Darshana Pukale

Medical Writing : Narrative

· Serves as medical writing lead on complex clinical documents/or assigned therapeutic/product areas

· Written Safety narratives across therapeutic areas like Cardiology, Neurology, Diabetology etc.

· Conducting Quality checks of the documents

· Conducting literature search – Epidemiology of the indications specified in the protocols.

· Develops and manages timelines for document development

· Competence in completing good first draft technical reports or clinical reports within a reasonable timeframe with limited guidance

· Leading the activities for assigned project

· Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.

Regulatory affairs:

· Perform the quality checks (bookmarks & hyperlinks) activity on assigned CTR.

· Perform hypertext linking for the documents in the client application, also perform the quality checks on hypertext links and do the necessary modifications in the client application, when necessary.

· Creation of bookmarks & hyperlinks & perform the peer QC with validation checks on legacy documents.

· Processing of Safety reports like RMPs, PBRER, DSURs and Clinical reports like Clinical trial protocol, BA reports etc in the Insight Publisher tool.

Project Management:

• Mentored and guided employees to foster proper completion of assigned duties.
• Built strong relationships with customers through positive attitude and attentive response.
• Coached team members in customer service techniques, providing feedback and encouragement toward reaching sales goals.
• Conducted training and mentored team members to promote productivity and commitment to friendly service.
• Led team of 18 members while providing exceptional customer service.
• Assisted with new hire processing and existing training programs.
• Facilitated training for associates through daily coaching and regular performance appraisals.

Narrative writing :

· Experienced in writing over 300 narratives across specialties like Endocrinology, Internal medicine, Oncology, Cardiology.

· Performed timely submission of narratives and met client expectations.

· Development of monograph for over 50 different salts.

Safety Case Processing:

· Database entry of the safety cases received

· Case processing, CIOMS generation and submission to the Regulatory authorities.

· Writing brief narrative for the specified case as a past of CIOMS processing.

Site Identification :

· Conducted more than 500 global feasibilities across various therapeutic areas , discussing Protocols with the investigators

· Responsible for co ordination with the team in delivering quality data to the client.

· Responsible for planning and utilization of resources to maximum.

· Responsible for co-coordinating with the Business development team for the project status

. Performed on-site visit for site assessment

· Performing IPQC activities, giving line clearance

· Overall monitoring activities manufacturing department (compliance with GMP)

· Provided training on the different dosage forms to QC staff

· Reviewing of batch records and giving final release before dispatch

• Identified training needs and organized training interventions to meet quality standards.
• Reported production malfunctions to managers and production supervisors.
• Prepared and collection production reports.

· Monitoring Quality Assurance (QA) activities in various departments (liquids, semi-solids), and performing IPQC

· Monitor Good Manufacturing Practices (GMP) in raw materials department (RMD), stores departments in addition to the above departments

· Preparing monthly status reports of QA and GMP monitoring activities

· Involved in preparation of Annual Product Review (APR) for Zytee gel (a Raptakos product)

· Monthly quality inspection visit to tin manufacturing unit (primary packing material for food)

· Involved in internal audits with senior manager in liquid, injection, semi-solid, tablet, stores department