Regulatory Affairs/Quality Assurance and R&D Opportunities
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Sr. Scientist Health Economics & Outcomes Research - East Coast
Leads client engagements, including providing regular project status reports internally both to the project team and members of senior management, and externally to members of client organizations. Develops/oversees appropriate methodologies and coordinates study logistics, including selection of data for abstraction, data summaries, evaluation of variables, development of health economic models using spreadsheets and decision-analytic software, design of questionnaires and surveys, preparation of study materials such as investigator meeting agendas, IRB forms, consent forms, protocols, and CRFs. Collaborates on proposal drafts for project work, including clear articulation of key issues, goals and objectives, approach, means for managing project team and communicating with client, description of deliverables, and accurate time and budget estimates. Conducts background research and outcomes strategy development on therapeutic areas and products; identify key clinical research, define potential unmet medical need, articulate product profile and associated potential value messages for key stakeholders, propose preliminary ideas for elucidating health economic value, and meet with prospective clients to demonstrate firm’s understanding of commercial challenges. Educational & Experiential Requirements: Minimum 5 years experience in biopharmaceutical outcomes research, Advanced degree in the fields of medicine, pharmacy, public health or nursing, 3 years clinical practice preferable. Contact Mike Strieker at 217-479-8088 ext. 302 or email mls@advancedrecruiters.com for further details.
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Associate Director, Regulatory Affairs, New Products
The Associate Director is primarily responsible for the development, management and training of personnel within the department. Oversight of drafting, revision and completion of paper and electronic submissions to support development plans for IND, NDA, & ANDA while maintaining regulatory expertise regarding the FDA are pertinent. Qualifications should include a Bachelor, Masters or Doctoral degree with at least 5 years industry experience in NDA regulatory affairs and 3 years managerial experience. Experience in CNS therapeutics is preferred, but not mandated. If you or a colleague is interested in learning more about this lucrative opportunity with a pharmaceutical company developing and manufacturing generics within the areas of cardiology, dermatology, women's health, and most recently, neurology, please contact me by email lam@advancedrecruiters.com or phone, 217-479-8088 ext. 300.
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Director, International Regulatory Affairs - Bay Area CA
This position is responsible for directing regulatory affairs activities in support of the global commercialization of products developed. The position oversees the creation, filing, review, and maintenance of license applications in markets outside of the US and Western Europe. The position is also responsible for ensuring that advertising and promotional materials are in compliance with US and applicable international law. The position will oversee a group of 5 with 2 direct reports. Requirements include: A bachelor of science degree in a life science is strongly preferred; 8+ years of industry experience including at least 6 years of experience in Regulatory Affairs are required. The candidate must have substantial experience in international regulatory affairs. The candidate must also have experience in reviewing and approving advertising and promotional materials in line with US and applicable international laws. Strong collaborative skills are needed as this position requires close working relationships with stakeholders both inside and outside of the company. Excellent verbal, written and presentation skills are also required. Please contact Mike Strieker for further details at 217-479-8088 ext. 302 or email mls@advancedrecruiters.com.
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