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Pharmalex is one of the largest providers of development consulting and scientific affairs; regulatory affairs; quality management & compliance; and pharmacovigilance, epidemiology and risk management worldwideThrough our us, european and asia-pacific offices, our trusted consultants provide specialized, regulated services to pharma, biotech and medtech industries to help them successfully meet the regulatory challenges of bringing products to market and helping them to maintain their product portfolios following launch.
We are currently looking for an experienced professional for management or leadership of biopharma consulting projects and continuous development of international biopharma excellence services as well as leading, developing and coordinating an international team, of international projects and initiatives as assigned.
Pharmalex is a proud to be an equal opportunity employerWe respect and seek to empower each individual and support the diverse cultures, perspectives, skill, and experiences within our workforceWe believe that diversity and inclusion among our teammates is critical to our success as a global company and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.
Principal consultant biologics and advanced therapies
Your job
Scientific or project lead on multiple, possibly simultaneous biopharmaceutical projects
Strategic input into and management of global regulatory agency meetings and submissions
Research and recommend global integrated product development and regulatory/clinical strategy, as well as navigating clients through the development process from bench to bedside
Client interactions for scoping calls, workshops, presentation of complex strategic workshops, etc.
Mentoring of other consultants, transfer of knowledge
Review and approval internal docs for release to clients
If applicable, economic steering and observation of all global projects within dedicated service
Identification, training and coaching of dedicated employees globally in biopharma excellence in cooperation with the respective line managers
Communication with clients and participation in / organization of bid defense meetings
Responsibility / accountability for the preparation of rfp/rfi and quotes in cooperation with the corporate and/or local sales and proposal teams
Your profile
Must have previous experience with biologics and/or advanced therapies including clinical and regulatory strategy
Autonomous, concentrated and high-quality work
Ability to work in a team
Sense of responsibility
Very good command of written and spoken english
At least > 15 years of experience in biopharma drug development and approval
Has long-standing exposure to many different areas and different product classes with a broad and solid experience on how biopharmaceuticals are developed and regulated
Deep expertise in one product class
Lead project teams from client kick-off to final deliverable, contributing to and overseeing technical and regulatory activities
Subject matter expert in more than one area relevant for biopharmaceuticals
Ability to develop customized solutions to assist clients in moving asset through development
Can solve very difficult technical questions
Examples: development strategy, review/gap analysis of programs, dossier preparation and review, risk assessment, scenario planning
Maintain 65% utilization on client projects
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.
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Posted 4 days ago
