We work closely with Medical Device companies, biotechnology companies, physicians and clinical scientists working in this field. We deliver effective, objective and credible medical writing for a wide range of audiences. We specialize in publications writing, regulatory writing, clinical writing and marketing communications. We have worked with several top ranking and start up companies. Our deliverables include manuscripts, white papers, clinical evaluation reports, post market surveillance reports, post market clinical follow up, clinical study protocol, IFU, SSCP.

● Managing Clinical submissions of 41 product portfolio for EU MDR by authoring, reviewing and responding to the queries on submission documents (CER, CEP, SSCPs, PSUR, PMCF report)● Overseeing Zimmer sponsored and investigator initiated clinical trials ● Providing input to set global clinical strategies for successful product launch● Synthesize, assess, and communicate potential impact of key findings to internal stakeholders● Review promotional material and provide clinical perspective● Serve as the clinical point person to develop and write credible medical content for a full range of deliverables including manuscripts, slide presentations, advisory boards, posters, strategy guides, and more. ● Review medical content for scientific accuracy and relevance.● Participate in advisory board meetings and steering committee meetings

● Involved in updating CERs on Cranial Mandibular Facial Thoracic (CMFT) implantable devices● Leading remediation efforts for deficiencies identified by notified bodies● Designing PMCF studies to meet MDR regulations● Involved in updating regulatory documents such as PMS reports, PSURs, IFUs● Assisted in writing protocols for clinical studies● Assisted in white paper drafting, conference abstract drafting, usability survey drafting

● Updated CERs on hemodynamic monitoring systems for MDR transitioning process for Class I, II and III medical devices● Conducted comparative gap analysis for identifying deficiencies in content alignment of CER, PSUR, SSCP, IFU and RMR● Lead efforts on remediating deficiencies identified by notified bodies

● Updated CERs on hemodynamic monitoring systems for MDR transitioning process for Class I, II and III medical devices● Conducted comparative gap analysis for identifying deficiencies in content alignment of CER, PSUR, SSCP, IFU and RMR● Lead efforts on remediating deficiencies identified by notified bodies

I offer effective communication solutions and network building essential for driving businesses forward by making connection and increasing visibility.-Building network-Content development for websites and improving SEO-Help with writing grants

Writing Clinical Evaluations Reports for Zimmer Biomet’s medical devices. Actively involved in responding to BSI queries.

Medical and Healthcare marketing writing.

Responsible for drafting technology opportunity sheets, conducting prior art searches for technologies, seeking commercial development partners in areas of Healthcare and Biomedical research.

Working on identifying novel Mechanotransduction pathways for vinculin and cadherin, using FRET based molecular tension sensors.Experience with mouse models of congenital diseases, cell culture techniques, microscopy, advanced cloning techniques such as overlap extension and Gibson assembly.Currently utilizing all these techniques to gain better understanding of mechnotranduction pathway.

• Conducted Cell and Developmental Biology discussion sessions for Pre Med students• Delivered lectures for specific cell and developmental biology topics such as signaling pathways• Designed and Graded Exams

Prepared sample IND and IDE for FDA submissionParticipated in workshops for Regulatory affairs

TEACHING INSTRUCTOR• Instructed 25 freshmen students in “Molecular Biology” lab.• Successful application of innovative teaching technique, like learning through making brochures and presentations for congenital diseases such as lysosomal disorders, Down’s Syndrome, thalesemia, • Evaluated their presentations and advised on improving presentation skills.

• Mentored “Introductory Biology” lab to 2 batches of 25 freshmen each.• Lectured and demonstrated enzymatic and immunoassays in the lab to students.• Designed exams and graded quizzes, exams and presentations.

Worked on designing a novel PCR based diagnostic assay for HIV early detection. Team leader for diagnostic team. Mastered skills such as ELISA, PCR, Dot test.

Internship in Quality control department. Succesfully learnt the process of Batch fermentation.

Worked in Quality control department. Hands on experience with Antibiotic assay, HPLC, GC.