As the subject matter expert on publication strategy, the Publications Lead defines and drives publication strategic plan based on medical strategies, publication obligations, and data availability and acts as consultant to the Global Medical Strategy Team. The Publications Lead understands how the publication activities contribute to the overall medical affairs communications plan for the assigned programs and therapeutic area; develops and implements strategic, compliant and fit-for-purpose publication plan for the Plasma-Derived Therapies; and collaborates with all levels of medical affairs (i.e., global, regional, local), medical publications agencies and external authors to ensure of execution the global publication plan.
- Ensure Takeda s company-sponsored publication activities are conducted according to good publication practices (including, but not limited to ICMJE, GPP3, CONSORT, etc) and Takeda s Global Publication Standard, SOP, and applicable practice guidelines. Track, and report publications metrics as required.
- Provide oversight of agencies partners to ensure appropriate execution of publication plans; ensure vendor partners are properly trained on Takeda Standards, SOPs, systems, and tools for appropriate and effective execution of responsibilities, including interactions with alliance partners, authors (internal and external), as well as company data-generators, and reviewers. Manage budget for assigned programs, including Project Work Orders, Change Orders, invoice approval and financial reconciliation process; closely coordinate budget reporting; responsible for appropriate tracking and reporting of transfer of value according to applicable transparency rules and regulations (e.g., US Sunshine Act).
- The assigned publication programs will be global, may be large and complex, and of business importance to Takeda and Takeda s reputation, requiring multi-functional leadership experience and skills to achieve program goals.
- Develop and manage product/disease area Global Publication Strategies and Plans in coordination with relevant Global Medical Teams. Work with GMA lead, and Regional Lead to align publication plans across geographies. Identify, select, and manage 3rd-party providers and independent contractors to ensure the timely delivery of quality publications. Manage specific publication project budget and contracts.
- Collaborate with societies, external authors and journals in planning, integration and execution of medical publication activities.
- Promote and support good publication practices and principles among authors and internal publication stakeholder community ensuring high scientific quality & alignment with Compliance/Legal requirements.
- Act as first point of contact for affiliate offices, internal business partners, and management on publication-related issues, including, but not limited to, vendor access, training, system issues, and good publication practices.
- Ensure and communicate regular updates to relevant key stakeholders to facilitate ongoing functional and regional planning and inform dependencies.
- Track Global Publications metrics and provide reports to Head of Publications as required. Manage vendor partners to effectively and efficiently execute the tactical plan for assigned publication programs according to Takeda Standards, SOPs, and related good publication practices guidelines Act as a role model for Takeda s values.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- A higher education degree (M.D., Pharm.D., Ph.D.) is preferred
- Master s degree in biomedical discipline or equivalent with experience in publication management is considered.
- Focus on accountability and ownership
- Strong communication, presentation, and written skills
- Strong attention to detail
- Strong relationship management skills
- Unquestionable ethics
- Understanding of good publication practices
- Scientific expertise in the disease/therapeutic area preferred
- Understanding of the clinical trial design and execution, statistical methods and clinical trial data reporting requirements
- Ability to work independently
- Fluent business English (oral and written)
- 6+ years in the medical communications or biopharmaceutical industry, biopharmaceutical industry, preferably within a matrix structure.
- 4+ years experience in Medical Affairs or Clinical Development (e.g. Clinical Scientist, Medical Information, Medical Communications, Publications, Post-Doctoral medical communications residency or fellowship)
- Experience and knowledge of clinical trial reports, data presentation, and interpretation
- Knowledge of scientific publication planning approaches is required
- Familiarity with regulatory and legal guidelines regarding publication planning strategy and execution
- Experience leading cross-functional and global teams
- CMPP certification is preferred
- May require approximately 20% travel, including overnight and international travel to conferences, other Takeda sites, strategic partners, and therapeutic area related travel.
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