Medical Information Manager

Recordati • Bridgewater, NJ

1d • $100,000 - $150,000 • Onsite

About The Position

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. RRD is dedicated to fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.Reporting Structure Reports To: Senior Director, Medical Information & Operations Direct Report(s): None Areas Managed: Medical Information Overview Reporting to the Senior Director, Medical Information, and Medical Affairs Operations, the Medical Information Manager is primarily responsible for generating standard and customized medical information content to fulfill unsolicited Medical Information requests from both healthcare professionals (HCPs) and non-HCPs (including patients and consumers). The Medical Information Manager also serves as the internal expert on literature related to assigned therapeutic areas and has related responsibilities across functions. The role will interface with multiple cross-functional teams including pharmacovigilance, quality, medical directors/leads, field medical team, commercial, regulatory, legal, and clinical development as well as external partners.

Requirements

• An advanced degree in pharmacy, nursing, or medicine (PharmD, NP, DNP, MD, PA) from accredited US or foreign medical school is required.
• A minimum of 1 year of experience in Medical Information or Medical Communications with a pharmaceutical company / vendor, including medical review of promotional materials
• Knowledge of applicable regulatory and legal requirements for the provision of medical information in the pharmaceutical environment
• Knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing medical information in post-marketing products
• Demonstrated ability to work in a matrix environment.
• Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data in English.
• Demonstrated advanced medical information skills (e.g., literature searching, literature evaluation, data analysis, statistics)
• Ability to build an excellent partnership with an outsourced partner, maintaining strong relationships while simultaneously holding the outsourced partner to high standards.
• Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details.
• Ability to work collaboratively and coordinate the efforts of team members to resolve comments and produce a final high-quality document.
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
• Excellent computer skills. Strong proficiency in Microsoft programs: Excel, Word, PowerPoint, as well as Veeva systems
• Fluent in English (oral and writing)

Nice To Haves

• Completion of a pharmaceutical industry fellowship or a drug information residency is preferred.
• Experience with rare diseases is preferred.
• Start-up or small company experience is preferred.

Responsibilities

• Responsible for the development of Medical Information materials (e.g., standard response documents, custom response documents, technical response documents, frequently asked questions) for external customers and internal business partners that are accurate, relevant, scientifically balanced, and in accordance with relevant SOPs and regulations.
• Provides timely, accurate, thorough, and scientifically-balanced responses to escalations from the Medical Information Contact Center (MICC)
• Provides on-going support and training to MICC agents and other relevant individuals on new or updated Medical Information content.
• Serves as a Medical reviewer for the Medical and/or Promotional review committee.
• Regularly monitors the quality and accuracy of the Medical Information responses and identifies necessary corrective actions or training required to ensure compliance with regional and local regulations as well as internally relevant SOPs.
• Develop and maintain a deep knowledge of product, disease state, and competitor knowledge for assigned therapeutic area.
• Mentor post-doctoral fellows, interns, and/or other learners
• Serve as a Medical Information resource for internal business partners.
• Ensures prompt and accurate reporting of adverse events or product complaints in accordance with relevant SOPs and regulations.
• Ensures compliance to Medical Information standard work practices and operating procedures.
• Support audit readiness for Medical Information
• Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities.
• Perform other duties as assigned.

Benefits

• Comprehensive medical, dental, orthodontia, and vision coverage; life and AD&D insurance; short- and long-term disability benefits
• 401(k) retirement savings plan
• Vacation, holiday, and sick/personal time in accordance with company policy and applicable law

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree