Medical Writer II, Oncology

Johnson & Johnson Innovative Medicine; Leiden; Híbrido; EUR 54 000 - 85 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary

Annual bonus

Disability accommodations

Resumo da oferta

Johnson & Johnson Innovative Medicine is seeking a Medical Writer II, Regulatory Medical Writing to support Oncology within the IDAR group. The role is hybrid (3 onsite days) and may be located across Beerse, Leiden, High Wycombe/Maidenhead, Toronto or Spring House/Titusville.

Collaboration across global teams and adherence to regulatory standards are essential. Ideal candidates have 2+ years in regulatory medical writing, a scientific degree, and strong English communication.

Qualificações

• A university/college degree in a scientific discipline.
• Advanced degree preferred.
• At least 2 years of pharma/regulatory medical writing experience.
• Strong oral and written English communication skills.

Responsabilidades

• Write and coordinate basic clinical documents (Phase 1 protocols, 1st-in-class CSRs, IBs).
• Contribute to/coordinate low to medium complexity regulatory documents (Phase 2/3 CSRs, protocols, summaries).
• Perform document QC, literature searches, and reference listing with supervision.

Conhecimentos

Regulatory writing

English fluency

Data summarization

Team collaboration

Formação académica

Science degree

Advanced degree preferred

Ferramentas

Word

Excel

PowerPoint

Outlook

Descrição da oferta de emprego

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 II, 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- Requisition Number: R-096079
• Belgium, Netherlands- Requisition Number: R-097258
• United States - Requisition Number: R-097262
• Canada - Requisition Number: R-097266

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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 (within the TA and across TAs) 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

• Writing and coordinating basic clinical documents such as, but not limited to, 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, but not limited to, Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses under supervision.
• Performing document QC, completes list of abbreviations or references, conducts literature searches, and performs other basic tasks with supervision as needed.
• Participating in and may be leading cross-functional document planning and review meetings. Working in a team environment with some guidance while increasing independence for longer-term activities.
• Taking an active role on assigned projects with respect to timing, scheduling, and tracking.
• 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.

In Accordance With Experience Level

• Guiding or training cross-functional team members on processes and best practices.
• Leading early- or late-stage compound writing teams with supervision, as required.
• Learning and adhering to SOPs, templates, best practices, policies, Medical Writing Style Guide.
• Regularly meeting with manager and mentors and attending departmental meetings.
• Attending cross-functional meetings as appropriate (eg, project kick-off and review meetings, study team meetings, Global Program Team meetings).
• 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 provide peer review.

Principal Relationships

• Internal manager, other writers, cross-functional contacts (eg, 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.

Are you ready to join our team? Then please read further!

Qualifications / Requirements

• A university/college degree in a scientific discipline is the minimum requirement, with an advanced degree (eg, 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 (eg, Microsoft Word, Excel, PowerPoint, Outlook).

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 Aff 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 60,000 to 96,255 euro.

Netherlands: The anticipated base pay range for this position is 53,500 to 85,445 euro.

In addition to base pay, we offer the following benefits*: 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. Moreover, we offer 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. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

Required Skills

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

The anticipated pay range for this position, in the primary posting location, is

The anticipated pay ranges for additional locations are

• Belgium: The anticipated base pay range for this position is 60,000 to 96,255 euro.
• Netherlands: The anticipated base pay range for this position is 53,500 – 85,445 euro.

Benefits

In addition to base pay, we offer the following benefits*: 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. Moreover, we offer 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. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

Additional Information

In addition to base pay, we offer the following benefits*: 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. Moreover, we offer 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. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.