Medical Writer II, Oncology in High Wycombe

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.

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.

We are searching for the best talent for Medical Writer II, Oncology. This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. Remote work options may be considered on a case-by-case basis and if approved by the Company.

Purpose

Develops within the medical writing role within the pharmaceutical industry. Works in a team environment and matrix. Performs routine tasks per established procedures. Gains knowledge and applies internal standards, regulatory, and publishing guidelines. With increasing skill, uses internal systems, tools, and processes. Writes and coordinates basic documents, preparing more complex documents in accordance with experience level. Functions as a lead writer on a project, indication, or a compound either early- or late-stage in life cycle under close supervision. Participates in process working groups.

You Will Be Responsible For

• Writes and coordinates basic clinical documents such as Phase 1 protocols, Phase 1/2 CSRs, table of studies, narratives, and initial IBs.
• Writes, contributes to, and/or coordinates 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.
• Performs document QC, completes list of abbreviations or references, conducts literature searches, and performs other basic tasks with supervision as needed.
• Participates in and may lead cross-functional document planning and review meetings.
• Works in a team environment with some guidance while increasing independence for longer-term activities.
• Takes an active role on assigned projects with respect to timing, scheduling, and tracking.
• Interacts with cross-functional colleagues on document content and champions MW 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.
• Guides or trains cross-functional team members on processes and best practices.
• Leads early- or late-stage compound writing teams with supervision, as required.
• Regularly meets with manager and mentors and attends departmental meetings.
• Completes all time reporting, training, and metrics database, and project tracking updates as required in relevant company systems.
• Maintains and applies knowledge of industry, company, and regulatory guidelines.
• Mentors more junior staff on document planning, processes, content, or provide 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.
• Resolves basic problems independently and more complex problems with supervision.
• 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

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.

Time off benefits include: Vacation 120 hours/year; Sick time 40 hours/year; Holiday pay 13 days/year; Work, Personal and Family Time up to 40 hours/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.