Team Lead Regulatory Translations
Team Lead Regulatory Translations
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Job Description
Job Description Summary
Oversees the provision of timely highquality regulatory translations essential for product registration maintenance and launches worldwide.Job Description
Key Requirements
Team leadership and strategic guidance
- Provides strategic guidance to a team composed of 56 direct reports and vendors in alignment with regulatory strategies. Previous Vendor Management with CROs 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 stateoftheart technologies to accelerate highquality 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
Decisionmaking and standard practices
- Strategizes oversees and supervisesRegulatory Translation Solution group working practices business guidance scopeofservices 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 masters 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 CROs 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 to Diversity & Inclusion:
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
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Clinical Trials CrossFunctional Teams DetailOriented Drug Development Lifesciences Negotiation Skills Problem Solving Skills Regulatory Compliance Risk ManagementEmployment Type
Full-Time
