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A Division
of
GMP
Publications
& FDA.COM
"The GxP Family of
Quality Business"
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"We stand on a higher pillar of excellence!"
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Title |
Location |
Type |
Rate |
Apply |
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Scientific Affairs Manager |
West
Chester PA |
Perm/Full |
$80,000 - $95,000 |
Submit |
Scientific Affairs Manager
Overview:
This position has primary responsibility for
ensuring the adequacy of pre-clinical testing
protocols, including non-human in vivo studies.
This position is also responsible for
representing Company on national and
international standards setting committees and
will act as one of the Company' liaisons to the
academic research communities.
Responsibilities:
• Develop and implement standardized processes
for the timely construction of pre-clinical
safety and performance studies as required by
ongoing product development and regulatory
projects.
• Represent Company and participate on national
and international standards establishment
committees (i.e., ASTM, ANSI, ICH, etc.)
• Assist academic and clinical researchers in
the construction and conduct of scientifically
meaningful study protocols
• Provide guidance and direction in the
development of internal biomechanical test
methodologies
• Serve as company liaison to FDA on issues
concerning scientific research and testing
• Participate, as needed, in the identification,
review, and research of emerging or innovative
technologies
• Know and follow all laws and policies that
apply to one's job, and maintain the highest
levels of professionalism, ethics and compliance
at all times.
• Diligently participate in our compliance
program-related activities as denoted by your
supervisor or our Chief Compliance Officer.
• Promote and nurture the highest standards of
professionalism, ethics and compliance, and
actively support our compliance program-related
initiatives and activities.
• Consistently enforce employee compliance,
including attendance at training programs, and
promptly report any non-compliance to the Chief
Compliance Officer.
• Other duties as assigned
Qualifications:
• Minimum 10 years of prior experience in the
research and development of orthopedic or osteo-biologic
technologies
• Demonstrated understanding of the potential
effects of alternative or innovative
biomaterials, biologics and/or therapeutics
• Demonstrated ability to build professional
relationships within the academic and clinical
research communities
• Proven track record of the authoring and/or
critical review of scientific publications
• Strong knowledge of FDA Medical Device
Regulations and Guidances
• Multi-task and detail oriented
• Experience in Microsoft Excel, PowerPoint,
Microsoft Word
• Excellent oral and written communication
skills
• Ability (and desire) to work effectively in
collaborative, often-multi-discipline team
efforts
• Self starter who has the initiative, ability
and interpersonal skills to interface with
people inside and outside of the company
exhibiting the highest level of professionalism
• M.D. or Ph.D. in biomedical engineering,
molecular science, and/or biology.
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