Medical Information and Review Manager

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 Operations, the Medical Information Manager is primarily responsible for leading the medical review of materials and ensuring the accuracy, consistency, and scientific integrity of medical content. This includes supporting the medical review process for promotional and non-promotional materials, evaluating content for compliance with internal and external guidelines, and collaborating with cross-functional partners to align on key messaging.

The Medical Information Manager also develops and maintains standard and customized responses to unsolicited medical inquiries from healthcare professionals (HCPs) and non-HCPs (including patients and consumers), while serving as an internal expert on literature and data within assigned therapeutic areas. This role works closely with pharmacovigilance, quality, regulatory, medical directors/leads, field medical, commercial, and clinical development teams, as well as external partners.

Essential Duties and 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.

Education and Experience

•    Advanced degree in life or health sciences (MD, DO, PharmD, PA, NP, PhD) preferred. 
•    A minimum of 1 year of experience in Medical Information or Scientific Communications with a pharmaceutical company / vendor, including medical review of promotional materials
•    Completion of a pharmaceutical industry fellowship or a drug information residency is preferred.
•    Experience with rare diseases is preferred.
•    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 and review skills (e.g., literature searching, literature evaluation, data analysis, statistics)
•    Start-up or small company experience is preferred.

Knowledge and Skills

•    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.
•    Strong proficiency in Medical Affairs software systems (e.g., Veeva)

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, the employee may be required at times to attend meetings including travel out of state over weekends and nights. The employee must be able to freely operate and travel by car and train/plane modes of transportation. The employee is required to have a valid driver’s license and means of transportation.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to fly via commercial air carrier.

This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel

•    The location for this position is based at the RRD HQ office in New Jersey.
•    This position may require occasional domestic and international travel (less than 10%).

FLSA Classification

•    This position is considered Exempt.

EEO Statement

It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, state, or local law. Recordati Rare Diseases will provide reasonable accommodation for qualified individuals with disabilities.

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.

Disclosures

Pay Range (Base Pay): $120,000 - $165,000 Other Types of Pay: annual bonus Health Insurance: Medical, dental, orthodontia, vision, life & ADD, short and long term disability insurance benefits. Retirement Benefits: 401k Paid Time Off: Vacation, holiday, and sick/personal time