Raleigh-Durham-Chapel Hill Area
I translate my scientific, clinical, regulatory, and communication expertise into healthcare decisions and patient outcomes. I am a Scientific/Medical/Regulatory communication professional and medical/scientific engagement leader within pharma, biotech, and CRO, leveraging my scientific communication, regulatory knowledge, and collaboration skills to transform human health. My expertise spans scientific communications, medical/regulatory affairs, compliance, clinical research, project management, stakeholder engagement, and cross-functional collaboration, including writing over 100 scientific, regulatory, and clinical documents; 61 high-impact manuscripts; 42 abstracts/posters; 4 reports; and 4 grant applications, including grants from top pharma. I work at the intersection of clinical documentation, study operations, regulatory strategy, and internal/external scientific exchange within global study teams. I understand how protocols, investigator brochures, CSRs, and study reports support study delivery, site activation, compliance, and cross-functional decision-making across Clinical Operations, Data Management, Biostatistics, Medical, and Regulatory stakeholders. In addition, I have the following qualifications: Robust background in Clinical Trials, Drug Development, Scientific/Medical/Regulatory Writing, Project Management, Regulatory Affairs, and Global Study Team collaboration with experience in Clinical Microbiology, Antibacterial Drug/Device/Vaccine/Diagnostic Discovery. AI enthusiast with continuous education in Regulatory Affairs/Regulatory Writing through NCRAF/AMWA. Expert in preclinical animal models and related regulations. An adept science communicator with over 10 years of experience translating scientific concepts for multidisciplinary audiences, building trust with peers, collaborators, customer-facing teams, healthcare professionals, and regulators. I have written scientific, regulatory, and clinical documents; developed protocols; authored grants, science blogs; and delivered oral/poster presentations at meetings. Recognized as a problem solver with emotional intelligence, professional awareness, change agility, delivery mindset. Detail-oriented, creative, and self-directed, with the ability to solve problems and build strong cross-functional relationships across global study teams, field medical, and external scientific stakeholders. Skilled in prioritization under pressure, maintaining team alignment across multiple parallel projects, organizing departmental and community efforts, and supporting hiring and team development.
Author, review, and standardize regulatory SOPs, templates, style guides, and workflow documentation, ensuring consistency, traceability, and compliance with ICH, GCP, GLP, and GxP requirements across internal and client-facing deliverables. Support development and QC of core regulatory documents, including clinical study protocols (CSP), investigator’s brochures (IBs), clinical study reports (CSRs), and related documentation, contributing to submission-quality outputs. Optimize regulatory medical writing processes and innovation, supporting process audits and the evaluation of AI-enabled tools to enhance document quality, compliance, and workflow efficiency.
Independently author/edit/review a broad range of scientific, clinical and regulatory documents: Assay Protocols, SOPs, Qualification/Validation/Transfer/Investigation/Bioanalytical Reports etc., keeping abreast of current medical writing/regulatory knowledge. Contribute as needed and work collaboratively in authoring/editing/reviewing more complex regulatory and clinical documents. Assist/train other team members in authoring/managing documents. Stay updated with current healthcare industry trends, documentation practices, pharmaceutical industry practices, and global regulatory requirements through internal/external training and continuing education. Perform internal document reviews, editing, QC, and provide inputs, finalize the documents, coordinate the documents approval, and manage the documents in document management systems like Smartsolve and ELVIS routinely. Work collaboratively and lead the efforts with laboratory scientists, project leads, project managers, QC etc. and external customers to produce quality reports on time and within the full compliance of regulatory agencies. Attend project team meetings, participate in/lead comments resolution or similar meetings with external customers. Complete project finance activities, including monitoring and forecasting budgeted hours. Manage day-to-day workload such as identifying and prioritizing project needs, tracking timelines, implementing customer requests, and contributing to and facilitating client meetings etc.
Served as the Lead Scientist / Scientific and Regulatory contact and managed day-to-day operations of a Clinical Research Laboratory specializing in antimicrobial drug/device/vaccine/diagnostics discovery and clinical trials. Developed, wrote, reviewed, and maintained bioanalytical study protocols. Wrote, maintained, and assisted with IRB protocols. Wrote/assisted with Investigator's Brochure (IB), Patient Narratives, Clinical Summaries, Clinical Study Protocol (CSP), and Clinical Study Report (CSR) as a subject matter expert (SME). Wrote successful grants to sustain active Clinical/Translational studies. Fostered external/ internal cross-functional collaboration. Wrote/edited/published high impact manuscripts using data from clinical trials; presented in conferences; won awards, peer reviewed manuscripts for prominent journals. Managed clinical data collection, data entry [Case Report Form (CRF), Informed Consent Form (ICF)] etc. Collaborated with Clinical Research Coordinators and Clinical Investigators in managing/processing clinical specimens and data from different phases of Clinical Trials. Wrote and maintained pre-clinical IACUC animal use protocols including adverse event reporting, annual report submission, protocol amendment, etc. ensuring full compliance of IACUC/AAALAC. Mentored Undergraduate/Medical students/Clinical fellows/Technicians, facilitated writing/editing of Study Plans/Protocols/Lab Reports. Provided oversight of laboratory operations, facilitated scientific literature evaluation, and aided in data analysis and interpretation. Managed the writing, editing, and presentation of manuscripts, SOPs, reports, theses, dissertations, and abstracts. Conducted performance evaluations of lab personnel. Regulatory point person for the use of controlled substances in pre-clinical animal studies. Wrote and maintained the control substance licensure (submission, renewal etc.) complying with the regulations of federal, state and local agencies.
Serve as a subject matter expert (SME), resource person and lead writer for a global sales and marketing team in the areas of Infectious Disease and Microbiology. Work closely with the regulatory and compliance team in determining and authoring relevant topics and “White Paper” content to share with their Infectious Disease audience and client base at Acutis Diagnostics. Developed, wrote, reviewed, and maintained bioanalytical study protocols in Microbiology and Infectious Diseases. Designed/Executed/Managed experiments. Wrote/edited high impact manuscripts; presented in conferences; peer reviewed manuscripts for prominent journals; Wrote and assisted in writing successful grants; provided scientific support to other members of the lab at Duke University Medical Center, University of Nebraska Medical Center, Nepal College Teaching Hospital, SACTS and LEADERS Nepal. Wrote textbook and book chapter at Duke University Medical Center, Nepal Medical College Teaching Hospital and Kathmandu Medical College Teaching Hospital. Cross-functional collaboration with internal/external investigators and Pharmaceutical sponsors in Clinical/Translational research focusing on Drug/Device/Vaccine/Diagnostic discovery at Duke University Medical Center. Presentation (Business as well as class-room settings) on several pharmaceutical products (Drugs and Biologics) to Clinicians, Nurses, Pharmacists, and KOLs at SmithKline Beecham Pharmaceuticals (Currently GSK). Authored successful grant proposals, wrote project reports and collaborated with international funding agencies at SACTS. Wrote SOPs and protocols; trained laboratory technicians, undergraduate students, and eco-club members; developed research proposals and project reports; worked closely with international funding agencies and obtained successful grants; developed relationship with key opinion leaders and institutions through peer-to-peer interactions and cross-functional collaboration at LEADERS Nepal.