OBJECTIVES: 

As the subject matter expert on industry and publication best practices and development of scientific publication strategy, the Publications Lead proactively defines and drives the publication strategic plan based on medical strategies, transparency requirements, and data availability and acts as consultant to key cross-functional teams (Clinical, Research, Medical Affairs, ORE) across geographies.The Publication Lead understands how the publication activities contribute to the overall transparency standards of reporting industry sponsored data and medical affairs communications plan for the assigned programs and therapeutic area; develops and implements strategic, compliant and fit-for-purpose publication plan; and collaborates with all levels of medical affairs and other key internal stakeholders (i.e., global, regional, local: Clinical, ORE, Biostats), 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. Strong leadership skills required for training internal teams on good publication practices and managing interactions with internal stakeholders, alliance partners, authors (internal and external), as well as company data-generators, and reviewers.Provide oversight of agency 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.Manage budget for assigned programs, 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.

ACCOUNTABILITIES: 

Proactively develop and manage product/disease area Global Publication Strategies and Plans in coordination with relevant cross-functional teams (Medical Affairs, Clinical, Biostats: global, regional, local). Work with Global Medical Affairs, and Regional Lead to align publication plans across geographies.Implement/apply industry reporting standards, publication standard reporting guidelines/checklists.Working with complex data across different areas (clinical, pre-clinical, ORE) to develop robust publication plan. Promote and support good publication practices and principles among authors and internal publication stakeholder community ensuring high scientific quality & alignment with Compliance/Legal requirements and industry standards.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.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 Manage 3rd-party providers and independent contractors to ensure the timely delivery of quality publications. Manage specific publication project budget and contracts.Act as a role model for Takeda´s values

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

Education: 

A higher education degree (M.D., Pharm.D., Ph.D.) is preferredMaster’s degree in biomedical discipline or equivalent with experience in publication management is considered.

Skills: 

Focus on accountability and ownershipStrong communication, presentation, and written skillsStrong attention to detailStrong relationship management skillsUnquestionable ethicsUnderstanding of good publication practicesScientific expertise in the disease/therapeutic area preferredUnderstanding of the clinical trial design and execution, statistical methods and clinical trial data reporting requirementsAbility to work independentlyFluent business English (oral and written)

Experience:

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 requiredFamiliarity with regulatory and legal guidelines regarding publication planning strategy and executionExperience leading cross-functional and global teams

LICENSES/CERTIFICATIONS:

   CMPP certification is preferred

TRAVEL REQUIREMENTS:

May require approximately 20% travel, including overnight and international travel to conferences, other Takeda sites, strategic partners, and therapeutic area related travel.