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**Job Function: **
Medical Affairs Group
**Job Sub Function: **
Medical Writing
Job Category:
Professional
All Job Posting Locations:
Horsham, Pennsylvania, United States of America
Job Description:
Johnson & Johnson US Medical Affairs is recruiting for a **Manager Medical Writer **located in our Horsham, Pennsylvania. This is a hybrid role that will require 3 days in the Horsham office.
We are looking for a Manager Medical Writer to join the Scientific Communications team, supporting our Immunology therapeutic area. The writer will support publications (e.g., manuscripts, abstracts, posters, presentations, and slide decks) as assigned, to develop peer-reviewed publications and congress submissions communicating data from our company-sponsored clinical and observational studies in addition to real-world evidence analyses.
Key Responsibilities:
- Collaborate with Johnson & Johnson US and global stakeholders, authors, and steering committee members throughout the publication development process. May collaborate with external vendors on projects. Manage correspondence with congress organizers and other personnel.
Medical writing will include but is not limited to:
- Lead writing, editing, and revising manuscripts, abstracts, posters, and/or presentations. As agreed upon by authors, develop all drafts and final submission copies. Additional pub extenders (Plain Language Summaries, graphical abstracts, etc.) also in scope.
- Provide editorial support for any vendor-assigned congress work or manuscripts to meet timeline expectations. Work closely with SCL and vendor account lead to ensure lead (vendor) writer is supported with data, Share Point access, and document review.
- Manage working group meetings and collaborate with authors to advance the development of manuscripts/abstracts/posters/presentations.
- Review and interpret data and source documents for information required for publication development. Lead mock-up development of data displays (e.g., tables and figures).
- 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 repositories.
- Demonstrate mastery of relevant publication 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, and other guidelines pertaining to study protocols and clinical study reports.
- May perform other duties as assigned.
Manage assigned writing projects:
Attend meetings and support assigned therapeutic area(s) publication team(s).
Manage 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 mandatory approvals.
Manage project review/approval in automated workflow system.
May perform other duties as assigned.
Education:
Required Minimum Education: Bachelor’s degree or equivalent. Masters, PhD, or PharmD desirable.
Experience and Skills:
Required Years of Related Experience: Minimum of 5 years of relevant publication writing experience in the pharmaceutical industry.
Required Knowledge, Skills, and Abilities:
We would value a colleague with these qualities:
- Ability to learn new concepts 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 attention to detail
- 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
- Familiarity with relevant publication, industry best practices and publication guidelines
- Learning agility and attention to detail
- Ability to build solid and positive relationships with cross-functional team members
Preferred:
- Microsoft Word, Excel, Power Point, Microsoft Teams, SharePoint
- Publications systems experience desired
- ISMPP CMPP or AMWA MWC certification
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via _https://www.jnj.com/contact-us/careers_ . Internal employees contact AskGS to be directed to your accommodation resource.
**Required Skills: **
Preferred Skills:
Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Copy Editing, Data Synthesis, Industry Analysis, Medical Affairs, Medical Communications, Process Improvements, Proofreading, Quality Validation, Standard Operating Procedure (SOP), Tactical Planning, Technical Credibility