Medical Writer Specialist

il y a 10 heures


Nanterre, Île-de-France ProductLife Group Temps plein
Job Title: Medical Writer Specialist

We are seeking a highly skilled Medical Writer Specialist to join our dynamic team at ProductLife Group. As a Medical Writer Specialist, you will be responsible for creating high-quality medical documents, including clinical trial reports, regulatory submissions, and safety reports.

Key Responsibilities:
  • Develop and maintain a deep understanding of regulatory requirements and guidelines, including GCP, ICH, and GVP.
  • Write and edit medical documents, including clinical trial reports, regulatory submissions, and safety reports, to ensure accuracy, clarity, and compliance with regulatory requirements.
  • Collaborate with cross-functional teams, including marketing, clinical, and regulatory, to ensure that medical documents meet business needs and regulatory requirements.
  • Conduct literature searches and analyze clinical evidence to support research, clinical evidence, product development, risk analysis, and regulatory submissions.
  • Prepare and review aggregate reports, including DSURs, PSURs, RMPs, and ACOs.
  • Identify and report suspected spontaneous adverse drug reaction reports to the appropriate Pharmacovigilance LOB in line with legal and company requirements.
Requirements:
  • Pharmacist or medical degree.
  • Minimum 4 years experience in PV operational activities.
  • Experience in preparation of signal and aggregate reports (PSUR, DSUR etc.).
  • BPPV France/GVP knowledge.
  • Database experience preferred.
  • Knowledge of current regulations.
  • Process oriented.
  • Rigorous and ability to work in a team.
  • Use of Microsoft Office tools.
  • Ability to multitask.
  • Flexibility.
  • Excellent communication skills in French and in English for business continuity.

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