Takeda - Head of Medical Writing, Vaccines, based in Zurich, Switzerland.
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as
Head of Medical Writing for our Vaccines Business Unit, based in Zurich.
Here, you will be a vital contributor to our inspiring, bold mission.
The Senior Director, Medical Writing is responsible for providing leadership and expertise necessary to develop and execute the overall strategy of the Global Development Medical Writing function. This position is responsible for strategically planning and resourcing the medical writing deliverables that support Takeda’s business objectives for clinical & regulatory development for Vaccines Business Unit with multiple compounds through all phases of development.
This position drives standardization while providing critical expertise to support functional and global clinical vaccine program requirements and serves as a senior strategic Medical Writing resource to clinical development teams for its vaccine development activities.
He/She is responsible for Medical Writing global submission timelines/planning/forecasting and budget management (administrative budget and for direct reports) for assigned therapeutic area.
- Provide strategic direction and leadership to the global medical writing function including external headcount and CROs
- Targeted alignment with VBU Japan for document standards and global program and submission document requirements
- Serve as global decision-maker for the medical writing function including representative in interactions with functions within VBU clinical development (e.g., clinical teams, regulatory affairs, development delivery, discovery), outside Clinical Development (e.g., global medical affairs) and external vendors
- Ensure reliable execution and delivery (quality, cost and time) of clinical documents to support global program and submission requirements
- Set performance standards
- Oversight of document authoring and publishing plans and execution
- Ongoing monitoring of issues/risks and remediation measures
- Ownership of all Clinical Development document standards/templates such as protocols and clinical study reports
- Liaison with global clinical trial disclosure activities and team to ensure compliance with all regulatory and Takeda requirements associated with clinical trial posting and results disclosure
- Develop and implement an efficient operating model for the global medical writing function including outsourcing strategy, operating processes, enabling technologies, staffing model, roles and responsibilities
- Efficiently leverage external vendor resources while retaining sponsor oversight for performance and quality
- Ensure compliance with all applicable internal policies and procedures, GCPs, and all applicable regulations; ensure inspection readiness of all regulated activities
- Minimum BS degree in life science, English or other applicable scientific degree with MS, PhD or MD preferred
- Significant previous experience leading the medical writing activities for major global submissions
- Scientific and medical experience/expertise sufficient to understand and be conversant on key issues in relevant therapeutic areas.
- Experience operating in a multi-disciplinary drug development environment, including international exposure and experience in a variety of therapeutic areas
- Experience working within a complex organization and demonstrated ability to work across functions and regions, at all levels without direct authority
- Strong leadership capability with advanced skills in team building, motivating, and developing people
- Proven success in effectively managing external vendors / resources
- Advanced knowledge of ICH guidelines, and local regulatory requirements and processes as related to document content, organization, format, and production.
- Ability to assess issues/risks and effectively implement remediation measures
- Experience with global regulations and global regulatory inspections
- Understanding of clinical trial information management and publishing technologies
- Ability to comprehend and synthesize complex data, identify issues and trends and develop and implement solutions/plans
- Strong proven ability to manage large and complex global change agendas
- Ability to influence and work effectively with various business partnerships, regions, and cultures
- Excellent communicator with strong written and verbal presentation skills.
WHAT TAKEDA CAN OFFER YOU
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering Our People to Shine
At our heart are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, race or ethnic origin or disability. Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?
Email applications to Hasan Bousnak: firstname.lastname@example.org