Job Description

Summarized Purpose

Provides technical and medical information, and/or performs intake of adverse events/ product

complaints with quality customer service. Analyzes and researches inquiries and documents interactions according to organizational, client and regulatory guidelines. The information provided will be given to a level in parallel with the individual’s expertise, experience and training.

Essential Functions

•Responds accurately and professionally to technical and medical information inquiries received via phone, email, internet or mail in reference to pharmaceutical or device products. Processes fulfillments and provides clinical trial information or after-hours on call support.

• Analyzes caller’s questions to formulate an accurate and concise response using client-approved resources and records inquiries and interactions in the appropriate databases following organizational, client and regulatory guidelines.

• Identifies, records and triages adverse events and product complaints according to organizational, client and regulatory guidelines and provides additional support (including follow up) as needed.

• Maintains thorough knowledge of project and corporate policies and procedures including client products, SOPs, protocols, GCPs, and applicable regulatory requirements.

• Works closely with internal and external client contacts (up to and including

members of client management) to resolve complex inquiries. As needed, you will research medical literature and drafts responses for such inquiries.

Job Complexity

Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.

Job Knowledge

Learns to use professional concepts. Applies company policies and procedures to

resolve routine issues.

Supervision Received

Normally receives detailed instructions on all work.

Business Relationships

Contacts are primarily with immediate supervisor, and other personnel in the

department. Builds stable working relationships internally.

Qualifications

Education and Experience

BSN degree is required

Active North Carolina RN license required or Nurse Licensure Compact (NLC) equivalency.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

In some cases, an equivalency, consisting of a combination of appropriate education, training

and/or directly related experience, will be considered sufficient for an individual to meet the

requirements of the role.

Knowledge, Skills and Abilities

• Excellent verbal and written communication skills

• Excellent language skills (comprehension, speaking, reading and writing); Fluency skills in a    second language may be required

• Proficient computer and keyboarding skills

• Good interpersonal skills

• Ability to work independently as well as part of a team.

• Ability to interpret client provided complex medical and technical information

• Organizational and time management skills

• Ability to maintain a positive and professional demeanor in challenging circumstances

Management Role

No management responsibility

Working Conditions and Environment

• Work is performed in an office environment with exposure to electrical office equipment

• Constant interaction with clients/associates required

• Constant attention to detail-visual, mental

• Constant multi-tasking

• Daily exposure to high pressure, intense concentration needed

• Rotating shifts may be required

• Occasional driving to site locations with occasional travel

• Long varied work hours required occasionally

Physical Requirements

• Frequently stationary for 6-8 hours per day

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated   movements of the fingers, hands, and wrists

• Occasional mobility required

• Occasional crouching, stooping, bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. or 6-9 kgs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences

• Frequently interacts with others to obtain or relate information to diverse groups.

• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.

•Requires multiple periods of intense concentration.

•Performs a wide range of variable tasks as dictated by variable demands and changing conditions

with little predictability as to the occurrence

• Ability to perform under stress

• Regular and consistent attendance