Senior Medical Information Manager

R&D Remote, Remote


Description

Job Summary - a concise overview of the job

The Senior Medical Information Manager has the primary responsibility to support Medical Information services in preparation for the launch and continued medical support needed for Endo Products. This role will be responsible for scientific/medical review of all promotional materials for HCPs, Consumers and Sales Training, provided through the Medical and Promotional Review Committees (MARC and NPRC).  

 

This role will develop the medical information database of all published literature, presentations and posters, and the development and approvals of the Standard Response Letters (SRLs) and Frequently Asked Questions (FAQs) anticipated to be needed for HCP and Consumer Medical Inquiries, received by the Call Center pre-launch, at launch and post-launch. 

 

This individual will also be responsible for all Call Center Training for Disease State and Product Pivotal Data as well as Work Instructions and Handling Guides necessary to insure complaint and fair balanced Medical Inquiry responses for Endo Products.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Support activities of the Medical Information Associate Director and the broader Medical Information Department activities.

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

MARC/NPRC Support

 

§  Review of promotional and non-promotional material      medical/scientific accuracy/relevancy for the Marketing and Advertising Promotional and Non-Promotional Review Committees.

§  Work closely with Research and Development, Clinical Operations, Regulatory, and Legal to coordinate development, approval, and communications of all related Clinical Studies and Clinical Data to enhance and support the safe and effective use Endo products, to optimize patient outcomes.

§  Ensure that publication and presentations regarding Endo products  will be accessible to HCPs.

50%

Call Center

§  Lead individual for responding to escalated questions from professional call center, field sales, and field Medical Affairs. 

§  Serve as a point of contact for call triage exceptions not otherwise addressed adequately by adverse event handling, product complaint handling, medical/product information inquiries, and customer service (i.e., returned goods policy) and coordinate teams of individuals to address HCP and consumer concerns.

§  Write, review, and respond to out of scope requests by performing critical literature evaluations and researching previous out of scopes.

§  Research, review and respond to requests for medical information necessary for label updates as requested by Regulatory.

§  Assist in analyzing the customer insights from call center data.

25%

Database Management

§  Ensure that the Medical Information database is accurate and up to date.

§  Manage the internal review process for all SRLs and FAQs through the Non-Promotional Review Committee (NPRC) database, as appropriate.

§  Provide oversight to insure accuracy of the Call Center’s Work Instructions and Handling Guides.

§  Manage annual review schedule for all SRLs and FAQs.

§  Actively participate in writing and review of new and existing SRLs and FAQs.

§  Update and/or create SRLs and FAQs across all therapeutic areas.

25%

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

§  PharmD or PhD in health science related field with a minimum of 3+ years of experience in medical writing or medical communication activities, or

§  MS in biological sciences or RPh./B.Pharm./RN with 5+ years of experience in medical writing or medical communication activities.

§  Experience supporting a pharmaceutical company medical information department and/or supporting a medical information call center.


Knowledge

Proficiency in a body of information required for the job   

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  Strong knowledge of FDA regulations regarding drug promotion and dissemination of medical and product information.

§  Compliance standards as they relate to Medical Information activities.

§  Knowledge of medical information processes and industry standards.

§  Knowledge of federal regulations pertaining to the fair and balanced promotion of medicines.

§  Strong knowledge of medical terminology, pathophysiology, pharmacology, and pharmacotherapeutics.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

§  Customer-oriented approach and ability to effectively work in cross-functional teams.

§  Ability to prioritize and manage completion of multiple deliverables simultaneously with high quality and professionalism.

§  Strong biomedical literature evaluation and medical writing skills.

§  Advanced computer literacy, particularly MS Office.

§  Excellent verbal, written, and overall communication skills.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

§  Up to 15% domestic overnight travel.

This position is primarily remote with the expectation that travel is required to the Malvern, Pennsylvania office one time per month.