Anurag S.

• I am Anurag Sharma, working as a professional medical and science writer. I have completed my post-graduation on pharmaceutical science and PhD in pharmaceutical science. with and more than 9yrs of professional experience below is the summary of work • Serves as medical writing lead on more complex or clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Publications or Regulatory team(s) on document strategies. Implements all activities related to the preparation of (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical. • Manage the review and approval process of clinical submissions documents, writing documents, generating consensus among reviewers, and facilitating discussions. Provide process, content, and submission document planning to the Clinical Submission, Clinical Satellite and Clinical Trial Teams. Advising on resource utilisation, efficiencies and timelines • Perform literature searches/reviews and research current guidelines as necessary to gather background information and training for development of documents • Contribute to the development of frameworks, modules, templates, and general guidelines for IRCs, reviewer manuals, and imaging CRFs • Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook) • Able to quickly acquire working knowledge regarding a variety of scientific/medical fields • Basic knowledge of statistics, basic data interpretation and presentation skills • Detail-oriented. Methodical. Goal-driven. Good judgment. Able to work with minimal supervision • Good knowledge of regulatory documentation and drug development process • Good interpersonal skills. Ability to work within a team • Knowledge of medical terminology and basic statistical/clinical concepts • Competence in completing good first draft technical reports or clinical reports within a reasonable timeframe with limited guidance • Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups • Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability