Publication Lead, Rare Genetic Diseases
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Publication Lead, Rare Genetic DiseasesApply Now
OBJECTIVES/PURPOSE: (3-4 bullets)
The Global Publication Manager is a key strategic partner of the Global Medical Affairs team who develop and implement the strategic global publication planning for the assigned programs within the therapy area. The Publication Manager works in close collaboration with key stakeholders in clinical development, global medical affairs, global outcomes research & epidemiology (GORE), and medical communications to ensure its alignment with the R&D and medical plans.
The Publication Manager will provide strategic thinking for innovative strategies in developing and disseminating Takeda’s scientific and medical data. Responsibilities also include the development and execution of the global (all regions) publication plan for the assigned programs (early or late stage development). The successful individual will have cross-functional experience and the ability to collaborate effectively with scientific and healthcare professionals.
The Publication Manager has subject matter expertise in industry publication practices and will be responsible to ensure Takeda standards/SOPs are implemented both with external stakeholders and internal cross-functional teams. The Publication Manager collaborates with the medical writing vendors in the execution of the tactical publication plan, and under the Publicaton Group Lead leadership ensures that vendors are properly trained on Takeda’s policies, procedures, tools and systems.
Develop, manage and execute the strategic product/disease area global publication plan in collaboration with key cross-functional team members (i.e. medical affairs, clinical, biostats, whether global, regional, local). Collaborate with global medical affairs, and regional medical leads to identify publication needs and align global publication plans across regions/countries where appropriate.
- Collaborate with external authors and journals for the planning, integration and execution of R&D publication activities.
- Ensure that all Takeda’s publication related activities are conducted according to Takeda’s standards, SOPs, and applicable working instructions, as well as to good publication practice guidelines (including but not limited to GPP3, ICMJE, CONSORT, etc…)
- Promote and support good publication practices and principles among authors and internal publication stakeholder community ensuring high scientific quality & alignment with compliance/legal requirements.
- Oversee 3rd-party vendors and independent contractors to ensure the timely delivery of quality publications. Under the leadership of the Publications Group Lead, ensure that vendors are properly trained to Takeda’s standards, on SOPs, company systems and tools. Manage all vendor partners to effectively and efficiently execute the tactical plan for their assigned publication projects.
- 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.
- Be a role model for Takeda´s values
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
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:
- 2+ years’ experience in the medical communications or biopharmaceutical industry, preferably within a matrix structure, preferably 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 requirements
- Knowledge 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/systems
- Experience leading cross-functional and global/local teams
- Experience in vendor management
- Excellent communication, written and presentation skills
- Ability to work independently and under pressure
- Strong team spirit and assertiveness, with good interpersonal and negotiation skills
- Ability to synthesize, present, interpret and discuss complex medical and scientific data
- Scientific expertise in the disease/therapeutic area
- CMPP certification (ISMPP) preferred
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Job ID SR0047688