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Principal Consultant Biologics and Advanced Therapies

Company: PharmaLex
Location: Haverhill
Posted on: August 4, 2022

Job Description:

PharmaLex is one of the largest providers of Development Consulting and Scientific Affairs; Regulatory Affairs; Quality Management & Compliance; and Pharmacovigilance, Epidemiology and Risk Management worldwide. Through 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 employer. - We respect and seek to empower each individual and support the diverse cultures, perspectives, skill, and experiences within our workforce. - We 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. -Key Responsibilities and Activities

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 bedsideClient interactions for scoping calls, workshops, presentation of complex strategic workshops, etc. Mentoring of other consultants, transfer of knowledgeReview and approval internal docs for release to clients If applicable, economic steering and observation of all global projects within dedicated serviceIdentification, training and coaching of dedicated employees globally in biopharma excellence in cooperation with the respective line managersCommunication with clients and participation in / organization of bid defense meetingsResponsibility / Accountability for the preparation of RFP/RFI and quotes in cooperation with the corporate and/or local sales and proposal teams Required Education, Experience, Skills and Competencies
  • Must have previous experience with biologics and/or advanced therapies including clinical and regulatory strategy Autonomous, concentrated and high-quality workAbility to work in a teamSense of responsibility Very good command of written and spoken EnglishAt least > 15 years of experience in biopharma drug development and approvalHas long-standing exposure to many different areas and different product classes with a broad and solid experience on how biopharmaceuticals are developed and regulatedDeep expertise in one product class
  • Lead project teams from client kick-off to final deliverable, contributing to and overseeing technical and regulatory activitiesSubject matter expert in more than one area relevant for biopharmaceuticalsAbility 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 planningMaintain 65% utilization on client projectsKey Performance Indicators
    Attainment of yearly goals according to agreementThe following Key Performance Indicators will be arranged individually with department specific measurements (if available) between Supervisor and job holder:Timely execution of projectsProject team members satisfaction/complaintsClient satisfaction/complaint**This is a remote -position. -Powered by JazzHR

Keywords: PharmaLex, Haverhill , Principal Consultant Biologics and Advanced Therapies, Healthcare , Haverhill, Massachusetts

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