Medical Writer Ii, Oncology

Johnson And Johnson

High Wycombe

Híbrido

GBP 40.000 - 60.000

Jornada completa

Hace 13 días

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Descripción de la vacante

Johnson & Johnson seeks a Medical Writer II, Regulatory Medical Writing to support Oncology within the Integrated Data Analytics & Reporting team. The role is hybrid (3 days onsite weekly) and located in the UK, with collaboration across global postings.

You will author diverse regulatory documents, lead projects with supervision, and mentor junior staff while adhering to SOPs and industry guidelines.

Formación

Bachelor's degree in a scientific field; advanced degree preferred.
At least 2 years of pharmaceutical/scientific experience.
2 to 4+ years of regulatory medical writing experience.
Strong oral and written English communication.
Ability to interpret, summarize scientific or medical data.
Ability to function in a team and build cross-functional relationships.
Emerging leadership and project management skills.

Responsabilidades

Write and coordinate basic clinical documents such as Phase 1 protocols, Phase 1/2 CSRs, tables of studies, narratives, and initial IBs.
Contribute to and coordinate low to medium complexity clinical and regulatory documents under supervision.
Perform document QC, create abbreviations/references lists, conduct literature searches.
Participate in cross-functional document planning and review meetings.

Conocimientos

Strong English communication

Scientific data interpretation

Time management

Project management

Emerging leadership

Problem-solving

Educación

Bachelor's degree in science

Advanced degree preferred

Herramientas

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Descripción del empleo

Company Overview

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. 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: High Wycombe, Buckinghamshire, United Kingdom

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. 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. 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

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.

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).

Additional Responsibilities

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. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organisation. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

All qualified applicants will be considered for employment without regard to any other characteristic protected by law.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodations.

Required and Preferred Skills