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At Argenta, we’re more than a company — we’re a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it. Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market. We’re in a unique position. We are the world’s only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated to animal health. With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let’s Make It Happen, Together. The Americas CRO team is looking for motivated, driven individuals who thrive in their ability to multitask and work as a team! Argenta, Americas CRO is currently looking for a Senior Product Development Manager to join our team. Argenta has strongly embedded company values which is key to who we are and how we deliver. We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued. At Argenta we are a hard-working group who really enjoy the people we work with each day. That is why we support our people through strong culture, great benefits, and opportunity for growth. This role is subject to a DEA background check as well as a pre-employment drug screen and/or physical.
Job Responsibility:
Supports the Americas CRO business (regulatory to pre-clinical to clinical service) needs of Argenta Molecule to Market, and Risk/Mitigation plans
Effectively manage the product development requirements (pre-clinical and clinical projects) of internal and external projects
Demonstrates an awareness of current regulations, guidance's, and the animal drug development process, while maintaining a flexible and creative mindset to work through product development challenges
Contribute to the development of business strategies to increase profitability and grow the business to create value
Manage development projects or key development project areas from initial conversations to live-phase study activities to close-out / final study report signatures to tracking overall timelines and budgets for study activities
Coordinates selection of the vendor(s) for study protocol conduct &/or laboratory requirements and activities including the provision of necessary supplies required by the study protocol
Provides oversight to ensure tasks are completed correctly and on time (i.e. oversight in the tracking of adverse events (AEs) encountered in the study and ensures that all serious AEs and non-serious AEs are communicated appropriately to the Sponsor)
Coordinates the creation of materials and documentation for the study, and QA resources, as required
Directs and provides oversight of investigational veterinary product/control product inventory, accountability, labelling, regulatory documentation/notifications, and shipment of drug supplies to/from the Sponsor and study sites
Requirements:
10+ years or greater in veterinary drug development
Clinical Research Associate experience or equivalent experience and training
Experience and skills necessary to monitor a study
Results oriented. Defines and plans priorities well
Effectively manage client and stakeholder expectations through relevant communication
Comfortable balancing shifting priorities as required to meet business needs
A collaborative working style to be able to lead and motivate people at all levels and across all functions in an organization
Strong analytical thinking and problem-solving skills
Capable of working in a changing environment and under pressure
Effectively present information and concepts, in both written and oral formats clearly and concisely
Actively listens to ensure understanding
Computer proficiency including Outlook & Microsoft Suite and various assigned database platforms and electronic meeting applications
Express facts and ideas in writing in a clear, concise, convincing, and organized manner