Pharma jobs

R-OPENING AS MEDICAL WRITER

Regulatory Medical Writer
Neptune Consultants - Navi Mumbai, Maharashtra

Experience : 3 to 6 yrs

 Location : Mumbai 

Major Activities Write/edit regulatory documents (e.g. CSRs, DSURs, RMPs, contribute to CTD summaries). Participate in planning of analysis and data presentation to be used in study reports or summary documents. Act as a member of clinical trial teams following protocol finalization Act as documentation consultant in clinical trial teams to ensure compliance of documentation to internal company standards and external regulatory guidelines.

Act as project medical writer for various programs in clinical development and ensure medical writing resource allocation to studies within these programs. Contribute to process improvement initiatives Supervise outsourcing to external medical writers. Follow and track clinical trial milestones and resource requirements for assigned projects Training and mentoring of associates as required. Key Performance Indicators Preparation of clinical study reports and summary documents in accordance with standard processes with respect to timelines, and compliance to internal and external standards.

Completion of an adequate number of clinical documents (taking into account complexity) per year. Adequate representation on the clinical team or submission team, and effectiveness of communication and guidance. Appropriate communication of project resource needs and status Demonstration of appropriate leadership and influencing behaviour within RMW