Devaki G Email & Phone Number

Experienced Medical Writer with a demonstrated history of working in the Pharmaceutical industry. Skilled in Communication, Presentation Skills, Biotechnology, Management, and Report Writing. Strong media and communication professional with a Bachelor of Engineering (B.E.) focused in Biotechnology from New Horizon College of Engineering.

• 

  Medical Writer 1

  Parexel

  Jun 2017 - Present - Bengaluru, Karnataka, India

  • Gather, Review, Analyze, and Evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: model informed consents, interim and final clinical study reports, and safety aggregate reports.• Serve as the Medical Writing representative (Lead) on assigned project teams and demonstrate document leadership, with departmental supervision: communicate content requirements, coordinate and conduct… Show more • Gather, Review, Analyze, and Evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: model informed consents, interim and final clinical study reports, and safety aggregate reports.• Serve as the Medical Writing representative (Lead) on assigned project teams and demonstrate document leadership, with departmental supervision: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress ontasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs.• Distribute final documents to project team and client.• Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files andclient deliverables.• Project management activities such as contractual andfinancial aspects when needed.• Keep abreast of professional information and technologythrough workshops and conferences (when approved) and assure appropriate transfer of that information to the department.• Mentor new staff as well as less experienced departmental members.• Work on various tools used in project management such as VEEVA, SharePoint, PMED/ELVIS.• Estimate required resources and timely delivery of documents to client.• Experienced in early phase and late phase projects.• Coordinating production and distribution of draft and final documents to project team and client. Ensure that all work is complete and of high quality prior to team distribution orshipment to client. Show less

• 

  New Horizon College Of Engineering

  A