Chiesi Farmaceutici S.p.A.
Ad Promo Manager, Americas Regulatory Affairs, Rare Diseases
Chiesi Farmaceutici S.p.A., Cary, North Carolina, United States, 27518
Ad Promo Manager, Americas Regulatory Affairs, Rare Diseases
Date: Jul 9, 2024Department: GRD Regulatory AffairsJob Type: Direct EmployeeTeam: R&D, Pharmacovigilance & Regulatory AffairsContract Type: PermanentLocation: Cary, NC, USAbout usBased 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
CAR E (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 USAChiesi 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 offerChiesi 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.”Purpose
Responsible for the regulatory review and submission of advertising and promotional materials for multiple Chiesi Global Rare Disease products in the United States. This position is also responsible for providing input to risk management activities, working in 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.Main Responsibilities
Promotional Material/External Communications Responsibilities:
Work in the Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, with additional duties in Canada.Manage and oversee the submission of promotional labeling materials and supporting documentation to regulatory agencies in accordance with submission requirements.Facilitate review meetings online and offline coordination with authors, reviewers/approvers to get content approved to support business needs.Ensures regulatory compliance while effectively managing business risks.Understands global promotional strategies and provides solutions to local US regulatory promotional issues.Maintains awareness of competitive activities by monitoring assigned rare disease therapeutic areas, modalities, competitor products promotional activities, and prepares complaint letters to OPDP as needed.Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled, and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings.Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.Actively contributes to the development and implementation of regulatory training programs for cross-functional partners.
Labeling Responsibilities:
Develop and maintain current knowledge of regulation of labeling and industry standards for labeling and communicate requirements to others as needed.Ensures appropriate implementation of Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation, launch prep, review, approval, and submission.Manage the labeling control process for tracking, implementation and regulatory submission of changes to new or existing labeling.
Provide input to risk management activities within Chiesi and work with other departments to ensure product risks are appropriately communicated.Provide training to Regulatory Affairs and other departments as appropriate.Review and provide input and communicate externally on regulatory guidance documents that impact US activities related to Regulatory activities.Interact with senior management, external departments and regulatory authorities as needed in the activities of GRDRA.Experience Required
Minimum 5 years Pharmaceutical/Biotechnology industry experience, at least 3 years Regulatory Affairs and advertising and promotion review and approval experience with marketed prescription drugs. 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.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.Education
Bachelor's degree in life sciences or related field required.Advanced degree and/or Regulatory Affairs Certification (RAC) credential a plus.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.
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Date: Jul 9, 2024Department: GRD Regulatory AffairsJob Type: Direct EmployeeTeam: R&D, Pharmacovigilance & Regulatory AffairsContract Type: PermanentLocation: Cary, NC, USAbout usBased 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
CAR E (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 USAChiesi 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 offerChiesi 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.”Purpose
Responsible for the regulatory review and submission of advertising and promotional materials for multiple Chiesi Global Rare Disease products in the United States. This position is also responsible for providing input to risk management activities, working in 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.Main Responsibilities
Promotional Material/External Communications Responsibilities:
Work in the Global Rare Diseases, Regulatory Affairs Ad Promo function for the United States, with additional duties in Canada.Manage and oversee the submission of promotional labeling materials and supporting documentation to regulatory agencies in accordance with submission requirements.Facilitate review meetings online and offline coordination with authors, reviewers/approvers to get content approved to support business needs.Ensures regulatory compliance while effectively managing business risks.Understands global promotional strategies and provides solutions to local US regulatory promotional issues.Maintains awareness of competitive activities by monitoring assigned rare disease therapeutic areas, modalities, competitor products promotional activities, and prepares complaint letters to OPDP as needed.Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled, and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings.Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.Actively contributes to the development and implementation of regulatory training programs for cross-functional partners.
Labeling Responsibilities:
Develop and maintain current knowledge of regulation of labeling and industry standards for labeling and communicate requirements to others as needed.Ensures appropriate implementation of Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation, launch prep, review, approval, and submission.Manage the labeling control process for tracking, implementation and regulatory submission of changes to new or existing labeling.
Provide input to risk management activities within Chiesi and work with other departments to ensure product risks are appropriately communicated.Provide training to Regulatory Affairs and other departments as appropriate.Review and provide input and communicate externally on regulatory guidance documents that impact US activities related to Regulatory activities.Interact with senior management, external departments and regulatory authorities as needed in the activities of GRDRA.Experience Required
Minimum 5 years Pharmaceutical/Biotechnology industry experience, at least 3 years Regulatory Affairs and advertising and promotion review and approval experience with marketed prescription drugs. 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.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.Education
Bachelor's degree in life sciences or related field required.Advanced degree and/or Regulatory Affairs Certification (RAC) credential a plus.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.
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