Medical Affairs Operations Specialist

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 and Medical Operations

Direct Reports: None
Areas Managed: None

Overview

The Medical Affairs Operations Specialist will provide operations support to the Medical Affairs group. This role requires strong organizational, project management, and cross-functional collaboration skills to ensure smooth execution of contracts, budgets, grants, and medical review committee activities.

Essential Duties and Responsibilities

•    Processing correspondence, proposals, presentations, spreadsheets and reports such as filing and tracking of fully executed contracts, setting up new vendors and assisting with processing of statements of work, purchase orders and contracts through the set up and execution process.
•    Oversee full contract lifecycle (CDA, MSA, SOWs, Consulting Agreements), vendor onboarding, and contract tracking/filing.
•    Process and reconcile POs, SES, invoices, and accruals; ensure timely vendor payments and accurate reporting.
•    Monitor grant submissions, coordinate reviews, manage grantee communications, execute letter of agreement (LOA), and ensure proper reconciliation.
•    Medical Review Committee Coordinator (MRC): Lead scheduling, coordination, VVMC workflows, and documentation of approvals and outcomes.
•    Maintain systems and tools used by Medical Affairs, including but not limited to Asana, Mobile Locker, and Veeva Vault MedComms. Provide department with user training/support.
•    Prepare quarterly executive summaries, maintain trackers, support team meetings, and perform other operational duties and ad hoc projects as assigned.
•    Support ad hoc projects.
•    Perform other duties as may be assigned.

Education and Experience

•   Bachelor’s degree required, preferrably in life/physical sciences.

•   Project management certification - preferred
•   2+ years of experience in administration and/or office services, preferably in a Pharma environment.

Knowledge and Skills

•    Familiarity with systems such as Veeva, Asana, Mobile Locker, and financial tools (SAP systems).
•    Attention to detail
•    Demonstrated ability to manage multiple priorities in a fast-paced work environment
•    PowerPoint and scheduling experience
•    Self-starter, able to manage ambiguity
•    Manages confidential information appropriately
•    Planner/organizer
•    Fluent in English (oral and writing)
•    Flexible and adaptable
•    Well organized
•    Positive thinking and enthusiasm
•    Able to work in a small – middle size company
•    Project management experience a plus
•    Excellent time management and ability to work independently
•    Familiarity with FDA approval procedures
•    Excellent computer skills. Strong proficiency in Microsoft programs: Excel, Word, PowerPoint, Access

Competencies and Attributes

•    Behaves in an honest, fair and ethical manner.
•    Pursues self-development.
•    Communicates in a clear, concise and convincing manner. Listens effectively.
•    May be called on to assist in developing new members of the company.
•    Responsible for tactical implementation of pre-defined programs and projects.
•    Solves issues of moderate complexity.
•    Works independently on issues where analysis of situation or data requires evaluation of different factors.
•    Monitors expenditures.

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 the New Jersey office.
•    Opportunity for Hybrid role.
•    The position may require some travel (<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 accommodate for qualified individual 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

Annualized Pay Range (Base Pay): $68,000 - $93,000 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.