Title:Head of Medical Writing
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Title in our Boston office.
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 Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- Strategic direction, planning and resourcing of medical writing activities
- Regulatory submissions, development, approval, implementation, compliance of medical writing processes, standards, style guidelines, templates
- Oversight of external vendors
- Protocol, CSR, IB writing for key programs and studies
- For Clinical Editing, Publishing overall responsibility for:
- Editing, publishing support and quality assurance
- Provide strategic direction, planning and resourcing of medical writing activities
- Targeted alignment with TDC 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 R+D (e.g., clinical science, regulatory affairs, clinical operations, analytical science), outside R+D(e.g., 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 R+D 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
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- 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 (Oncology, GI, Neuroscience, Rare Diseases, PDT and others)
- 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.
- Experience with global regulations and global regulatory inspections
- Understanding of clinical trial information management and publishing technologies
- Senior management experience in Clinical Data Management or related field, leading a medium to large organization and influencing senior-level management and key stakeholders
- Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
- Operational experience in pharmaceutical drug development with significant direct exposure to clinical development
- Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.