Principal Medical Writer: Drive Global Regulatory Submissions

Overview As a Principal Medical Writer, you will lead high-quality scientific documents to support regulatory submissions and publications. You collaborate with clinical, regulatory, and medical affairs teams to translate data into clear narratives. The role is on-site in a collaborative environment that values expertise and innovation. You will shape...

As a Principal Medical Writer, you will lead high-quality scientific documents to support regulatory submissions and publications. You collaborate with clinical, regulatory, and medical affairs teams to translate data into clear narratives. The role is on-site in a collaborative environment that values expertise and innovation. You will shape scientific...

Single sponsor Principal I/II Medical Writer (Clinical / Submissions exp) fully remote in Italy, UK, Spain, Poland or Ireland.Potrebbe essere proprio lei il candidato/la candidata ideale per questo lavoro. Legga tutte le informazioni associate e invii la sua candidatura.Updated: TodayLocation: Remote, MI, ItalyJob ID:25112590-OTHLOC-3531-2DRDescriptionSingle...

Experteer Italy is seeking a Principal Medical Writer to lead high-quality regulatory and publications documents. You will collaborate across clinical, regulatory and medical affairs teams to translate data into clear narratives that support submissions and global communication. The role is on-site in a collaborative environment that values expertise,...

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the...

RA Principal Associate (M/F/X) Tasks: Lead and execute regulatory strategies for assigned products and projects. Prepare, compile, and submit high-quality regulatory applications, including variations, renewals, and responses to health authority questions. Ensure regulatory dossiers remain compliant and up to date for EU, UK, and Switzerland markets. Provide...

Conduct medical review of clinical trial and post-marketing safety data, including adverse events (AEs), adverse drug reactions (ADRs), coding, causality, expectedness, seriousness assessments, and benefit-risk evaluations.Provide medical oversight and review of safety documentation, including narratives, aggregate reports, annual and periodic safety...

Select how often (in days) to receive an alert:Non aspetti a candidarsi dopo aver letto questa descrizione: per questa opportunità è previsto un elevato volume di candidature.The Medical Director has a direct reporting line to the Country Manager.Its main function is to ensure that all scientific and clinical activities comply with current regulations and...

Overview As Senior Global Patient Safety Physician at Chiesi, you lead safety science for assigned products, shaping proactive risk management and safety surveillance. You collaborate across Clinical Development, Medical Affairs, Regulatory, Quality and external partners to integrate safety data into development plans and submissions. You drive science-led...