Manager, Oncology Regulatory Medical Writing

Company: Disability Solutions
Location: Raritan
Posted on: March 23, 2025

Job Description:

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.comJob Function: Medical Affairs GroupJob Sub Function: Medical WritingJob Category:ProfessionalAll Job Posting Locations:US063 NJ Raritan - 920 US Hwy 202Job Description:Manager, Oncology Regulatory Medical WritingAt Johnson & Johnson Innovative Medicine, 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.Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiopulmonary, and retina.Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team are recruiting for a Manager to support our Oncology therapeutic area. The position is located in the United States. 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 all types of clinical documents.
• Lead in a team environment. Work with a high level of independence and take a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking.
• Lead or set objectives for others on team projects and tasks, eg, lead process working groups.
• Guide or train cross-functional team members on processes and best practices.
• May lead project-level/submission/indication writing teams.
• Proactively provide recommendations for departmental process improvements.
• If a lead writer for a program: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
• Actively participate in medical writing and cross-functional meetings.
• Maintain knowledge of industry, company, and regulatory guidelines.
• Coach or mentor more junior staff on document planning, processes, content, and provide peer review as needed; may oversee the work of other medical writers, external contractors, and document specialists supporting a project.
• May interact with senior cross-functional colleagues to strengthen coordination between departments.
• May represent Medical Writing department in industry standards working groups.
• If a people manager:
• Manage direct reports in Medical Writing. Set objectives for individual team members. Regularly meet with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
• Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal-setting, and performance discussions.Education:University/college degree required. Masters or PhD preferred.Experience and Skills:We would value a colleague with these qualities:
  • At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required!
  • If a people manager, preferably up to 2 years of people management experience.
  • Oncology therapeutic area experience preferred.
  • Attention to detail.
  • Excellent oral and written communication skills are pivotal to engage in cross-functional discussions.
  • Expert project/time management skills.
  • Strong project/process leadership skills.
  • Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
  • Able to resolve complex problems independently.
  • Demonstrate learning agility.
  • Able to build and maintain solid and positive relationships with cross-functional team members.
  • Solid knowledge and application of regulatory guidance documents such as ICH requirements.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.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.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):UK & Europe 1] R-000337US 2] this posting: R-001016Canada 3] Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.For United States Applicants only:The anticipated base pay range for this position is $115,000 to $197,800.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 yearFor additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefitsThe 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.The anticipated base pay range for this position is :Additional Description for Pay Transparency:

Keywords: Disability Solutions, New Brunswick , Manager, Oncology Regulatory Medical Writing, Executive , Raritan, New Jersey