Head of US Medical Affairs Operations

Date: Nov 5, 2024

Department: Medical Affairs

Job Type: Direct Employee

Team: Mktg, Market Access, Bus. Excellence & Med. Affair

Contract Type: Permanent

Location:

Cary, NC, US

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi USA

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.

What we offer

Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that “Every one of us is different. Every one of us is Chiesi."

Who we are looking for

Purpose

The Head of US Medical Affairs Operations is a pivotal role that offers strategic project management expertise and oversight to support the Medical Affairs team in the areas of project management, independent medical education, ISS, field medical excellence and financial accountability with an eye toward process improvement. This role necessitates a comprehensive understanding of Medical Affairs and a strong emphasis on project management, strategic thinking with a strong eye to tactical execution. This role will act as a central point of coordination and leadership, ensuring seamless communication and effective collaboration in Medical Affairs. This individual will also play a key role in driving strategic Medical Affairs initiatives, managing critical projects, and ensuring the overall efficiency and effectiveness of the Medical Affairs team.

Main Responsibilities

Contribute to development of mid and long-term strategy for Medical Affairs in partnership with the Vice President, Medical Affairs.
Provide strategic project management skills to support activities across Medical Affairs and cross-functionally.
Partner with different functions within medical affairs (therapeutic area, field medical team, medical communications/ information, and real-world evidence) to enhance the organization’s effectiveness in decision making and delivery, facilitate communication and creation, maintenance, and drive of timelines to keep consultations, studies and projects on schedule; this includes overall project planning, but also specific deliverables during medical affairs initiatives.
Coordinate activities with project managers from other functions around resources, timelines, and deliverables as applicable.
Partner with finance and the medical affairs team to establish study budget templates and coordinate efforts for and provide guidance on monthly/quarterly/annual/LRP forecasting and budget activities including purchase orders and accounts payable.
Schedule, organize, and drive team meeting(s), prepare and distribute agendas, minutes, and maintain action and decision and risk logs.
Establish and maintain cross-functionally integrated project plans/timelines and accurately track and provide timely reporting on progress.
Manage project plans for specific activities and deliverables within Medical Affairs cross-functionally, and with third party vendors.
Assist in identifying areas of improvement in process/policy, develop recommendation/plans to streamline and simply the US Medical Affairs operating model.
Oversee and ensure tracking and movement with Medical Affairs SOPs and work with Quality to track compliance issues to completion.
Ensure the appropriate development and tracking of metrics across for US Medical Affairs.

Experience Required

5-8 years of experience in a project management role with at least 5 years of direct experience in medical affairs operations or skills adjacent.
Demonstrated in depth knowledge and experience in planning, management, and oversight of activities and deliverables, preferably within Medical Affairs.
Strong knowledge of and ability to implement Medical Affairs concepts and operational practices.
Proven experience with successful management and interaction with medical affairs vendors.
Proven track record of managing multiple projects and/or programs concurrently.
Deep knowledge and ability to use project management software and tools, as well as Smartsheet.
Ability to effectively represent Medical Affairs project management activities with a broader Project Management team and at the cross-functional team level.
Experience in strategic planning and execution and developing and implementing processes, including process improvement, and procedures.
Ability to design, implement and lead multiple projects, setting deadlines, assigning responsibilities, and monitoring progress towards goals.
Strong analytical and problem-solving skills, with a focus on planning, prioritization and organization to advance execution and deliverables.
Excellent interpersonal and communication skills (communication, writing and presentation skills).

Education

Bachelor’s Degree required, MBA, master’s degree or project management certification preferred.

Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.