Description

Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for devastating rare diseases. At RRD, we focus on the few those affected by rare diseases. They are our top priority and at the core of everything we do.

RRD is a biopharmaceutical company committed to providing often overlooked orphan therapies to the underserved rare disease communities of the United States. RRD's mission is to reduce the impact of extremely rare and devastating diseases by providing urgently needed therapies. We work side-by-side with rare disease communities to increase awareness, improve diagnosis and enhance availability of treatments for people with rare diseases. Recordati Rare Diseases operates three business units including our endocrinology, metabolic and oncology franchises. RRD is committed to attracting, developing, and retaining the top talent in the pharmaceutical industry. We provide our employees with a dynamic work environment and the opportunity to grow professionally while making a difference in our patients’ lives.

Reporting Structure

Reports To: Senior Director, Medical Information & Operations

Direct Report(s): None

Areas Managed: Medical Information

Requirements

Reporting to the Senior Director, Medical Information, and Medical 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.

Essential Duties and Responsibilities

• Responsible for the development of Medical Information materials (eg, 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

• 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
• 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 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
• Excellent computer skills. Strong proficiency in Microsoft programs: Excel, Word, PowerPoint, as well as Veeva systems
• Fluent in English (oral and writing)

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, employee may be required at times to attend meetings including travel out of state over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. 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.