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 CCH. 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 Center pre-launch, at launch and post-launch.
This individual will also be responsible for all 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 in preparation of the launch of CCH.
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 Director and the broader Medical Information Department activities.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
§ Review of promotional and non-promotional material from a medical/scientific lens 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 around the commercialization of this product, to optimize patient outcome.
§ Ensure that publication and presentations regarding CCH will be accessible to HCPs and in particular, KOLs who utilize these data for their professional society presentations and aesthetic courses.
§ Lead individual for responding to escalated questions from professional center in collaboration with peers in Medical Affairs.
§ Serve as a point of contact for 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 center data.
§ 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 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.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ PharmD or PhD with a minimum of 4 +years of experience in medical writing or medical communication activities, or
§ MS in biological sciences or RPh./B.Pharm. with 9+ years of experience in medical writing or medical communication activities.
§ Experience supporting a pharmaceutical company medical information department and/or supporting a medical information center.
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.
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 skills.
§ Advanced computer literacy, particularly MS Office.
§ Excellent verbal, written, and overall communication skills.
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.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.