Ley Gorrell ProSource

T e c h n o l o g y  and  S c i e n t i f i c  R e c r u i t i n g

We are currently recruiting for the following positions.  However, this is only a selection of our requirements nationwide.  If you don't quite see a description that matches your skills, talk to us!

Regulatory Affairs Manager:  Provide regulatory strategic direction as  leader of global and U.S. product teams.  Serve as principal interface with primary reviewers from health authorities (FDA, etc).  Develop regulatory strategies, provide direction on health authority interactions, prepare regulatory submissions and demonstrate leadership on the team to accomplish business objectives.  Coordinate activities of small groups of local personnel to ensure that tasks are completed within defined due dates and meet regulatory and departmental guidelines.  Manage special regulatory projects.  Qualifications:  BA/BS required.  3+ years relevant experience in pharmaceutical regulatory affairs.  Basic working knowledge of core processes: drug discovery, development, manufacturing, and marketing.  Demonstrated leadership, interpersonal, communication and organizational skills.  Northeast.  To $120K.

Pharmacoeconomic Director:  Responsible for conceiving, developing, researching, analyzing, managing, publishing, and presenting pharmacoeconomic and outcomes projects. Identify, develop, and incorporate economic and analytical measures into retrospective and prospective clinical studies. Assist in drafting protocols supporting scientific studies and interpret related health economic statistical data, develop economic models based on clinical data substrates. Lead the development and maintenance of product dossiers. Responsibilities for projects will include publication strategies and implementation. Qualifications: PharmD, MD, Ph.D., M.P.H., MS/MA Degree.  5+ years experience in Pharmacoeconomics, Economics, Statistics or Clinical Research.  Comprehensive knowledge of the pharmaceutical development process.  East and West coast positions.  To $150K.

Software Engineers: Design of complex embedded (C, C++, .NET) applications, enhancement, debugging, project management.  7+ years experience with stable work history, and strong object oriented/C++, RDBMS, and client server.  Looking for candidates in the midwest, as minimal reloe (OH, IL, IN, MI).  To $85K.
Structural Engineers - Minimum of BS Degree. Recruiting for full time positions in California, Florida, New York, Connecticut, and other locations nationally.  Qualifications:  Requires PE, SE, or EIT, and 1+ years professional experience with concrete structural building design (commercial, institutional, or healthcare facilities), and good people skills. Project management, seismic upgrade and renovation, or high rise experience a plus. Opportunities to team with top architectural/engineering firms with reputations for quality and superior design on high profile, large scale projects.  $60K - $120K.
Drug Safety Director: 

Product Engineers and Product Managers:  Leading medical device company looking for product development expertise in implantable devices or surgical instruments.  BS degree, and 3+ years practical mechanical engineering experience, and skills such as CAD, or program management in a highly regulated environment.  Company is growing, provides generous relocation package and bonus, with a no layoff policy.  Northeast.  To $75K.  

Senior CRAs and Clinical Research Managers: Prefer cardiovascular or oncology therapeutic areas on both positions.  CRAs will lead on Phase II studies, assist in protocol study/review, informed consents, case report forms, study reports/materials, and monitoring tools.  Provide input on processes, problem solving, and training.  Requires BS degree, 4+ years practical pharmaceutical/biotech industry experience, and knowledgeable in cGCP, ICH, etc.   To 95K.  CRMs will manage all aspects of assigned clinical studies,  participate in design/development of clinical trial protocols,  oversee development of   documents, contribute to clinical section of study protocol and assist in review. Chair or participate in meetings with study team, regional monitors and vendors (e.g. CROs, Central laboratories). Develop /direct clinical monitoring plan and priorities. Determine and manage clinical supplies required for conduct of clinical trials. Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites, CROs and/or regional monitors. Assist Medical Monitor with identification of tends in safety observed in the studies over time. Analyze/report safety issues, patient care issues, and study design and/or study conduct issues. Assist with the preparation of safety, interim and final study reports, and resolution of data discrepancies. Provide mentoring, leadership and guidance, clinical trial management and direction to in-house and contract CRA’s and support staff assigned to clinical studies.  Requires BS, 7+ years  experience in Clinical Research, including 4 years as a CRA at a sponsor company, extensive field monitoring experience and 2+ years in a role of primary clinical trial design and management responsibility. Requires knowledge of Clinical Research, including FDA regulations, GCPs, clinical trial design and documentation, and conduct of clinical trials. Must have the ability to: develop and administer clinical program budget and resourcing needs, schedules and performance requirements; handle routine staff management (including internal CRAs, in-house contractors and CROs).  To $120K.  West coast.

Mechanical Engineer:  Design, manage projects, and observe construction of building/facility mechanical systems for industrial, educational, institutional, government, and commercial projects, including HVAC, plumbing and special piping systems (such as for hospitals, labs), and fire protection.  May also meet with clients, assist marketing, estimate costs, travel, etc.  Requires a PE with a BSME, computer skills, and 7+ years in design/analysis of construction mechanical systems.  Southeast.  To $75K. 

Please submit resumes via e-mail to Ley Gorrell ProSource, in Word format. For more information, call (559) 338-3244.  At this time, we have no visa sponsorship or transfers available.