Pharmaceutical Clinical Associates, LLC
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Scarborough,
ME
Summary
Responsible for the coordination and monitoring of domestic and/or international studies undertaken by the company in support of research, marketing/sales, and regulatory objectives with limited oversight/supervision. This includes the coordination of all product registration, regulatory submissions, and related activities for domestic and international markets.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Participate in the independent evaluation of study proposals for consistency with company objectives, regulatory compliance requirements, and adequacy of study design
Develop and write protocols for company supported studies with input from technical, quality assurance, and marketing personnel and, as appropriate, regulatory agencies
Initiate and monitor assigned clinical/research studies in compliance with all applicable regulations and company procedures
Critically analyze and evaluate clinical data presented in literature or generated as part of company sponsored studies
Establish and maintain professional relationships (in person, by phone and/ore email) with clinical investigators and regulatory contacts (agency and distributor) as necessary to support clinical studies and regulatory submissions
Compose documents for regulatory communications including submissions (pre-IDE, 510(k), PMA, CLIA Waiver, registration dossiers)
Actively monitor status of communications with regulatory agencies and clinical study sites
Maintain and manage clinical study and product registration activities in database systems, consistent with company timelines and objectives
Construct in-house regulatory files
Continue to develop regulatory knowledge of worldwide IVD requirements and coordinate assigned product registration activities
Support all clinical affairs activities as needed
Up to 20% domestic and international travel time spent in support of clinical studies or product registrations
Experience and Skills:
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
Bachelor's degree (BA/BS) (chemistry, biology or other science preferred) or equivalent combination of education and experience
Two to five years experience in clinical study coordination, interpretation of FDA or international regulations, and/or in biotechnology or related industry required
Experience in regulatory submissions (510(k), Technical File, PMA, IDE) desirable
Additional Information:
Job Level: Mid Career (2+ years)
Number of Openings: 1
Years of Experience: At least 2 Years
Level of Education: Any
Salary: TBD
Starting Date : TBD
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Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
Scarborough, ME
Scarborough, Maine
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