Analyst II, Medical Writing, Immunology

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. Learn more at https://www.jnj.com

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

Professional

All Job Posting Locations:

Allschwil, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Spring House, Pennsylvania, United States of America, Toronto, Ontario, Canada

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Analyst II, Medical Writing, Immunology.

This role is available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States- Requisition Number: R-02370

Belgium & Netherlands - Requisition Number: R-026119

United Kingdom- Requisition Number: R-026119

Switzerland- Requisition Number: R-026110

Canada- Requisition Number: R-042336

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Purpose:

• Develops within the medical writing role within the pharmaceutical industry.
• Works in a team environment and matrix.
• Performs routine tasks per established procedures.
• Gains knowledge and applies internal standards, regulatory, and publishing guidelines.
• With increasing skill, uses internal systems, tools, and processes.
• Writes and coordinates basic documents, preparing more complex documents (within the TA and across TAs) in accordance with experience level
• Functions as a lead writer on a project, indication, or a compound either early- or late-stage in life cycle under close supervision.
• Participates in process working groups.

You will be responsible for:

• Writes and coordinates basic clinical documents such as, but not limited to, Phase 1 protocols, Phase1/2 CSRs, table of studies, narratives, and initial IBs.
• Writes, contributes to, and/or coordinates low to medium complexity clinical and regulatory documents such as, but not limited to, Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses under supervision.
• Performs document QC, completes list of abbreviations or references, conducts literature searches, and performs other basic tasks with supervision as needed.
• Participates in and may lead cross-functional document planning and review meetings. Works in a team environment with some guidance while increasing independence for longer-term activities.
• Takes an active role on assigned projects with respect to timing, scheduling, and tracking.
• Interacts with cross-functional colleagues on document content and champions MW processes and best practices. Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
• In accordance with experience level:
  • guides or trains cross-functional team members on processes and best practic