Job Type :
Required Years of Experience :
Required Education :
Job Industry :
Job Category :
Pharmaceutical Operational Support
Job Description :
In this role, the Medical Writer will work on publications (e.g. manuscripts, abstracts, posters, presentations, and slide decks) as assigned, to support peer-reviewed publications and congress submissions of data from our company-sponsored clinical and observational studies.
- Collaborate with Janssen global partners, authors, and steering committee members throughout the publication development process. May collaborate with external vendors on projects. Handle correspondence with congress organizers and other personnel.
- Provide writing support for assigned documents and/or teams. Documents assigned may include manuscripts, abstracts, posters, and slide decks. Assist with electronic submissions to journals and congresses.
- Write, edit, and revise manuscripts, abstracts, posters, and/or presentations. As agreed upon by authors, develop any or all of the following: manuscript/abstract/poster/presentation outline and drafts
- Lead working group meetings and collaborate with authors to advance the development of manuscripts/abstracts/posters/presentations.
- 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 proficiency in 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.
- Handle document development timelines to facilitate timely submission.
Required Qualifications :
- A minimum of a Bachelor’s degree is required.
- Masters, PhD, or PharmD is preferred.
Experience and Skills:
- A minimum of 5 years of relevant publication writing experience in the pharmaceutical industry is required.
- Familiarity with relevant publication, industry, and regulatory document standards is required
- Ability to learn and recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in document types under supervision is required
- Strong oral and written communication skills
- Leadership skills, both in time management as well as in project/process management
- Able to resolve basic problems independently and complex problems under supervision.
- Learning agility and attention to detail
- Able to build solid and positive relationships with cross-functional team members.
- ISMPP CMPP or AMWA MWC certification