Profile Details

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USD 10 /hr

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Hire Dr. Anurag S.

India

USD 10 /hr

Pharmaceutical R&D (Formulation development and Analytical) expert, Medical, Science and Research Writing Expert

Profile Summary

• I am Anurag Sharma, I have completed my post-graduation on pharmaceutical science and PhD in pharmaceutical science with and more than 10yrs of professional experience working as a professional Pharmaceutical R&D expert. Taking lead of all pharmaceutical formulation activities, formulation and development, successful scale up and Technology Transfer , commercial launching, troubleshooting for existing and new products, Analytical support resolving queries, Addressing all Regulatory and BIO related queries for successful filing of product. below is the summary of work. Manufacturing plant set up with all cGMP norms and guidelines and with support of approved according to current regulatory guidelines. •Freelance 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

Subject Matter Expertise

• ★ Pharmaceutical Regulatory Affairs
• ★ Pharmaceutical Manufacturing
• ★ Pharmaceutical Process Development
• ★ Medical Writing
• ☆ Analytical Chemistry
• ☆ Deformulation
• ☆ Industrial Engineering
• ☆ Pharmaceutical Sciences
• ☆ Pharmacy
• ☆ Clinical Pharmacy
• ☆ Drug Development
• ☆ Extractable & Leachable Testing
• ☆ Clinical Trials
• ☆ Medical Sciences
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Clinical Study Reports
• ☆ Medical Content Writing
• ☆ Technical & Scientific Writing
• ☆ Science Communication
• ☆ Formulation
• ☆ Nutraceuticals
• ☆ Six Sigma

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Technical Writing

Research Market Research, User Research, Feasibility Study, Fact Checking, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Digital Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Big Data Analytics

Product Development Formulation, Recipe Development, Deformulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Concept Development, Prototyping

Work Experience

Assistant Manager/Manager

Thame Laboratories

July 2017 - Present

Team Leader

Amneal Pharmaceuticals

May 2015 - June 2017

Research Scientist

Alembic Pharmaceuticals

April 2012 - May 2015

Education

PHD in Pharmaceutical Science

Gujarat Technological University

June 2012 - August 2015

Certifications

• Certified Six Sigma Yellow Belt

  Board of Regents of the university system of georgia

  https://www.coursera.org/account/accomplishments/specialization/certificate/QHN9Z5NEBXD3

  February 2022 - May 2022