Director, Global Publications Lead, Gastroenterology

About USDM USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally. As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences? Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany. Nature and Scope of Job The Director, Global Publications Lead, Gastroenterology, is a key strategic partner of the Gastroenterology and Immunology Medical Affairs teams, responsible for dynamically driving the strategic planning and tactical execution of the comprehensive publication plan. Primary Responsibilities • In partnership with cross-functional stakeholders, the Global Publications Lead, Gastroenterology will: • Own and lead the Scientific Publications Team meeting and annual workshops to drive the • development of the strategic global publication plan for the assigned programs with the ability • to lead and collaborate effectively across numerous and diverse internal and external • stakeholders • Provide and lead high level strategic thinking for innovative strategies in developing and • disseminating Takeda’s scientific and medical data at the Global level, including the integration • of AI-enabled tools and digital platforms to enhance publication planning, data dissemination, • and stakeholder engagement. • Ensure and communicate regular updates to relevant key stakeholders to facilitate ongoing • functional and regional planning and inform dependencies • Collaborate with external authors and journals for the planning, integration, and execution of • all publication activities • Create a spirit of cooperation and collaboration and foster diversity of opinion and an • environment of psychological safety and open communication in the establishment and • execution of annual program strategies, objectives, tactics and priorities • Bring deep subject matter expertise on innovative and compliant publication strategies, tactics • and policies • Ensure that all of client’s publication related activities are conducted according to • standards, SOPs, applicable working instructions and, industry standards and educate on these • policies as necessary • Ensure high scientific quality, alignment with medical strategy and adherence to • compliance/legal requirements • Manage 3rd-party vendors to ensure delivery of quality publications on time and on budget • Utilize and champion the use of AI and digital technologies to optimize publication workflows • and processes, including applications in literature review, plain language summary creation, • and innovative approaches to data synthesis and visualization. • Create, review and oversee the publication budget and serve as a financial steward in the • creation of publication deliverable approaches and in the use of external vendors • Ensure that vendors are properly trained to and comply with client’s standards, on SOPs, • company systems and tools while managing all vendor partners to execute the tactical plan • effectively and efficiently for their assigned publication projects Additional Responsibilities • Performs other related duties and assignments as required Qualifications • Prior experience in immune-mediated inflammatory diseases is preferred, especially in psoriasis • or Gastroenterology • Demonstrated experience in leveraging AI tools and/or digital technologies in scientific • communications and publication planning. • Understanding of the pharmaceutical drug development process, clinical trial design and • execution, statistical methods, and clinical trial data reporting requirements. • Deep knowledge of scientific publication planning processes and industry standards for • reporting scientific studies including but not limited to GPP, ICMJE, COPE, CONSORT, STROBE, • PRISMA • Experience and knowledge of publication management software/systems • Ability to foster diversity of opinion and an environment of open communication and trust • Demonstrated ability in coordinating and implementing simultaneous projects within a complex • global matrix and align region and country-specific priorities into a unified approach that meets • multiple stakeholder needs • Proactive, enterprise thinker with multicultural outlook, and the ability to work effectively in a • geographically and functionally diverse organization. • Experience in vendor and budget management Education & Certifications • A higher education degree (M.D., Pharm.D., Ph.D.), or master’s degree in biomedical discipline or equivalent with demonstrated experience in publication management • 8-10+ years of pharmaceutical industry experience, at least half of which is in Medical Affairs • 5-8+ years’ experience in medical publications/communications, or other related areas within the biopharmaceutical industry, preferably within a matrix structure, in Medical Affairs or Clinical Development (e.g. clinical scientist, medical information, medical communications, medical information, publications). • CMPP certification preferred Working Conditions The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job. Unless reasonable accommodations can be made, while performing this job the staff member shall: • Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment. • Operate other office productivity machinery, such as a calculator, scanner, or printer. • Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations. Equal Opportunity Statement USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Disclaimer This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Compensation Salary/Hourly Rate Range (W2): USD 100.00 - 120.00 The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget. Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage. Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off. All employees are eligible for USDM's rewards and recognition program. For more details about our benefits, visit us here: https://usdm.com/careers