Amardeep JAISWAL

Ø Created content and visuals for product marketing and training initiatives within the pharmaceutical sector.

Managed real-world evidence projects across multiple therapeutic areas, including literature searches.

Supported medical writing activities for physicians by preparing clinical reports and manuscripts.

Delivered lectures on pharmacology at universities, enhancing educational engagement.

Led projects in oncology, cardiology, autoimmune disease, neurosciences, and rare diseases fields.

· Led writing team delivering clinical documents for Pharma products and unmet medical needs.

· Reviewed clinical data trends of clinical trials and observational studies, and prepared reports.

· Conducted Systematic Literature Reviews (SLRs), Targeted Literature Review (TLRs), and Evidence Generation supporting to prepare Health technology assessment (HTA) document.

· Executed comprehensive quality check (QC) of clinical documents in all development stages.

· Developed a framework of approved products as orphan drug status from FDA for decision making.

· Provided regular updates for project status to management in leadership meetings.

· Conducted Project Management activities like people managingment, resource allocation, problem solving, manage project timelines, risk identification, negotiation and project tracking.

· Authored and reviewed clinical safety narratives, CSRs, Investigator Brochures (IBs), Clinical overview and summary tables of clinical studies.

· Led client communications ensuring timely document delivery throughout project lifecycle.

· Supported business development initiatives by sharing domain expertise.

· Authored, reviewed and contributed to CSRs, Observational study reports, study protocols/ amendments, SAP, ICFs, IBs, BLAARs, and clinical trial summaries.

· Conducted Quality Review (QC) of CSRs to ensure compliance with as per ICH E3 guidelines.

· Actively contributed to Clinical Trial Team (CTT) supporting documentation for assigned projects.

· Collaborated with Clinical Trial lead to discuss trial timelines, protocol amendments etc.

· Drove management of seasonal CSR’s narrow timelines as per regulatory submission strategy.

· Functioned as point of contact for contract writers, for outsourced safety narrative development

· Facilitated collaboration with Publication teams contributing to publication planning.

· Cross-functional collaboration: With Clinical, Regulatory, Safety, and Biostatistics teams.

· Prepared CSRs, manuscripts, posters, slide decks, and SOP-aligned training materials.

· Partnered with hospitals managing patients’ data to generate publications.

· Provided therapeutic area training to associates for developing medical writing documents.

· Collaborated with Data Management to design case report form (CRFs) and align with protocol-driven data collection needs