Medical Writer II, Oncology

About the role

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.

As Medical Writer II, Regulatory Medical Writing, you will support our Oncology therapeutic area within our Regulatory Medical Writing team, to author diverse regulatory medical writing documents. The position may be located in Beerse, Belgium; Leiden, The Netherlands; High Wycombe/Maidenhead, UK; Toronto, Canada; or Spring House / Titusville, United States. The position is hybrid (3 days onsite weekly). Remote work options may be considered on a case-by-case basis and if approved by the company.

Responsibilities

• Write and coordinate basic clinical documents such as Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, and initial IBs.
• Write, contribute to, and/or coordinate low to medium complexity clinical and regulatory documents such as Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses under supervision.
• Perform document QC, complete list of abbreviations or references, conduct literature searches, and perform other basic tasks with supervision as needed.
• Participate in and may lead cross-functional document planning and review meetings.
• Work in a team environment with some guidance while increasing independence for longer-term activities.
• Take an active role on assigned projects with respect to timing, scheduling, and tracking.
• Interact with cross-functional colleagues on document content and champion medical writing processes and best practices.
• Establish 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

• Guide or train cross-functional team members on processes and best practices.
• Lead early- or late-stage compound writing teams with supervision as required.
• Learn and adhere to SOPs, templates, best practices, policies, and the Medical Writing Style Guide.
• Meet regularly with manager and mentors and attend departmental meetings.
• Attend cross-functional meetings as appropriate (e.g., project kick-off and review meetings, study team meetings, Global Program Team meetings).
• Complete all time reporting, training, and metrics database, and project tracking updates as required in relevant company systems.
• Maintain and apply knowledge of industry, company, and regulatory guidelines.
• Mentor more junior staff on document planning, processes, content, or provide peer review.

Principal Relationships

Internal: manager, other writers, cross-functional contacts (e.g., clinical, regulatory, or biostatistical functions) involved in the planning and preparation of clinical documents.

External: May interact with or oversee the day-to-day work of contractors or external service providers as needed under close supervision. May collaborate with external partner company staff on codeveloped compounds.

Qualifications / Requirements

• A university/college degree in a scientific discipline is the minimum requirement, with an advanced degree (e.g., Master’s degree, PhD, MD) preferred.
• At least 2 years of relevant pharmaceutical/scientific experience is required.
• A range of 2 to 4+ years of regulatory medical writing experience is required.
• Strong oral and written communication skills in English.
• Ability to understand, interpret, and summarize scientific or medical data.
• Ability to function in a team environment and to build solid and positive relationships with cross-functional team members.
• Demonstrated problem-solving skills.
• Strong attention to detail.
• Strong time management and project/process management skills.
• Demonstrated learning agility; gains experience in interpreting, summarizing, and presenting statistical and medical information to ensure quality and accuracy of content with supervision.
• Emerging leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative). Resolves basic problems independently and more complex problems with supervision.
• Develops and applies knowledge of regulatory guidance documents such as ICH requirements.
• Sound knowledge of Microsoft Office programs (e.g., Microsoft Word, Excel, PowerPoint, Outlook).

Preferred Skills

• Business Behavior
• Business Writing
• Clinical Research and Regulations
• Clinical Trials Operations
• Coaching
• Collaboration
• Copy Editing
• Data Gathering and Analysis
• Data Savvy
• Document Management
• Industry Analysis
• Medical Affairs
• Medical Communications
• Problem Solving
• Process Oriented
• Proofreading
• Quality Standards
• Research Ethics

Pay

The expected pay range for this position is $92,000 – $148,350 USD. 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.

Benefits

• Subject to the terms of their respective plans, employees and/or eligible dependents are 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.
• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
  • Vacation – 120 hours per calendar year
  • Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
  • Holiday pay, including Floating Holidays – 13 days per calendar year
  • Work, Personal and Family Time – up to 40 hours per calendar year
  • Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
  • Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year