Job Description
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Summary Oversees the provision of timely, high-quality regulatory translations essential for product registration, maintenance, and launches worldwide. About the Role
Key Requirements
Team leadership and strategic guidance
* Provides strategic guidance to a team composed of 5-6 direct reports and vendors, in alignment with regulatory strategies. Previous Vendor Management with CRO's is a must.
* Ensures the selection of qualified talent (team members and vendors) to meet regulatory translation demands.
Compliance and implementation
* Ensures compliance excellence in collaboration with Process Transformation & Learning.
* Implements state-of-the-art technologies to accelerate high-quality translations and facilitate submissions as necessary.
* Updates vendors' or service providers' Statements of Work (SoWs) and supervises the team budget as required.
* Has global financial competence over team activities
Decision-making and standard practices
* Strategizes, oversees and supervises Regulatory Translation Solution group working practices, business guidance, scope-of-services, vendors' guidance, maintenance of terminological term bases, and the provision of relevant trainings to COs regarding Regulatory Translation Solution group processes as necessary.
* Serves as the Subject Matter Expert (SME) for working practices and/or Standard Operating Procedures involving regulatory translations.
Stakeholder communication
* Maintains clear and regular communication channels with key stakeholders.
* Represents the Regulatory Translation Solution group in leadership meetings as required and maintains clear and regular communication channels with key stakeholders.
This role will be hybrid, requiring 3 days per week in our London office.
Your Experience
* A university degree in a bioscience (e.g., biology, medicine, pharmacy, or biochemistry) or extensive experience in medical/pharmaceutical translation.
* A master's or PhD in molecular biology or biochemistry is especially preferred.
* Fluency in English (both written and spoken). Proficiency in other languages, is desirable but not essential
* Ideally must have around 8 years + experience. Project Management, vendor management with CROs & translations. This will require you to be customer oriented with strong communication skills
* Leadership experience combined with excellent communication skills, team building and performance driven compliance.
* Working knowledge of Regulatory Affairs in the Pharmaceutical industry or with CRO's is desirable.
* Forward thinker with the ability to embrace new technologies & be tech savvy, experience with Veeva Volt would be nice to have.
* Strong compliance mindset
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team's representative of the patients and communities we serve.
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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