We are growing, grow with us!
Are you looking for a dynamic company with daiky challenges and opportunities?
Then, Pharmalex is your next career move! Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally, specialised in all aspects of drugs and medical devices approval of the market development, and any action of effective product maintenance.
Senior Manager, Development Consulting & Scientific AffairsYou are accountable for the execution of operational tasks in the field of the Development Consulting & Scientific Affairs (DCS) department that requires established experience and specific scientific expertise in the sector of human medicinal products. Responsible for supporting and delivering assigned DCS related activities in collaboration with other PharmaLex affiliates, and other VDCs, notably in close collaboration with Regulatory Department.
- Responsibility for assigned tasks within the Regional DCS department
- Participation in DCS and/or cross-VDC projects as Team member or Project Lead, as applicable
- Responsible for the planning, filing and prosecution of approved projects.
- Lead Regional or Global project
- Identification of resource/ staffing needs and reports to Management
- Support and if applicable lead in preparation, quotation and invoicing for Regulatory Affairs Projects in close cooperation with the respective team lead
- Support for acquisition of new customers (participation in bid defence meetings, proposal writing…) in cooperation with sales organisation, VDCs and other service/ISLs
- Presenting seminars and lectures to PharmaLex colleagues, for customers or for professional audience
- Contribution to optimizing French/Regional offices and departmental processes and organization.
- Share experience with French/Regional offices and more globally with other PharmaLex colleagues.
- University degree in pharmacy or other discipline in Life sciences
- Very good knowledge of Drug Development and related Agencies requirements (eg EMA, FDA, PMDA, etc)
- Proven experience in evaluation, preparation and compilation of regulatory documentation and/or experience in regulatory processes (but not limited to registration procedures, consultations to health authorities, etc)
- Ability to translate strategic goals of partnerships/customers or internal projects into tactical goals
- Autonomous, concentrated and high-quality work
- Very good written and spoken communication skills with internal and external customers, colleagues and supervisors
- Ability to manage and lead a project in full autonomy
- Excellent team player
- Ability to develop and deliver presentations
- Ability to assimilate and analyse information rapidly
- Ability to identify and offer solutions to problems in a pragmatic way
- Ability to adjust rapidly to new, unknown, challenging situations
- French language is a must; Fluent English
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.
Agencies only by prior agreement for the specific job opportunity.