Planet Pharma · 3 hours ago
Sr. Clinical Evaluation Med Writer (Remote)
United States
Full-time
Remote
Mid, Senior Level
4+ years expPlanet Pharma is a company focused on clinical evaluation and regulatory affairs, and they are seeking a Senior Clinical Evaluation Med Writer. The role involves writing clinical evaluation reports, managing cross-functional teams, and conducting comprehensive literature searches to appraise clinical evidence.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Review and summarize scientific literature
Reports instances of complaints/adverse events from literature
Create responses for audit/submission queries
Maintains database of peer-reviewed literature
Appraise, analyze, summarize, and discuss clinical evidence from all the available sources
Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence
Develop state of the art on product family for its intended purpose
Create & maintain plans and reports for regulatory authorities
Review/approve other documentation for device development
Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements
Qualification
Required
Clinical Evaluation Report (CER) Writing Experience
Strong Project Management skills
Ability to work with and manage cross-functional teams
Bachelors with minimum 4 years of experience OR advanced degree with minimum 2 years of experience
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase