Mayank Singh
Clinical Research Writer | Protocol, ICF, CSR, CRF, IB | ICH-GCP, GDP, NDCT Rule 2019
- Role
- Medical Writer Ii at Alpha MD
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Mayank Singh
As a Medical Writer, I applied my clinical research and good clinical practice (GCP) skills to produce high-quality documents for various pharmaceutical and biotechnology clients. I worked with CLINICA Research Solutions LLP, a leading contract research organization, for over a year, where I contributed to the development of multiple investigator\'s brochures (IB), protocols, and reports. I also supported the regulatory submissions and publications of several clinical trials. With a master\'s degree in pharmacology from Oriental Education Society\'s College of Pharmacy, I have a strong background in the scientific and ethical aspects of drug development and research. I am passionate about advancing the knowledge and practice of pharmacology and improving the health outcomes of patients. I am looking for new opportunities to leverage my medical writing skills and expertise in a dynamic and collaborative environment.
Experience
Medical Writer Ii
Sep 2023 — Present · Mumbai, IN
Prepare and finalize clinical trial documents (protocols, ICFs, IBS, synopses, reports, CRFs, abstracts, posters, presentations). Develop scientific and marketing content (LBLs, case studies, guidelines, CME slide decks, KOL cases, Patient education). Ensure compliance with ICH-GCP, SOPs, and client requirements. Collaborate with cross-functional teams and manage document reviews. Review for clinical documents and mentor junior writers. Support process improvements and handle multiple projects. Experience in literature search and systematic review
Education
Oriental Education Societys College of Pharmacy Sanpada Navi Mumbai
Master's degree
2020 — 2022
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