2 дня назад
Medical Writer II, Oncology
60 000 - 96 255€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Medical Writer II, Oncology (Regulatory Medical Writing): Authoring and coordinating clinical and regulatory documents for oncology programs with an accent on clinical study reports, protocols, investigator brochures, regulatory responses, and document quality control. Focus on interpreting scientific and medical data, coordinating cross-functional reviews, establishing document timelines, and applying ICH and regulatory requirements.
Location: Hybrid, with 3 days onsite weekly in Beerse, Belgium; Leiden, the Netherlands; High Wycombe or Maidenhead, the UK; Toronto, Canada; or Spring House or Titusville, United States. Remote work may be considered case by case with company approval.
Salary: Belgium €60,000–€96,255 per year; Netherlands €53,500–€85,445 per year.
Company
Johnson & Johnson MedTech develops healthcare and medical solutions designed to prevent, treat, and cure complex diseases.
What you will do
- Write and coordinate clinical documents, including Phase 1 protocols, Phase 1/2 clinical study reports, study tables, narratives, and initial investigator brochures.
- Contribute to and coordinate Phase 2/3 clinical study reports and protocols, investigator brochure updates, summaries, and regulatory responses under supervision.
- Perform document quality control, literature searches, reference and abbreviation management, and related medical writing tasks.
- Plan and participate in cross-functional document reviews, project kick-offs, study team meetings, and global program team meetings.
- Establish document timelines and strategies, track assigned projects, and collaborate with clinical, regulatory, biostatistical, and external partner teams.
- Support process improvement and, as experience develops, guide team members, lead writing teams under supervision, and mentor junior staff.
Requirements
- University or college degree in a scientific discipline; a Master’s degree, PhD, or MD is preferred.
- At least 2 years of relevant pharmaceutical or scientific experience.
- 2–4+ years of regulatory medical writing experience.
- Strong written and oral English communication skills are required.
- Ability to interpret and summarize scientific, medical, and statistical data with strong attention to detail and problem-solving skills.
- Knowledge of regulatory guidance, including ICH requirements, plus proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
Culture & Benefits
- Collaborative, inclusive environment working across clinical, regulatory, biostatistical, and medical affairs functions.
- Annual bonus or sales commission opportunities depending on pay grade and location.
- Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
- Well-being reimbursement and programs supporting financial, physical, and mental health.
- Insurance plans, service anniversary awards, and recognition programs, subject to local plan terms.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
2 дня назад
Clinical Trials Medical Writer (Clinical Research)
77 000 - 92 000$
4 дня назад
Clinical Research Coordinator II (Oncology)
58 798 - 77 435$
4 дня назад
Principal Medical Writer (Medical Communications)
95 000 - 105 000$
6 дней назад
Principal Strategic Medical Writer
109 500 - 208 500$
4 дня назад
Senior Strategic Medical Writer
96 500 - 183 500$
3 дня назад
Medical Writer (Medical Communications)
80 000 - 110 000$