Associate Director, Global Medical Affairs Publication Operations

About This Role

This role involves providing expert reviewing, writing, and editing support for high-quality medical/scientific documents for publication. The Associate Director ensures timely production and compliance with company policies and industry standards.

Responsibilities

• Responsible for scientific publication writing including abstracts, posters/oral presentations, and manuscripts, etc., and responsible for the overall production of publications and compliance with standard operating procedures/industry standards
• Familiar with the overall publication plan for product(s) and proactively fulfills Pub Ops’ role in generating assigned publications, including assigning medical writers and providing editing and project management to efficiently deliver high-quality publications to author teams
• Has extensive knowledge of medical/scientific journals and congresses for assigned products and therapeutic areas
• Partners with product team personnel (e.g., CDTL, GMAL, SEL, etc.) to advance publication-related goals of the team. May be involved with strategic/tactical planning for the submission and/or timing of publications
• Organizes kick-off meeting with authors for development of publication. Provides direction, oversight and editing for contract medical writers and junior-level medical writers
• Manage and/or review and interpret data and source documents for information required for publication
• Assists in table and figure mock-up development. Actively engage internal and external authors and other key stakeholders in the development of publication plans and strategy at the individual dataset, study, and/or compound level
• Participates as a member of Publication Teams and Product Teams, providing publication-related advice and input
• Serves as a Subject Matter Expert (SME) on J&J publication policies and procedures, including but not limited to J&J Publications SOP, JPUBS, and applicable industry standards including Good Publication Practice (GPP), International Committee of Medical Journal Editors (ICJME) recommendations, CONSORT Guidelines, American Medical Association (AMA) Manual of Style, and Council of Biology Editors, etc. Assists in developing or updating publication-related SOPs and Guidelines
• Participates in the development and maintenance of document templates, style guides, electronic document management and publication review and approval system

Requirements

• PhD, PharmD, MD or equivalent degree with a minimum of 8 years of relevant pharmaceutical/scientific experience OR Master’s (or other advanced degree) with a minimum of 10 years relevant pharmaceutical/scientific experience
• Demonstrated ability to interpret and organize scientific data
• Ability to work well independently and as part of a team
• Ability to stay organized, manage time, and work on multiple documents/projects at once

Qualifications

• PhD, PharmD, MD or equivalent degree OR Master’s (or other advanced degree)
• 8+ years of relevant pharmaceutical/scientific experience with PhD, PharmD, MD OR 10+ years with Master's degree

Nice to Have

• Research experience (including compilation of research reports or publications) in academia, the pharmaceutical industry, medical communication agency or as part of a PhD, PharmD or postdoctoral program
• Project management experience
• Knowledge across several therapeutic areas such as oncology, neuroscience, and immunology
• Experience with medical writing document standards and processes
• Experience using workflow management tool (e.g., JPUBS, Datavision, or PubSTRAT)

Skills

* Required skills

Benefits

Certifications