Director, Medical Publications – Medical Affairs

The Director Publications Lead is a key strategic partner of the Medical Affairs teams responsible for dynamically driving the strategic planning and tactical execution of the comprehensive publication plan.

• Own and lead the Scientific Publications Team meeting and workshops to drive the development of the strategic global publication plan (inclusive of clinical, PK/PD, HEOR, Biomarker, preclinical publications) for the assigned programs with the ability to lead and collaborate effectively across numerous and diverse internal and external stakeholders
• Provide writing and editorial support for clinical and disease state abstracts, posters, manuscripts, and other publications, including conducting literature searches and preparing annotated summaries for internal teams.
• Ensure and communicate regular updates to relevant key stakeholders to facilitate ongoing functional and regional planning and inform dependencies
• Ensure that all 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 the deliverables and in the use of external vendors
• Ensure that vendors are properly trained to and comply with company 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 Lead special projects with team and Med Affairs depts (eg team onsite meeting agenda)
• Lead special projects with team and Med Affairs depts (eg team onsite meeting agenda).

1. Ability to collaborate with external authors and journals for the planning, integration, and execution of all publication activities
2. Have deep subject matter expertise on innovative and compliant publication strategies, tactics and policies
3. Provide and lead high level strategic thinking for innovative strategies in developing and disseminating scientific and medical data, including the integration of AI-enabled tools and digital platforms to enhance publication planning, data dissemination, and stakeholder engagement.
4. Exceptional scientific writing, storytelling, and communication skills.
5. Strong organizational and project management capabilities; able to manage multiple priorities and operate independently and manage budget effectively.
6. Demonstrates intellectual agility, problem-solving skills.
7. Ability to manage external vendors and provide clear, concise direction.
8. Excellent written and verbal communication skills, with the ability to understand and effectively communicate complex scientific and clinical data to internal and external stakeholders.
9. Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
10. Manage budget, forecasting, and resource allocation plan by developing materials to track team expenditures.
11. Contribute to the development and facilitate cross-functional discussions to identify gaps and opportunities to evolve the publication plan.
12. Manage processes, and activities focusing on quality and timeliness with an eye for efficiency.
13. Accurate and timely reporting of post-publications metrics, compliant maintenance of records.

• 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
• Prior experience in hypertension, chronic kidney disease, and/or sleep apnea
• 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 matrix
• Demonstrated ability to formalize governance structures and develop operational processes and SOPs.
• Experience in vendor and budget management