Haritha Gattu

• Authored/Co-authored/Reviewed (Clinical Study Reports, Clinical Study Protocols, Clinical Evaluation Reports, 2.4 Nonclinical Overview, 2.6 Nonclinical Summary, Investigative Brochers, IND, NDA, 2.5 Clinical Overview, 2.7 Summary Documents, ADR FJD, PMS, ICF, Abstracts, Publications, PBRERs, PSURs, BLA) documents whilst adhering to ICH guidelines and FDA and EMA guidance. • Prepared and reviewed regulatory submissions related to CMC, including INDs, NDAs, slide decks, manuscripts, posters, abstracts and variations. • Organized and facilitated kickoff and adjudication meetings to align the team on document strategy and content. Ensured timely internal and external reviews of draft and final documents. Facilitated meetings related to documentation from planning to approval of the documents. • Responsible to coordinate with the stake holders and vendors for development of documents involving submission deadlines, contributions, review cycles, QC, approval of the document, preparation of strategy, authoring, reviewing, etc. Provided input to project teams to support completion of accurate, quality regulatory documents. • Supported/Worked/Lead with other medical writers within the teams, for many of the tight timeline’s projects and ensured the timely and accurate deliverables, negotiating timelines as necessary. • Reviewed scientific documents to identify relevant source information and evaluated references to ensure accurate and well-supported report statements. • Worked on ordering the literature documents from the elibrary, Veeva vault, and many other sites internal/external organizations • Mentored junior writers on projects, development of documents, organization cycles, guidelines to follow, etc., • Provided the contributions on preparation of SOP templates for training juniors, QC structure within the organization etc.,

• Authored/Co-authored/Reviewed clinical documents CTD modules (2.5 Clinical Overview, 2.6 Nonclinical Summary, 2.7 Summary Documents, 2.4 Nonclinical Overview, Module 3), Clinical Study Reports, Protocols, DSURs, IND/NDA, PBRER, PSUR, HA Queries, PBRER, PSUR, DSUR. Provided clinical contributions for DSUR, PBRER, PSURs, 2.5 Clinical Overview on few therapeutics’ areas as a clinical lead. • Represented as a clinical lead to few therapeutic areas for providing clinical contributions/reviewing the documents (PBRER, PSUR, DSUR, 2.5 Clinical Overview, HA Response Documents etc.,) and providing input to the comments raised during the various review stages of the drafts while preparing to finalize the documents ensuring alignment with ICH, FDA, and EMA regulatory requirements. • Developed content with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. • Scheduled/conducted document-related meetings with pre-meeting agenda include discussion on the content, strategy, responsibilities, and provided the post-meeting minutes explaining the responsibilities of the stakeholders, contributions, timelines, and submission deadline of the document. • Worked/collaborated with various medical writers in vendor companies made them understand the need of the project. Reviewed the documents in various stages of the review cycles with stakeholders involved in finalizing the document. Also, managed the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed within the document review cycle or scheduled the meetings with the stakeholders/vendor medical writers to address the issue and resolve the comment. • Supported/Worked/Lead with other medical writers within the teams, for many of the tight timeline’s projects and ensured the timely and accurate deliverables, negotiating timelines as necessary.

• Authored/Reviewed the complex documents 2.5 Clinical Overview (updates to CDS, USPI, and SmPC labels), 2.4 Non-Clinical Overview, 2.6 Nonclinical Summary, 2.7 Summary Documents, Module 3, ADR FJD, HA Queries, PMS, Clinical Evaluation Report, BLA, IND, NDA, Investigative Brochure, Protocols, Clinical Study Reports, PBRER, and DSUR. • Authored/reviewed regulatory submissions related to CMC, including INDs, NDAs, slide decks, publications, posters, abstracts and variations. • Scheduled the document related meetings including the preparation of pre-meeting agenda (involving submission deadlines, estimated timelines, and points for discussion), and post-meeting minutes (with respective responsibilities of stakeholders such as clinical, statistician, toxicologist, pharmacologist, regulatory, medical, sponsors, research coordinators etc., involved in the development of the documents). • Conducted the literature search from various databases internal and external sources and segregated the articles primarily based on the document needs. Coordinated with various stakeholders to gather the respective contributions within the specified timelines. • Managed the various review cycles through the organization SharePoint, GDMS, Veeva vault etc., for version control of the drafts. Collaborated with stakeholders, vendors, for document review process, addressing/resolving the comments within the email communications or through scheduling the meetings. • Performed QC and Editorial reviews when necessary to supplement our QC Team's resourcing and Editing, proofreading, and formatting document text prior to final QC. • Mentored junior writers on document planning, processes, content, provide peer review as needed, organization structure, workflow, tools etc., • Managed deadlines and documents inventories while upholding strict accuracy and completeness standards.

• Evaluated various drugs which are in market in various aspects with various instruments as UV, HPLC, Mass Spectrometer. • Prepared various methods on evaluating the quality check of the drug by coordinating all analytical testing results. • Processed various methods to develop a particular method to evaluate the drug. • Worked with the Analytical research associate, as needed, to perform basic characterization. • Specialized and determined analytical methodologies for evaluating impurities, including cell based assays, protein, DNA.

Interprofessional field that studies and pursues the effective uses of biomedical data, information, and knowledge for scientific inquiry, problem-solving, decision making, motivated by efforts to improve human health.

• Research and method development on Fenoverine Product through RP-HPLC. • Published an article in International American Journal on “RP-HPLC Method Development and Validation on Fenoverine”. • Presented seminar on Method development and validation on Entacapone at Creative Educational college of pharmacy.