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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."
Responsible for the regulatory review and submission of advertising and promotional materials for all Chiesi Global Rare Disease products in the United States. This position is also responsible for providing input to risk management activities, managing the labeling control process, including generation of new labeling and changes to existing labeling, and submission of labeling information to regulatory authorities in the United States and Canada.
Promotional Material/External Communications Responsibilities:
Labeling Responsibilities:
Risk Management Responsibilities:
* Advanced degree and/or Regulatory Affairs Certification (RAC) credential required.
* Minimum 8 years Pharmaceutical/Biotechnology industry experience, at least 5 years Regulatory Affairs and advertising and promotion review and approval experience with marketed prescription drugs. Direct experience with rare disease drug development a plus.
* Excellent understanding of US regulations for drug promotion/advertising and US labeling, and experience interacting with FDA OPDP
* Experience with Veeva Vault PromoMats and MedComms, Trackwise, or similar document management systems a plus
* Demonstrated expertise in regulatory requirements for labeling and advertising materials. Experience in reading, interpreting, and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance. Knowledge of Common Technical Document and global guidelines on content and format of labeling preferred.
* Familiarity in the drug development process and prior experience in preparation of original submissions for new drugs preferred. Experience with creating and reviewing labeling and advertising materials required.
* Experience on collaborative multifunctional work teams at the local or global level.
* Ability to manage multiple tasks and multifunctional resources concurrently, and to respond to rapidly changing priorities and aggressive deadlines.
* Experience in communicating with all levels of personnel, in local and global environments.
* Shared philosophy with Global Rare Diseases, acknowledging that patients and their caregivers are the central driving force behind all initiatives.
* Bachelor's degree in life sciences or related field required.
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.
Full Time
Wholesale
$82k-108k (estimate)
03/02/2024
05/01/2024
chiesi-limited.com
MANCHESTER
200 - 500
1987
THOMAS JOSEPH DELAHOYDE
$200M - $500M
Wholesale