Medical Information Associate II

• Provide scientifically accurate and balanced responses to medical inquiries from customers about clinical products, investigational therapies and disease states.

• Draft standard verbal responses (SVR) and standard letter bodies (SLB), with supervision, for clincal or drug products.

• Provide training to new Medical Information staff, students and fellows.

Job Responsibilities

• Using Genzyme MI US approved on- and off-label standard responses, reply to customer inquiries regarding company's marketed products, investigational therapies and disease states.

• Use the MI call-handling database to enter calls and responses, and generate response documents.

• Create / revise SVR and SLB scripts, with supervision, for information regarding company's marketed products and/or products submitted for regulatory approval; implement and maintain these documents in the MI document repository.

• Identify/archive current relevant literature utilizing the available medical literature databases (e.g.,In-house, MedLine, EmBase). Design and implement search strategies, with supervision, and conduct routine literature searches for creating responses.

• Clarify unique inquiries, gather and organize information for custom responses and differentiate between relevant and non-relevant data.

• Provide product / disease state/ database/ MI department training to new MI staff/students/fellows.

• Collaborate with the Global MI team and contribute to therapeutic area meeting discussions.

• Maintain training records and documentation of competence in current company's marketed products, departmental SOPs and MI software and databases.

• Conduct end-of-day reviews of MI call-handling database cases.

• Collaborate with other functional stakeholders (Commercial, Medical Affairs, Regulatory, Pharmacovigilance) on projects and processes (e.g., MRB, PRB, product dossiers, regulatory submissions).

• Perform other duties as assigned

Skills:

• Ability to work independently and with a team is essential.

• 1-2 years experience with word processing, spreadsheet and database applications and medical terminology.

• Excellent communication skills required.

• Pharm D or BS in a health care field (pharmacy ideal) plus 1-2 years experience with drug / product information, clinical trials or the regulatory process.

For more information, Please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960