Sangeeta Saini

-Interact with client to manage and resolve customer requests

-Provides project updates

-Create/collate periodic reports for client meetings

-Independently manage more comprehensive document eg. CSR

-Mentor/coaches ad groom team members to grow

• Authoring/reviewing of regulatory reports such as protocol and CSR.
• Writing, editing, and finalizing narratives
• To provide training to the new employees
• Handling of team sheets related to projects and prepared the presentations for client purpose
• Therapeutic area: Oncology, respiratory, cardiovascular, metabolic disease

• Writing, editing, and reviewing of the Narratives (Client: Pfizer; Therapeutic area: Oncology and Metabolic).
• Writing/reviewing of clinical study reports
• Sound knowledge of all types of narrative hybrid, prose and automated narratives.
• Worked closely with manager and TL at all steps authoring to final submission of narrative and have sound knowledge of full process of narrative (involved authoring, reviewing, QC process, and TOC collation)
• Have experience of large narrative project (~4000) and handled projects as a senior member of team.
• Have experience of handling project independently and leading team.
• Have sound experience to handle team queries.
• Mentoring and training of the new Joiner.
• Other activities: handling of tracker per project and client requirement, led the internal team meetings for projects, involved in process improvement per client need.

• Writing, editing, and reviewing ICH compliant US and international regulatory submission following the AMA (American Medical Association) for writing style:
• Clinical study reports writing experience (Full CSR and Abbreviated CSR) and protocol.
• Patient safety narratives
• Write, edit, and review SmPC for submission in France authority
• Bibliographic research for writing SmPC
• Manuscript writing
• Therapeutic area: Cardiovascular

• Worked for cardiovascular and metabolic therapeutic area.
• To analyses and collect the data of clinical studies (Phase 1, 2, 3 and 4) from different sources for Pharma clients.
• Sources used such as ct.gov, PubMed, company sites, sec filing, country registries (UMIN, EUCTR etc), scientific journals and meetings.
• Mentoring of new joiner