Lead team of 8-10 employees in delivering high-quality non-clinical documentation, ensuring robust regulatory submissions that support Takeda R&D programs across therapeutic areas
Oversee and ensure compliance with internal policies, GxP standards, and regulatory requirements, promoting inspection readiness for all regulated activities
Develop and adapt operating models, standards, and strategies to optimize documentation quality, process efficiency, and pipeline acceleration
Build and sustain collaborative partnerships with direct stakeholder groups (NCSP, DMPK&M, DDUs, TAUs) and drive process improvements across Research functions
Offer strategic direction on enabling technologies, staffing models, and external resource usage, ensuring capacity and scalability during increased workload periods
Create and maintain a culture of delivery excellence, inspiring team members and optimizing group performance to meet organizational objectives
Manage staffing, recruitment, training, mentoring, and performance evaluation processes to sustain a highly effective team
Ensure efficient electronic library management
Lead continuous improvement initiatives to enhance process optimization, non-clinical documentation standards, and portfolio timeline delivery within Takeda Research
Qualifications
Minimum 10 (or 15) years’ experience in medical writing within a pharmaceutical or Contract Research Organization (CRO)
Minimum 5 years’ experience leading teams
Advanced degree related to pharmacology, toxicology, or pharmacokinetics, or other related scientific discipline preferred
Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics, demonstrating a broad understanding of the drug development process
Strong leadership capability with advanced skills in team building, motivating, and developing people
Ability to influence and work effectively with various business partnerships, regions, and cultures
Demonstrated ability to prioritize, manage multiple programs within strict regulatory and compliance deadlines, and lead internal/external and scientific teams to regulatory submission aims
Thorough understanding of regulatory guidelines related to global submissions and submission content (e.g., FDA/EMA/PMDA regulations; ICH guidance and familiarity with GLP/GCP requirements)
Demonstrated critical thinking skills and strong attention to details.
Thrives in an agile and high-pace environment
Ability to comprehend and synthesize complex data, identify issues and trends and develop and implement solutions
Excellent communicator with strong written and verbal presentation skills
