Senior Standards Analyst

Senior Standards Analyst
Company:

Software Guidance & Assistance


Senior Standards Analyst

Details of the offer

Location: Madison, NJ
Bill : $87.49 HR
Job Description:
•Work with team of medical information professionals to manage the department workflow of unsolicited medical inquiries that are received by various sources (phone, email, voicemail, etc.) from health care professionals, consumers, and corporate business partners.
•Recognize and forward adverse drug events and/or product complaints in timely fashion to Pharmacovigilance and Quality departments, and document accordingly.
•Research and respond to requests for scientific/medical information using various search and retrieval techniques and medical literature database to develop a simple medical/scientific response (ingredient inquiries, SDS requests, poster/reprint/slide requests) that is accurate, fair balanced, complete and delivered in a timely manner.
•Escalate and triage global and complex inquiries and new standard response development (SRL) to the medical information specialists, as appropriate.
•Develop and generate scheduled and ad hoc reports for business metrics analysis Assist in staffing of the medical information booth according to the company policies and procedures.

Essential Job Functions:
•Work with team of medical information professionals to manage the department workflow and respond to requests for scientific/medical information using various search and retrieval techniques and medical literature database.
•Develop a simple medical/scientific response (ingredient inquiries, SDS requests, poster/reprint requests) that is accurate, fair balanced, complete and delivered in a timely manner.
•Recognize and forward adverse drug events and/or product complaints in timely fashion to Pharmacovigilance and Quality departments, and document accordingly.
•Ensure response time to Quality assurance requests is done within one business day.
•Escalate and triage global complex inquiries to the medical information specialists, as appropriate.
•Provide peer review of standard response letter (SRL) and development of short answer response (SAR) document.
•Develop and generate scheduled and ad hoc reports for business metrics analysis and provide information to management and internal medical teams.
•Provide training to field sales teams on current medical information request and dissemination policy. Represent department and provide compliance support for medical information activities in external venues.

Required Knowledge and Skills:
•Essential Skills and Abilities
•Analytical aptitude and clear, concise communication skills both verbally and in writing
•Attention to detail
•Knowledge and experience in use of computer systems and database and software applications, including Microsoft Office, Power Point, and Excel preferred

Minimum Qualifications:
•Education and Experience
•Minimum of B.S. degree with an emphasis in Science, Health Care or related fields from an accredited college or university and/or 1-2 years of pharmaceutical or related experience required.
Working knowledge of current Food and Drug Administration (FDA), and/or other US regulatory requirements and guidelines and knowledge of Allergan therapeutic areas and research interests desired


Source: Dice


Area:

Requirements

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