Pallavi Kamath Email & Phone Number

Thane, MH, IN

Thane

Thane, Maharashtra, India

• Key Responsibilities
• Perform Medical Writing activities as specified by the SOP on the assigned project in a timely and efficient manner so as to ensure seamless delivery and high levels of customer satisfaction
• Perform robust quality check and/or review of all assigned clinical documents within established timelines
• Provide guidance to Senior Narrative Writers and Junior Narrative Writers on their narrative writing deliverables to achieve the defined quality within agreed timelines
• Perform ongoing assessment for the direct reports and recommend necessary training for the team in the identified gap areas
• Provide annual performance appraisals of direct reports

Thane, Maharashtra, India

• Key Responsibilities
• Draft patient narratives and other clinical documents in accordance with documented guidelines, SOPs and timelines. Ensure that the data is objectively and accurately represented. Responsible for the final deliverable.
• Perform quality check and/or review of patient narratives
• Work effectively with other writers, communicating project information in a timely manner I
• Disseminate the learnings at regular intervals across teams
• Be prepared for any audits and inspections

• Key Responsibilities
• Prepare and review patient narratives and other clinical documents within established timelines that are of high quality for scientific content, data accuracy, and in compliance with regulatory guidelines, standard.
• Provide regular status updates as required to the line manager/project manager
• Escalate issues promptly to the line manager/ project manager
• Be prepared for any audits and inspections

Mumbai, Maharashtra, India

• Key Responsibilities
• Primarily responsible for the authoring and co-ordination of IND/NDA Annual Reports
• Perform initial literature search using standard medical databases like Pubmed and Embase for NDA Annual Report bibliography and prepare the bibliography
• Co-ordinate the review, revision and approval of documents
• Ensure that the documents are available to the Regulatory Affairs department in a timely manner for submission to the Regulatory Authorities
• Train newly joined associates with respect to the process specific activities and making them competent to go for live production activities

Master Of Pharmaceutical Marketing

Bachelor Of Pharmacy (Bpharm)