Summary

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 execution of 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, and operate according to 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 the strategic 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.Work 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 delivery of quality publications on time and within budget. Manage specific publication project budget and contracts.Act as a role model for Takeda´s values

Education

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

Experience and Knowledge

6+ years’ experience in the medical communications or 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)Understanding of the pharmaceutical drug development process, clinical trial design and execution, statistical methods and clinical trial data reporting requirementsKnowledge of the scientific publication planning processes, good publication practice (GPP3), other publication-related guidelines (ICMJE, COPE) and of scientific reporting standards for studies (CONSORT, STROBE, PRISMA, etc..)Experience and knowledge of publication management software/systemsExperience leading cross-functional and global/local teamsExperience in vendor management

Other Skills

Excellent communication, written and presentation skillsStrong analytical and problem-solving skillsAbility to synthesize, present, interpret and discuss complex medical and scientific dataStrong team spirit and assertiveness, with good interpersonal and negotiation skillsScientific expertise in the disease/therapeutic areaAbility to work independently and under pressure