Manager, Scientific Affairs
Manager, Scientific Affairs
Perrigo
Dublin, Ireland
Description Overview
This role focuses on substantiation and management of safety and health benefit claims for new and established brands and products within the CSCI OTC organisation. The Scientific Affairs Manager leads on proving efficacy to drive competitive claims throughout product lifecycle and partners with Product Developers to develop superior products. He/she communicates internally and externally to our Regulators, Health Care Professionals, Key Opinion Leaders, Customers and Consumers to drive acceptance, awareness, and recommendation. The role is highly driven by consumer-centricity.
Scope of the Role
- Lead identification and substantiation of health benefit claims, with an understanding of appropriate terminology and language;
- Work closely with Product Development, Marketing and Regulatory colleagues to ensure a consolidated understanding of product MoA and ensure all claim options are explored;
- Lead design of preclinical and/or clinical studies needed to support health benefit claims;
- Collaborate closely with Clinical Operations during study management;
- Provide project-level expertise, working with Marketing, Formulation, Product Development, Packaging, Project Management, Regulatory and Consumer Insight functions internally, and with external partners, according to applicable regulations and guidance, ICH-GCP and Perrigo SOPs;
- Author, update and maintain relevant scientific documentation;
- Communicate internally and externally to drive acceptance, awareness and recommendation of consumer self-care products;
- Contribute to the development of in-house Scientific Affairs expertise to ensure high quality, credible and relevant data is generated to support new/existing products, support publication of this data, and KOL management when appropriate;
- Landscape surveying for new trends & emerging technologies.
Experience Required
- Postgraduate degree in life sciences (PhD preferred);
- Typically 5+years’ experience in scientific affairs and clinical development;
- Experience in preclinical and clinical development of medical devices and medicines, especially smoking cessation, is highly desired, alongside a proven track record in study design methodology and claims management;
- Applicants should have strong communication and stakeholder management skills.
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