Superna Dumbala

● Drafted, reviewed, and edited a wide range of complex clinical documents, including Clinical Development Plans (CDPs), study outlines, and Investigator’s Brochures (IBs), ensuring scientific accuracy, regulatory compliance, and alignment with strategic objectives. ● Collaborated cross-functionally with clinical, regulatory, safety, and biostatistics teams to ensure clarity, consistency, and timely delivery of high-quality documents.

● Reviewed, edited, and performed quality control (QC) of clinical and regulatory documents in alignment with CRISPR’s objectives, style guides, and compliance checklists. ● Led medical writing efforts for immuno-oncology programs, with a focus on CRISPR/Cas9-edited allogeneic CAR-T cell therapies. ● Collaborated cross-functionally with study teams to develop key regulatory documents, including IB, development safety update reports (DSURs), clinical trial protocols, risk-benefit assessments (RBAs), clinical study reports (CSRs), and others.

● Planed and coordinated report-writing activities with other functions, including Clinical Operations, Pharmacovigilance, Regulatory and other groups. ● Developed new SOPs and revised existing SOPs to ensure compliance with GCP guidelines, internal quality standards, and inspection readiness expectations. ● Collaborated cross-functionally to identify process improvement opportunities and recommend enhancements to efficiency and effectiveness.

● Worked independently authoring a variety of documents that included but not limited to CSR, investigator's brochure, safety narratives, style guides and submission documents, such as IND components and/or NDA components (clinical/nonclinical summaries and overviews). ● Participated in the initial scoping of new projects and attended project kick-off meetings. ● Reviewed SAP and tables, figures and listings (TLFs) to ensure appropriate data presentation for CSR purposes. Provided feedback on SAP and TFLs to project team as needed. ● Checked electronically published CSRs for completeness (including Section 16 appendices) and adherence to company’s electronic publishing standards. ● Interacted closely with clients to meet their medical writing objectives and timelines. Functions included planning of medical writing strategies in close association with client project goals. ● Performed document reviews, editing, and quality control (QC) as per client objectives/expectations, style guides and checklists. ● Adhered to established regulatory standards, including but not limited to International Conference on Harmonization (ICH) -E3 guidelines, as well as company SOPs, client standards, and company and/or client approved templates and style guides when completing medical writing projects, on-time and on-budget. ● Contributed to the foundation of the Medical Writing Practice through drafting internal processes / SOPs. ● Supported business development and marketing efforts that pertain to medical writing. ● Developed Life sciences training material on global regulatory landscape.

● Prepared, edited, and finalized CSRs, CTD clinical summary, briefing package, IND applications, breakthrough designation report, immunogenicity report and other clinical trial documentation as necessary for submission to the FDA or other regulatory agencies or for in company use. ● Participated in scientific communication planning, including development of strategic medical communication plans. ● Partnered with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded TFLs, and narrative planning for relevant documents. ● Worked closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources. ● Scheduled and conducted document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes. ● Collaborated with clinical scientists, safety scientists, biostatisticians, and pharmacokinetics to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents. ● Managed the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed. ● Managed all aspects of outsourced or internal CSR production and ensures project delivery. ● Ensured that medical writing deliverables conform to ICH and other relevant regulatory guidelines ● Created and maintained standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables. ● Ensured that appropriate documented QC checks are performed on medical writing deliverables, responds to findings, and recommend quality process improvement. ● Ensured documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system.

● Authored, edited and co-coordinated preparation of Clinical Study Reports (CSR) end to end including preparation of CSR shell. ● Participated in review of analysis plan and advise on required tables. ● Reviewed SAP and tables, figures and listings (TLFs) to ensure appropriate data presentation for CSR purposes. Provided feedback on SAP and TFLs to project team as needed. ● Developed and maintained effective working relationships among document contributors on multifunctional platforms. ● Ensured reviewers and other contributors are identified and can perform tasks according to the agreed process. ● Ensured CSR process is completed according to SOP within the time specified by the SOP or otherwise agreed with the team, whichever is shorter. ● CSR tracking and status reporting, including identifying milestone timelines. ● Developed both the CSR process and product to match changing business needs.

● Performed Medical Writing activities on the clinical/regulatory documents such as Clinical Trial Protocols, Manuscripts, Investigator's Brochure (IB), Informed Consent Form. ● Developed and maintained necessary templates, formats and style guides to ensure that documents generated meet client requirements. ● Performed quality control checks/peer review as and when specified. ● Performed any other related activities assigned by the supervisor, such as the documentation of deliverables/ deadlines/ queries raised to the client etc. ● Authored fixed dose combination (FDC) documents; periodic updates of development safety update report (DSUR). ● Comprehensive literature/information searches both externally and internally. ● Coordinated with other disciplines e.g., Safety Assessment and Chemistry manufacturing and controls. ● Authored/reviewed tabular data summaries and study listings. Medical Information Queries: ● Provided timely, accurate and relevant medical / scientific information to internal and external customers. ● Weekly literature searches on specified products according to local procedures to identify any new clinical information.

• Recorded third party information in database and fill out forms. • Associated with the development of Third Party Community website.

• Dispensed prescription drugs. • Used dispensary and stores computer systems to generate stock lists and labels. • Supported the pharmacist with their work and ensuring that prescriptions are legal, accurate, without any errors. • Responding to telephone and face to face enquiries of a routine nature from patients.

• Scientific database development covering chemical and biological spaces from various Journals and Patents. • Data-mining includes annotation of chemical, biological, pharmacological and toxicity information from patents, journals or targets. • Worked on Medicinal Chemistry Databases, Target Databases and Molecule centric Databases.