Hybrid Associate Director, Global Medical Affairs – Publication Operations

at OneTrust

• Job title: Associate Director, Global Medical Affairs – Publication Operations
• Job type: Full Time
• Experience level: Senior
• Salary: $137,000 - $235,750 per year
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Raritan, United States

About the role

• Associate Director for Global Medical Affairs Publication Operations at Johnson & Johnson. Provide expert writing, editing, and compliance support for scientific publications.

Responsibilities

• provide expert reviewing, writing, and editing support to ensure timely production of high-quality documents (abstracts, posters, slide presentations, manuscripts, letters to editor, etc.) for publication in medical/scientific journals or presentation at medical/scientific meetings, and maintain compliance with all company policies/procedures and applicable industry standards/guidelines.
• 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.
• Assist 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.
• For encore abstracts/posters/oral presentations, partners with relevant stakeholders (e.g., GMAL, SEL, SCL, authors, writers) to efficiently deliver assigned encores.

Requirements

• A PhD, PharmD, MD or equivalent degree with a minimum of 8 years of relevant pharmaceutical/scientific experience is required OR a Master’s (or other advanced degree) with a minimum of 10 years relevant pharmaceutical/scientific experience is required.
• 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 is preferred.
• Demonstrated ability to interpret and organize scientific data is required.
• The ability to work well independently and as part of a team is required.
• Project management experience is preferred.
• The ability to stay organized, manage time, and work on multiple documents/projects at once is required.
• Knowledge across several therapeutic areas such as oncology, neuroscience, and immunology is preferred.
• Experience with medical writing document standards and processes is preferred.
• Experience using workflow management tool (e.g., JPUBS, Datavision, or PubSTRAT) is preferred.
• CMPP certification is preferred.
• Up to 10% travel.

Benefits

• medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• participation in the Company’s long-term incentive program.
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year.
• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year