Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team are recruiting for an experienced regulatory medical writer to join our diverse team of medical writers for immunology indications.
Our team is in locations across the globe. The position may be located in the US, Canada, Europe, or India. 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!
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/.
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For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Principal Responsibilities:
- Writes or coordinates clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
- Leads cross-functional document planning and review meetings. Interacts with cross-functional colleagues on document content and champions medical writing 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.
- Actively participates in or leads process working groups.
- Coaches or mentors more junior staff on document planning, processes, and content. Provides peer review as needed.
Qualifications
Education and Experience Requirements:
- A university/college degree in a scientific field is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
- At least 6 years of relevant pharmaceutical/scientific experience including at least 4 years of regulatory medical writing experience is required.
Other:
- Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in all document types under general supervision.
- Proficiency in written and spoken English is essential, together with excellent oral and written communication skills.
- Strong attention to detail.
- Ability to collaborate with cross-functional global teams across time zones, requiring some flexibility in your daily routine.
- Builds productive relationships with cross-functional team members.
- Has strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves complex problems under supervision.
- Organizes time well and demonstrates learning agility.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
The anticipated base pay range for this position is 105000 to 169050.
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 of Work, Personal and Family Time - up to 40 hours per calendar year
- Additional information can be found through the link below. https://www.careers.jnj.com/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.