Project Leader Associate (m/f)

The Company

Mithra Pharmaceuticals is a leading Belgian pharmaceutical company dedicated to women’s health. Founded in 1999, the company is a spin-off of the University of Liège and envisions becoming a world leader in women’s health innovation by developing and marketing innovative and accessible solutions with integrated R&D, commercial & technological platforms. Mithra’s mission is to generally improve women’s quality of life in four key therapeutic fields; contraception and fertility, menopause and osteoporosis, gynaecological infections and female cancer. Mithra Pharmaceuticals is based in Liège, Belgium and has five subsidiaries in France, Germany, the Netherlands, Luxembourg and Brazil.

Description Mithra Pharmaceuticals is looking for its R&D department for a Project Leader Associate, dedicated to the Estetrol Project.

Mission

 Assist the Project Leader in the project(s) coordination, which includes update of plans, timelines and budgets.  Ensure a good knowledge of the different parts of the Project(s), and review essential documents if required.  Support the responsible of Regulatory Affairs dedicated to the Project(s), by preparing and/or reviewing documents for regulatory submission and by handling part of administrative aspects. Contribute to the review of authorities’ feedback, by creating and updating Q&A listing.  Support the Non-clinical Leader dedicated to the Project(s) by participating to the coordination of the non-clinical studies, and by contacting sub-contractors in charge of studies.  Organize project meetings or others upon request, prepare for each meeting an agenda and the minutes.  Prepare and follow actions, activities, studies if required.  Ensure the documentation traceability and archiving in collaboration with the Project Leader or the dedicated responsible.  Collaborate closely with the accounting department for the follow-up of orders and invoices.  Upon request, collaborate with the legal department for contractual aspect with sub-contractor under the supervision of the Project Leader or the dedicated responsible.  For the allocated tasks, ensure the compliance with planning as defined with the responsible. In case of deviation, inform the Project Leader and suggest solutions. Profile

 Master or PhD in Biochemistry, Biology, Pharmacy or equivalent  Knowledge of GLP, GLP and GMP guidelines is required  Knowledge of Regulatory guidelines for pharmaceutical product development is required  Good knowledge of French and of English (spoken, written, read). Any other language is an asset  Project Management experience  Good knowledge of Microsoft Office  Good knowledge of ERP system is an asset  Flexible, able to set priorities and solution oriented  Autonomous, team player, strong communication skills (verbal & written) and cross functional collaboration skills  Organized, structured and conscientious  Resistant to stress

What we offer Varied and motivating responsibilities within a fast growing company. An attractive salary package in line with your experience

Application Send your CV and application letter to: [email protected]. Your email must mention following subject: MITHRA-PLA-042016.

Recruitment Agencies, please refrain from contacting us or sending us CVs on a spontaneous basis