Shall work closely with candidate drug selection team and support preclinical and ealy clinical phases of small and large molecule drug development and lead Model Based Drug Development planning and implementation.
Must have experience in Model Based Drug Development and independently developing pharmaco-statistical models including disease, exposure response, biomarker, efficacy, etc. in collaboration with physicians, DMPK PK-PD scientists, statisticians, clinical pharmacologists and regulatory ...
Director Regulatory Affairs, Area & Affiliate US/Canada-
PRIMARY JOB FUNCTION:
Candidate will be responsible for contributing to and implementing strategies to support assigned projects within Therapeutic Area (e.g., HCV).
CORE JOB RESPONSIBILITIES:
• Review, compile, and submit variations, new applications, supplements and amendments, as well as responses to Health Authorities as needed
• Development, defense, and implementation of robust Regulatory Strategy and Tactical plan for ...
Senior Director, Regulatory Affairs, Area & Affiliates US & Canada
Primary Job Function:
The function of a Senior Director Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has division and corporate level influence and is generally considered a key opinion ...
Director, Regulatory Affairs CMC
• Lead a team of global regulatory professionals who develop strategy for development and marketed products, and manage the content of global regulatory dossiers
• Key internal leader and driver of regulatory policy and strategy
• Influence the development of regulations and guidance
• Provide executive management with meaningful regulatory measurements and regulatory opinion
• Partner with outside regulatory agencies and trade ...
Engineer (1 year Contract position)
This position is expected to participate primarily in design history file (DHF) remediation initaives for client’s Disposables Elastomerics R&D organization. Other elastomerics sustaining project initiatives may also be within scope of this position.
1) Perform standard engineering assignments which are typically a significant portion of a larger project. Select sound techniques to solve problems and make recommendations under direction of supervisor. Assess ...
Primary Function / Primary Goals / Objectives:
Leads and directs all marketing activities for the assigned product line(s) or business. Responsible for the development, management, and execution of strategies and tactical programs to effectively achieve commercialization, profit margin and business plan objectives. Directs and supervises a staff including two or more Marketing Professionals. Additional responsibilities include business strategic planning, concept evaluation forecasting, financial ...
PSI CRO AG - Home-based - Southeast Region - Oncology Experienced
PSI is expanding rapidly in the US and seeking highly motivated CRAs. At PSI, we believe employees are our greatest assets.
Responsibilities: Project activities and monitoring functions associated for Phase I-IV clinical research studies. Comprehensive understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations. Demonstrates a high level of communication skills and provides clinical and ...
Seeking degree in chemistry, biology, engineering or similar and leadership track record in biological pharmaceutical manufacturing quality compliance who is expertly familiar with biopharmaceutical manufacturing operations, documentation management, training, and auditing.
*** Supervising RA and QA associates and contractors.
*** Oversight of corrective and preventive actions.
*** cGMP and GMP Document management.
*** Coordinating and maintaining cGMP and GMP training program.
Jan 21 -
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