Senior Analyst, Immunology Regulatory Medical Writing

At Johnson & Johnson Innovative Medicine (IM), what matters most is helping people live full and healthy lives.

We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.

IM Research & Development discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension, and cardiovascular and metabolic diseases.

Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team are recruiting for a Senior Analyst, Immunology Regulatory Medical Writing to support our Immunology therapeutic area.

This position is open globally and may be located in North America (eg, Spring House, PA, Raritan, NJ, Titusville, NJ, or Canada), Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy, Poland, Bulgaria or Switzerland), or other countries.

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

Are you ready to join our team? Then please read further!
Key Responsibilities:


* Prepare and finalize clinical documents such as, but not limited to, clinical study reports, investigator's brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents.


* Lead cross-functional document planning and review meetings.

Interact with peer writers and colleagues from other departments.

Able to lead program-level or submission writing teams with supervision.

Able to lead process working groups.


* Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed.


* Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.


* If a lead writer for a program: Be the primary point of contact and champion for medical writing activities for the clinical team.

Responsible for planning, setting strategy, and leading writing group for assigned program.


* Maintain and apply knowledge of the industry, company, and regulatory guidelines.



* A minimum of a Bachelor's or equivalent University/College degree is required.

Advanced degree (Masters, PhD) preferred.


* A minimum of 6 years of relevant pharmaceutical/scientific experience is required.


* A minimum of 4 years of relevant medical writing experience is required.


* Authoring experience with investigator brochures, clinical study protocols, and clinical study reports.

Experience with common technical document summaries is preferred.


* Strong leadership skills, both in time management and in project/process management is required.


* Must have strong attention to detail.


* Must have strong oral and written communication skills.


* Must be able to resolve complex problems under supervision.
...