Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
We are recruiting for a Manager, Medical Writer to join the Scientific Communications team, supporting our Immunology therapeutic area. The writer will work on publications (e.g. manuscripts, abstracts, posters, presentations, and slide decks) as assigned, to support peer-reviewed publications and congress submissions communicating data from our company-sponsored clinical and observational studies.
Key Responsibilities
- Collaborate with Janssen global partners, authors, and steering committee members throughout the publication development process. May collaborate with external vendors on projects. Lead correspondence with congress organizers and other personnel.
- Provide writing support for assigned documents and/or teams. Documents assigned may include but are not limited to manuscripts, abstracts, posters, and slide decks. Assist with electronic submissions of manuscripts/abstracts/posters and presentations.
- 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.
- Run 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.
- Lead document development timelines to facilitate timely submission.
- Maintain annotated versions of documents and facilitate review cycles.
- Record/maintain project status using relevant tool(s).
- Shepherd documents through designated review and approval cycles.
- Facilitate, collate, and adjudicate author and reviewer comments.
- Adjudicate and address quality assurance review.
- Verify completion of required approvals.
- Lead projects review/approval in automated workflow system.
- Other duties as assigned.
Qualifcation
- Bachelor’s degree required. Master's degree, PhD, or PharmD preferred.
Experience and Skills
Required
- A minimum of 5 years of relevant publication writing experience in the pharmaceutical industry.
Preferred
- 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.
- Strong oral and written communication skills.
- Leadership skills, both in time management as well as in project/process management.
- Ability to resolve basic problems independently and sophisticated problems under supervision.
- Familiarity with relevant publication, industry, and regulatory document guidance and standard processes.
- Learning agility and attention to detail.
- Ability to build proven and positive relationships with cross-functional team members.
- Proficiency in Microsoft Word, Excel, Power Point, Microsoft Teams, SharePoint.
- ISMPP CMPP or AMWA MWC certification.
