Lead Medical Writer, Publications

Position Summary

The Lead Medical Writer will work on publications (manuscripts, abstracts, posters, presentations) as assigned for an Immunology TA to support peer-reviewed publications and congress submissions to communicate data from company-sponsored clinical trials and observational studies.

Major Duties & Responsibilities

• Collaborate with Janssen global stake holders, authors, and steering committee members throughout the publication development process. May collaborate with external vendors on projects. Manage correspondence with journal editors and other personnel.
• Provide writing support for assigned documents and/or teams. Documents assigned may include but are not limited to abstracts, posters, and manuscripts. May assist with electronic submissions of manuscripts and/or abstracts.
• Write, edit, and revise manuscripts as well as abstracts, posters, and/or presentations. As agreed upon by authors, develop any or all of the following: manuscript outline, manuscript shell, draft manuscripts, as well as other sections of publications.
• Manage working group meetings and collaborate with authors to advance the development of abstracts/posters/manuscripts.
• Lead mock-up development of data displays (e.g., tables and figures). Review and interpret data and source documents for information required for document development.
• Identify and resolve, with the help of other functional areas, clinical and statistical issues in the interpretation of clinical data.
• Conduct detailed literature reviews for topics of interest related to project documents using various search engines.
• Demonstrate mastery of relevant publication and regulatory document guidance, including but not limited to International Committee of Medical Journal Editors (ICJME), Good Publication Practices (GPP), Consort Guidelines, American Medical Association (AMA) Manual of Style, Council of Biology Editors, as well as ICH and other regulatory guidelines pertaining to study protocols and clinical study reports.
• May perform other duties as assigned.

Required Minimum Education: Bachelor’s degree or equivalent is required. Masters, PhD, PharmD desirable.

Required Years of Related Experience: Minimum of 5 years of experience in the pharmaceutical publications

Please see attached for more information on the Lead Medical Writer position