Senior Medical Writer – Safety Lead (Remote)

Synchrogenix Philippines, Inc.; Manila; Remoto; PHP 1.200.000 - 2.400.000; Tempo integral

Resumo da vaga

Veristat is seeking a Senior Medical Writer - Safety Focus to lead the creation of aggregate safety reports and to act as project lead on smaller engagements, collaborating closely with clients and internal teams. The role supports larger programs as part of a larger delivery team, ensuring quality and regulatory compliance.

Candidates should have 5+ years of regulatory writing experience in safety reports, with DSURs, PSURs, PBRERs, and related documents, and strong Word processing and

Qualificações

• Bachelor’s degree or higher in a scientific discipline strongly preferred.
• 5+ years of regulatory writing experience with aggregate safety report writing including DSURs, PSURs, PBRERs, RMPs, PADERs, ACOs and safety topic reviews.
• Understand regulatory authority guidelines to lead internal project teams and anticipate effects on final products for health authority approval/acceptance.
• Experience in development of aggregate safety reports.

Responsabilidades

• Lead on smaller projects interfacing directly with clients and support larger engagements as a delivery team member.
• Contribute to document authorship for safety reports and ensure quality and regulatory compliance.

Conhecimentos

MS Word

Document editing

Team collaboration

Time management

Attention to detail

Formação

Bachelor’s degree in a scientific discipline

Descrição da vaga

Veristat is seeking a Senior Medical Writer - Safety Focus to lead the creation of aggregate safety reports and to act as project lead on smaller engagements, collaborating closely with clients and internal teams. The role supports larger programs as part of a larger delivery team, ensuring quality and regulatory compliance.

Candidates should have 5+ years of regulatory writing experience in safety reports, with DSURs, PSURs, PBRERs, and related documents, and strong Word processing and