-analysis
6) Knowledge of ABPI code of practice
7) Preparation of pre-clinical sections of the marketing authorisation dossier
8) Preparation of clinical sections of the marketing authorisation dossier
9 ) Preparation of the informative texts (SmPC, PL, labelling) of the marketing authorisation dossier
10) Preparation of preclinical and clinical expert statements
11) Handling of response phases during a marketing authorisation procedure
12) 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)
13) Preparation of other medical-scientific documents (e.g. publications, product rationales, medico-marketing material)
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. Aditi Panchal
Senior Specialist - Human Resources
Agencies only by prior agreement for the specific job opportunity.