Medical Writer II, Oncology

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 positioned to innovate across the full spectrum of healthcare solutions today to deliver breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered an individual. We respect the diversity and dignity of our employees and recognize their merit.

About Innovative Medicine: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.

You will be responsible for:

• Writing and coordinating basic clinical documents such as Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, and initial IBs.
• Writing, contributing to, and/or coordinating 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.
• Performing document QC, completing list of abbreviations or references, conducting literature searches, and performing other basic tasks with supervision as needed.
• Participating in and may lead cross-functional document planning and review meetings.
• Interacting with cross-functional colleagues on document content and championing MW processes and best practices.
• Establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
• Guiding or training cross-functional team members on processes and best practices.
• Learning and adhering to SOPs, templates, best practices, policies, Medical Writing Style Guide.
• Completing all time reporting, training, and metrics database, and project tracking updates as required in relevant company systems.
• Maintaining and applying knowledge of industry, company, and regulatory guidelines.
• Mentoring more junior staff on document planning, processes, content, or providing peer review.

Qualifications / Requirements:

• A university/college degree in a scientific discipline is required. An advanced degree (e.g., Masters, PhD, MD) is preferred.
• A minimum of 2 years of relevant pharmaceutical/scientific experience is required.
• A minimum of 2 to 4+ years of regulatory medical writing experience is required, depending on tasks performed and level of supervision needed.
• Strong oral and written communication skills.
• Attention to detail.
• Ability to function in a team environment.
• Organises time well.
• Demonstrates learning agility.
• Builds solid and productive relationships with cross-functional team members.
• Gains experience in interpreting, summarising, 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.
• Develops and applies knowledge of regulatory guidance documents such as ICH requirements.

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

Benefits and Additional Information:

• 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.
• 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.
• Time off benefits include: Vacation 120 hours/year; Sick time 40 hours/year; Holiday pay 13 days/year; Parental Leave 480 hours; Bereavement Leave 240 hours; Caregiver Leave 80 hours; Volunteer Leave 32 hours; Military Spouse Time-Off 80 hours.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.