Assistant Manager - Quality Assurance & Medical Writing

About the job

Company Description C.L.A.I.M.S. Private Limited is a Clinical Research Organization specializing in safety and efficacy testing for cosmeceutical, dermaceutical, nutraceutical, and OTC products focused on skin, hair, and body care. The company combines scientific expertise with consumer insights to select appropriate measurement parameters based on product formulations, offering comprehensive and tailored testing solutions. C.L.A.I.M.S. is recognized for its professional and ethical approach to managing and conducting clinical trials. The organization collaborates closely with clients to support product claims and regulatory requirements, helping brands build trust through evidence-based results. Role Description The Assistant Manager Quality Assurance & Medical Writing is a full-time, on-site role based in Mumbai. This role is responsible for supporting and overseeing quality assurance activities related to clinical studies, including documentation review, and adherence to internal SOPs and regulatory guidelines. The Assistant Manager will prepare, review, and edit medical and scientific documents such as study protocols, informed consent forms, clinical study reports, and product claim substantiation documents. Ethics Committee submission of documents and presentation of studies, Translate clinical data into clear, structured CSR, Overseeingactivities of QC Department, Ensure accuracy, consistency, and GCP compliance at all trial sites, Manage timelines without compromising quality. Role also involves being a part of External and Internal audits. Qualifications

• Quality assurance knowledge in a clinical research or healthcare setting, with familiarity in SOPs, GCP, and regulatory or ethical guidelines.
• 3-4 years of experience in Medical Writing within a CRO.
• Excellent written English communication skills. & Effective communication and collaboration skills for working with cross-functional teams and external stakeholders.
• Proficiency in common office and documentation tools (e.g., MS Word, Excel, PowerPoint) and comfort with electronic data and document management systems.
• Ability to work on-site in Mumbai, and maintain high ethical and professional standards.
• Educational background in Life Sciences, Pharmacy, or a related discipline preferred.
• Strong attention to detail with the ability to maintain accuracy and consistency in documents.
• Well-organized and capable of managing multiple documents, projects, and deadlines simultaneously.

Who can apply

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