Analyst, Regulatory Medical Writing

Job title:

Analyst, Regulatory Medical Writing

Company

Johnson & Johnson

Job description

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 https://www.jnj.comJob Function: Medical Affairs GroupJob Sub Function: Medical WritingJob Category: ProfessionalAll Job Posting Locations: Espoo, Uusimaa, Finland, Leiden, South Holland, Netherlands, Lyon, Rhone, France, Neuss, North Rhine-Westphalia, Germany, Turnhout, Antwerp, BelgiumJob Description:Analyst, Regulatory Medical WritingAbout Innovative MedicineOur 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 atPlease 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-008756
• EU (e.g., Belgium, Finland, France, Germany, Netherlands) – Requisition Number: R-009077
• Switzerland – Requisition Number: R-009084
• United States – Requisition Number: R-009090
• Canada – Requisition Number: R-009088

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.This is a hybrid or remote role available in all locations within Europe and North America. While specific cities are listed in the locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. Remote work options may be considered on a case-by-case basis and if approved by the Company.We are searching for the best talent for Analyst, Regulatory Medical Writing.As Analyst, Regulatory Medical Writing, you will support one or more of our therapeutic areas (Oncology, Immunology, Neuroscience, Cardiopulmonary, and Specialty Ophthalmology). Within our Regulatory Medical Writing team, you will join a cohort of writers undergoing internal training to author diverse regulatory medical writing documents. The target start date is 1 September 2025.Purpose:

• Learn the regulatory medical writing role and pharmaceutical industry and business.
• Learn to work in a team environment and matrix.
• Learn internal standards, regulatory, and publishing guidelines.
• Learn internal systems, tools, and processes.
• Help to prepare sections of documents and prepare basic documents under supervision.
• Assist with routine tasks per established procedures.

You will be responsible for:

• Prepare components of clinical and regulatory documents and write basic documents such as tables of studies, narratives, protocol amendments, investigator’s brochure updates and addenda under supervision.
• May assist with document QC, abbreviations, references, literature searches, and other tasks.
• Learn how to interpret, summarize, and present statistical and medical information.
• Learn to work in a matrix environment and gain an understanding of the medical writing responsibilities on project teams.
• Attend cross-functional meetings with other writers as appropriate (eg, project kick-off and review meetings).
• Learn and adhere to SOPs, templates, best practices, policies, and Medical Writing Style Guide.
• Regularly meet with manager and mentors and attend departmental meetings.

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.
• Strong oral and written communication skills in English.
• Ability to understand and summarize scientific data.
• Ability to function in a team environment and to build solid and positive relationships with co-workers.
• Demonstrated problem-solving skills.
• Attention to detail.
• Organizational skills and time management skills.
• Demonstrated learning agility.
• Ability to learn and apply knowledge of regulatory guidance documents such as ICH requirements.
• Working knowledge of Microsoft Office programs (eg, Microsoft Word, Excel, PowerPoint, Outlook).

BenefitsWe 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-benefitsAll 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.#LI-Hybrid#LI-Remote

Expected salary

Location

Turnhout, Antwerpen

Job date

Sat, 12 Apr 2025 04:31:58 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (jobsnear.org) you saw this job posting.