Senior Clinical Writer - Remote

Senior Clinical Safety Writer

My client is a mid-sized global healthcare provider, looking for a Clinical Safety Writer to join their diverse, collaborative and inclusive Medical Writing team.

The Clinical Safety Writer will carry out the creation of documents in accordance with client specifications, whilst maintaining written, Scientific and Ethical standards. If you are an experienced Medical Writer with extensive experience within a Clinical Safety Environment, please read below…

Responsibilities;

• Preparation of study documents such as protocols, informed consent documents, CSRs, patient narratives investigator drug brochures, summary documents, and other documents in accordance with regulatory requirements Including QC/review of documentation as required
• Coordination of internal and client document review cycles
• Attend project-related meetings, as needed.
• Serve as publishing point-of-contact in conjunction with the document coordinator to publish CSRs or other documents, as required
• Create and manage project-specific timelines, adaptation of timing and milestones based on client requirements
• Identify and communicate risks associated with document delivery and propose mitigation plan

Requirements;

• Life science or related degree, Graduate degree preferred
• Minimum of 3 years of clinical pharmaceutical industry
• Excellent written and spoken English, able to accurately interpret data and express findings in a clear and concise written manner
• Excellent project/time management and organisational skills
• Comprehensive Microsoft Office specifically Word, PowerPoint and Excel 
• Attention to detail—style, consistency, grammar, syntax, scientific accuracy
• Thorough knowledge of applicable regulatory requirements and guidelines in particular ICH E3, E6, and E9

If you are interested, get in touch with me ASAP…

Vincenzo B. Dessena BSc. MSc.

Email: vdessena (at) barringtonjames.com