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.
Associate Director / Senior Manager, Regulatory Sciences & Scientific Writing
This role demands an ability to communicate effectively across the team and with clients, to act as an ambassador, displaying clear communication skills and comprehensive understanding of the PharmaLex organization.
Your Job
- Writing non-clinical, clinical, and pharmacovigilance CTD modules, responding to questions, audits.
- Supporting the writing of non-clinical and clinical study designs and protocols.
- Reviewing and/or writes non-clinical, clinical and safety documents and briefing packages for scientific advice
- Preparing scientific and/or regulatory papers for peer-reviewed or specialised journals and posters.
- Managing the development and implementation of operational practice, procedures, and guidance for teams
- Managing performance, quality of the services, internal and/or external resources and the budget of teams
- Acting as responsible person for the planning, management, coordination and financial control of assigned projects
- Providing strategic advice and/or operational services to clients
- Managing, supervising, supporting, and developing a team of consultants by providing strategic advice and/or operational services to clients
- Contributing to the development of impact measures and assessment methodology
- Ensuring adequate data is collected to enable us to report on service targets in line with GDPR.
- Providing strategic advice and/or operational services to clients
Your Profile
- Regulatory experience gained within a fast-paced environment
- Minimum 16/18 years of previous experience in pharmaceutical/biotechnical companies and/or regulatory authorities.
- Ideally a Graduate with a Life Sciences degree or equivalent qualification as a minimum.
- Ability to lead a team of permanent consultants and contractors by delegating and providing regular support and guidance in a professional manner.
- Manage employee’s needs and performance by assessing overall quality.
- Established relationships and proven negotiation skills with management, colleagues and/or regulators.
- Excellent verbal communication skills across multiple levels of an organization.
- Ability to represent the functional department at senior level meetings.
- Decisive and proactive, with “small company” hands-on, can-do style and attitude.
- Strong interpersonal skills & leadership.
- Demonstrable ability to coach, train and mentor teams.
- Ability to work on multi-projects in a multi-cultural and matrix environment
- Both English and French languages are a must
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:
talent.acquisition@pharmalex.com
Agencies only by prior agreement for the specific job opportunity.