Medical Writing Lead - Vaccines
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
What makes a successful member of our team?
We take action and make decisions by focusing on our four priorities in this order:
Putting the patient
at the center
Life at Takeda
To keep delivering new value to patients, we provide growth opportunities for every employee according to their abilities and passions, and together are building a stronger organization.
Procurement Lead, Northern Europe
“Takeda is a unique place to work as there is no ‘every-day routine’ around here – it’s very a dynamic environment where change of plans and adjustments of approach are the constants... This allows for interesting cross-function collaboration and – if you’re up for it - a high degree of influence on your daily job and workplace.”
Regional Head, Europe, Vaccines
“Takeda is a great place to work as the company invests in the continuous development of its employees offering training, coaching, mentoring and open exchanges between all levels of the organization. Also, it is fulfilling to know that, within the Vaccine Business Unit, we are developing and delivering innovative vaccines impacting the lives of millions of people around the world.”
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
Medical Writing Lead - VaccinesApply Now
Medical Writing Lead - Vaccines
- Provide leadership and expertise necessary to develop and execute the overall strategy of the Clinical Development medical writing function
- Reliably and efficiently deliver clinical documents to support global clinical program and regulatory submission requirements
- Drive standardization while providing critical expertise to support functional and global clinical vaccine program requirements
- Establish global operating and quality standards and ensure ongoing performance against these standards
- 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 such as protocols and clinical study reports
- Lead global clinical trial disclosure activities 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
- Contribute to creating a culture and values that attracts, retains, and develops the most effective people
- 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
Job ID R0014879