Role Summary
Director of Publications within Medical Affairs. This role leads Medical Affairs Publications, shaping development, management, and dissemination of publication plans to support hypertension, chronic kidney disease, and sleep apnea. The position involves strategic leadership of cross-functional publication teams and execution of clinical and disease-state publications in a fully remote environment.
Responsibilities
- Own and lead the Scientific Publications Team meetings and workshops to drive development of the strategic global publication plan across clinical, PK/PD, HEOR, biomarker, and preclinical publications for assigned programs, collaborating with internal and external stakeholders
- Provide writing and editorial support for clinical and disease-state abstracts, posters, manuscripts, and other publications, including literature searches and annotated summaries for internal teams
- Communicate regular updates to key stakeholders to facilitate ongoing planning and inform dependencies
- Ensure publication activities comply with standards, SOPs, working instructions, and industry standards; educate others on these policies as necessary
- Maintain high scientific quality, align with medical strategy, and ensure compliance with legal requirements
- Manage 3rd-party vendors to deliver quality publications on time and on budget
- Utilize AI and digital technologies to optimize publication workflows and processes (literature review, plain language summary creation, data synthesis and visualization)
- Oversee the publication budget and act as a financial steward in the creation of deliverables and vendor use
- Train vendors to comply with company standards, SOPs, and tools; manage vendor partners to execute tactical plans efficiently
- Lead special projects with the team and Medical Affairs departments (e.g., team onsite meeting agendas)
Qualifications
- Required: Higher education degree (M.D., Pharm.D., Ph.D.) or masterโs degree in biomedical discipline with demonstrated experience in publication management
- Required: 8โ10+ years of pharmaceutical industry experience, at least half in Medical Affairs
- Required: 5โ8+ yearsโ experience in medical publications/communications or related areas within biopharmaceuticals, preferably within a matrix structure, in Medical Affairs or Clinical Development
- Preferred: CMPP certification
- Preferred: Prior experience in hypertension, chronic kidney disease, and/or sleep apnea
- Preferred: Demonstrated experience leveraging AI tools and/or digital technologies in scientific communications and publication planning
- Required: Understanding of drug development, clinical trial design and execution, statistical methods, and trial data reporting requirements
- Required: Deep knowledge of scientific publication planning processes and industry standards (GPP, ICMJE, COPE, CONSORT, STROBE, PRISMA)
- Preferred: Experience with publication management software/systems
- Required: Ability to foster diverse opinions and open communication; coordinate multiple projects within a complex matrix
- Required: Ability to formalize governance structures and develop operational processes and SOPs
- Preferred: Experience in vendor and budget management
Skills
- Ability to collaborate with external authors and journals for planning, integration, and execution of publication activities
- Deep subject matter expertise on innovative and compliant publication strategies, tactics, and policies
- Strategic thinking for developing and disseminating scientific data, including AI-enabled tools and digital platforms
- Exceptional scientific writing, storytelling, and communication skills
- Strong organizational and project management capabilities; manage multiple priorities and budgets
- Intellectual agility and problem-solving skills
- Ability to manage external vendors with clear direction
- Excellent written and verbal communication for complex scientific data
- Highly organized with attention to detail, clarity, accuracy, and conciseness
- Budget forecasting and resource allocation; track team expenditures
- Facilitate cross-functional discussions to evolve the publication plan
- Focus on quality and timeliness of processes and activities
- Accurate and timely reporting of post-publications metrics and records
Education
- Higher education degree (M.D., Pharm.D., Ph.D.) or masterโs degree in biomedical discipline or equivalent with publication management experience
Additional Requirements
- Travel up to 20% of the time; overnight travel may be required, potentially international