Medical Writer III, Oncology

7555-Janssen Pharmaceutica NV Legal Entity

Geel

Hybrid

EUR 73,000 - 115,000

Full time

8 days ago

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Benefits offered by this job

Hybrid work model

Remote work options (case-by-case)

Job summary

Johnson & Johnson is seeking a Medical Writer III, Regulatory Medical Writing to support Oncology within the Integrated Data Analytics & Reporting (IDAR) organization. The role may be located Beerse, Belgium; Leiden, Netherlands; High Wycombe/Maidenhead, UK; Toronto, Canada or Spring House / Titusville, United States.

It is Hybrid (3 days onsite weekly) with remote work options considered case-by-case. You will lead document planning, coordinate cross-functional reviews, and mentor junior

Qualifications

University/college degree in a scientific discipline required.
Advanced degree (Masters/PhD/MD) preferred.
6+ years in pharmaceutical/scientific industry with 4+ years regulatory medical writing.
English writing and speaking essential; ability to collaborate across time zones.

Responsibilities

Write or coordinate regulatory documents (CSRs, IBs, protocols, RMPs, regulatory responses).
Lead cross-functional document planning and review meetings.
Interact with cross-functional colleagues on document content and processes.
Establish document timelines and strategies with supervision.
Lead writer for most compounds or submissions under supervision.
Mentor junior staff and provide peer reviews.

Skills

Business Writing

Clinical Research and Regulations

Clinical Trials Operations

Coaching

Collaboration

Communication

Copy Editing

Data Synthesis

Industry Analysis

Medical Affairs

Medical Communications

Problem Solving

Process Oriented

Proofreading

Quality Standards

Research Ethics

Standard Operating Procedure (SOP)

Education

Bachelor's degree in a scientific discipline

Advanced degree (Masters/PhD/MD)

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com. 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 as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Medical Affairs Group

Job Sub Function

Medical Writing

Job Category

Professional

All Job Posting Locations

Beerse, Antwerp, Belgium, Leiden, South Holland, Netherlands

Job Description

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. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Medical Writer III, Regulatory Medical Writing to support Oncology within our Integrated Data Analytics & Reporting (IDAR) business. The position may be located 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. 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): United Kingdom: R-105516 Belgium/Netherlands: R-105590 United States: R-105615 Canada: R-105619 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Are you ready to join our team? Then please read further!

Purpose

Able to write and coordinate basic and complex documents, independently when working within own therapeutic area (TA), and under supervision when working across TAs. Leads in a team environment and matrix. Able to function as a lead MW on most compounds, under supervision. Actively participates in or leads process working groups. Provides input into functional tactics/strategy (eg, writing teams, process working groups). Highly proficient in the use of internal systems, tools, and processes.

Responsibilities

Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
Leading cross-functional (eg, with clinical team) document planning and review meetings.
Interacting 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.
Completing all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.
Able to function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision.
Is primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
Coaching or mentoring more junior staff on document planning, processes, and content.
Provides peer review as needed.
Actively participating in or leads process working groups.

Principal Relationships

Internal: manager, other writers cross-functional contacts (eg, clinical, regulatory, or biostatistical functions) involved in the preparation and planning of clinical documents. External: May interact with or oversee day-to-day work by contractors or external service providers as needed under supervision. May collaborate with external partner company staff on codeveloped compounds.

Education and Experience Requirements

A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. At least 6 years of relevant pharmaceutical/scientific industry experience including at least 4 years of regulatory medical writing experience! Oncology therapeutic area experience is preferred. Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision. Compound lead and/or submission lead experience is preferred. Proficiency in written and spoken English is essential, along with the ability to collaborate with global teams and stakeholders across time zones, requiring some flexibility in your daily routine. Able to build solid and positive relationships with cross‑functional team members. 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. Able to resolve complex problems under supervision. Demonstrate learning agility (self‑development) and mentoring competency (development of others). Strong attention to detail. Builds solid and productive relationships with cross‑functional team members.

Benefits

We offer a competitive salary and extensive benefits package. 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, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Belgium: The anticipated base pay range for this position is 72,500 to 115,230 euro. Netherlands: The anticipated base pay range for this position is 64,000 - 103,040 euro.

* an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
* vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, and programs for financial, physical and mental health.
* we also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.

Required Skills