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Clinical Affairs Specialist - In Vitro Diagnostics
Company: Siemens Healthcare Diagnostics Inc.
Division: SMSD - Diagnostics
Location: CA - Berkeley
Req ID: 126279
Position Title: Clinical Affairs Specialist - In Vitro Diagnostics
Experience Level: Senior Level
Education Required: Bachelors Degree
Travel Required: Yes
Company Description:
Siemens’ Healthcare Sector is one of the world's largest suppliers to the healthcare industry and a leader in medical imaging, laboratory diagnostics, medical information technology and hearing aids. Siemens Healthcare offers its customers products and solutions for the entire lifecycle of patient care – from prevention and early detection, to diagnosis, treatment and aftercare. By optimizing clinical workflows for the most common diseases, Siemens also makes healthcare faster, better and more cost-effective. Siemens Healthcare employs over 50,000 employees worldwide. In fiscal year 2011, the Healthcare Sector posted revenue of 12.5 billion Euros. For more information on the Healthcare sector, visit: www.siemens.com/healthcare
Job Description:
Position Overview
Develops study protocols including risk rationales and/or advises the company on the appropriate study design. Guides the Quality department to ensure that appropriate levels of clinical and preclinical testings are completed prior to U.S. introduction. Guides the Quality department to ensure that proper local approvals are obtained and agreements are executed prior to installation. Guides and/or trains on the implementation and conduct of clinical and preclinical studies to assure data are collected in timely and cost effective manner and is consistent with regulatory standards. Guides the tracking of contracts and budgets for the studies. Guides efforts among internal departments to ensure clinical and pre-clinical data is collected to withstand regulatory investigations. Guides and develops clinical and preclinical regulatory submissions to support study data. Develops and conducts pre-study collaborative meetings with investigative and regulatory agencies.
Responsibilities
Performs advanced areas of work for the professional field. Applies advanced skills to resolve very complex problems not covered by existing procedures or practices independently. Displays a high level of critical thinking in bringing successful resolution to high-impact, complex, and/or cross-functional problems.
Required Knowledge/Skills, Education, and Experience
BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
Demonstrates and applies comprehensive knowledge of field of specialization to the successful completion of complex assignments. Demonstrates advanced knowledge of concepts, practices, and procedures of particular area of specialization. Demonstrates significant knowledge of organization's business practices and issues faced and contributes to problem resolution of those issues.
Typically 2 or more years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable.
Candidate must have excellent organizational and leadership skills, and possess excellent verbal and written command of English.
Knowledge and understanding of FDA 21 CFR Parts 11, 50, 54, 56, 812, 814, and ICH Good Clinical Practices required.
Preferred Knowledge/Skills, Education, and Experience
Experience with invitro diagnostic and related products, and working knowledge of EU IVDD requirements strongly desired.
*LI-CMC
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, ancestry, national origin, sex, sexual orientation, gender identity, age, disability, marital status, family responsibilities, pregnancy, genetic information, veteran or military status.
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