Job Description Summary

The Global Medical Information Lead provides oversight and management of all activities pertaining to medical information inquiries for products marketed by Par Health (The Company) to ensure safe product usage and a regulatory compliant work environment. Responsible for providing technical and clinical information regarding product usage and performance. Clinically educate other members of the post-market surveillance team, call center and medical information vendor personnel, and other personnel within The Company as needed. Provide support and review of The Company’s medical and promotional material. Serve as the Business owner for the call center and medical information vendor/CRO to ensure compliant medical information globally.

Job Description

ESSENTIAL FUNCTIONS:

1.       Leadership of the medical information team

2.       Responsible for the compliance and trending of medical information inquiries with company procedures

3.       Composes and maintains standardized response letters (SRLs); serves as the business owner for SRLs

4.       Performs continual independent review of medical/scientific literature on The Company’s products and competitor's pharmaceutical products

5.       Critically evaluates medical/scientific literature and determine appropriate usage

6.       Provide support for medical review of The Company’s medical and promotional materials

7.       Participates on cross-functional teams concerned with development or support of products as needed

8.       Provides professional consultation in matters related to safety, efficacy, and proper product usage as needed

9.       Provides support for Pharmacovigilance and Product Monitoring (i.e. Health Hazard Evaluations, customer letters) as needed

10.   Serves as a member of the Signal Action Committee which performs medical and scientific review of safety signals that have been identified by the Pharmacovigilance department.

11.   Complies with all relevant related guidelines, standards and regulations pertaining to medical information provided to customers globally

12.   Maintains Standard Operating Procedures (SOP’s) for responding to unsolicited requests for medical information globally

13.   Collaboratively and effectively communicates with various departments, including Legal, Regulatory Affairs, R&D, Engineering, Business Development Leadership, Commercial, Pharmacovigilance, and Customer Service.

14.   Provide guidance to the call center and medical information vendor/CRO regarding the provision of medical information for The Company’s products globally, including ensuring the vendor has the most recent product labeling for each country. Monitor the vendor/CRO’s performance and adherence to company policies and procedures.

15.   Performs internal quality assessments and medical review of information provided by The Company’s personnel.

16.   Acts as the subject matter expert for medical information during audits and regulatory inspections. Participate in the drafting of audit and inspection responses and assist in the coordination and completion of corrective actions related to audits and inspections.

17.   Prepare and deliver accurate medical information and other post-market reports on regular and ad-hoc basis and identify potential performance issues and alert appropriate management personnel when needed.

18.   Identify, hire, train, develop and manage medical information specialists.

MINIMUM REQUIREMENTS:

Education:

Advanced degree in relevant medical specialty required (i.e. PharmD, RPh, Physician’s Assistant (PA), etc.)

Experience:

1. A minimum of five years of clinical/practical experience in a relevant clinical environment or related Post-Market Surveillance experience in the pharmaceutical and/or medical device industry.

 

Preferred Skills/Qualifications:

1. Healthcare certification

2. Previous Medical Affairs, Regulatory Affairs, and or Medical Communications experience in the pharmaceutical industry

3. Experience interacting with regulatory agencies such as the FDA.

4. Writing skills necessary to effectively communicate technical/clinical information to others.

 

Skills/Competencies:

1. Flexible leader

2. Highly self-motivated

3. Strong Communication and Presentation skills

4. Problem Solving and Scientific evaluation skills

 

Other Skills/Competencies:

1. Sound organizational skills with the ability to prioritize tasks

2. Ability to build productive relationships with personnel within and outside of the department and company

3. Demonstrated ability to manage complex processes and cross-functional teams

 

 

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

·         Reports to the Product Monitoring and Medical Information Lead

·         Manages a team that includes professional individual contributors

·         Interact with a variety of departments and locations.  These include, but are not limited to, Legal, Regulatory Affairs, Product Monitoring, Pharmacovigilance, R&D, Marketing, Quality Assurance, Sales, and Customer Service.  The degree and scope will vary according to the needs of the departments involved

 

WORKING CONDITIONS:

·         Normal office conditions, which include sitting for long periods of time and computer and phone use.

·         Occasional travel may be required for such things as training seminars, manufacturing site visits, and professional/trade conventions.

 

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.