Medochemie Ltd is an International Pharmaceutical Company headquartered in Cyprus. Medochemie manufactures a wide range of products divided into more than 10 therapeutic categories, owns 3800 marketing authorizations, and operates in more than 107 countries around the world. Our thirteen separate manufacturing sites are designed to fully comply with European and WHO current Good Manufacturing Practice (cGMP).
We ‘re on a mission to find the best talent out there. We are now looking for a talented Clinical Manager (Bio Equivalence Expert) to join our team in any of our offices in Bucharest, Athens, Limassol, Sofia, Amman, Cairo.
What the job looks like?
The Clinical Manager (Bio Equivalence Expert) will have the opportunity to:
- Evaluate, design, and oversee Bioequivalence clinical studies
- Reviewing protocols and reports for EU and non-EU applications
- Reviewing and approving relevant sections of clinical protocols, analysis plans, study reports, and regulatory submissions
- Maintaining a high standard for good clinical practice, compliance, and ethics
- Maintaining and establishing relationships and agreements with contract vendors
- Providing detailed clinical input and feedback in support of product registration
- Providing authoring support for Bioequivalence clinical-related documents
- Solving problems during clinical trials
- Analysing and presenting Bioequivalence related data to internal project teams and senior management
- Determining strategy to resolve deficiency questions from the Agencies and path forward to complete additional activities to support responses
What does it take to do the job?
- University degree in Medicine , Pharmacy, or a related field
- A minimum of 5 years’ experience as an expert in monitoring Bioequivalence studies for generic medicines is a must
- Knowledge of EMA and AESEAN guidelines for Bioequivalence studies
- Ability to work collaboratively in cross functional groups in a matrix team environment
- Ability to multitask and work under pressure with commitment to timelines
- Excellent interpersonal and communication skills including ability to communicate scientific information clearly and effectively.
- Excellent computer literacy
- Analytical thinking and problem-solving skills
- Proficient in the English language with excellent written and verbal communication skills
It would be considered a plus if you have:
- Postgraduate degree in a related field
- Experience/knowledge in CTIS application is an advantage
- Familiarity with formulation development is preferred
- Experience evaluating and selecting vendors for clinical studies will be considered an asset.
By joining us you can expect
- A unique opportunity for a career in a fast-growing company
- Competitive remuneration package based on qualifications and experience
- Modern & Professional Work Environment Opportunities to learn and develop yourself through our ‘Employee Training & Development Path’
Applicants should note that based on the General Data Protection Regulation (GDPR), all applications/CVs are kept in our database based on the consent period each candidate applied for. In case you have forwarded us your CV in the past and you are interested in this position, please apply again.
All applications will be treated with strict confidentiality. Only shortlisted candidates will be contacted.
If you believe that you have the above qualifications and this position sounds challenging, submit your application through the link below:
http://www.medochemie.com/MainMenu/Careers.aspx