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.
Qualifications 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.
The ability to build solid and positive relationships with cross‐functional team members.
The ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision is required.
This position will require up to 10% travel.
The anticipated base pay range for this position in the San Francisco Bay Area, CA is $ to $.
The anticipated base pay range for this position in all other U.
.
locations is $ to $.
The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year.
Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs.
medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits.
Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on company benefits, please go to.
https://www.
areers.
nj.
om/employee-benefits * The compensation and benefits information set forth in this posting applies to candidates hired in the United States.
Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.