Applications are invited for Medical Writer positions at Institute of Good Manufacturing Practices India

Institute of Good Manufacturing Practices India, registered as a non-profit society with Government of India and a member (as a higher/professional education Institute) of Quality Council of India (QCI), Government of India -presents unique, friendly and interactive platform to get rid of all your GMP related glitches. GMP- is an essential and most dynamic element of industries like Pharmaceutical, Biotechnology, Cosmetic, Ayurveda, Homeopathy, Medical device and Food manufacturing. Keeping self-updated with current GMPs thus becomes inevitable to stay abreast with the changing industry needs and practices. With its mission of "Knowledge Dissemination and Human Resources Development in pharma and healthcare Industries", IGMPI is moving hand in hand with technology advances and has gained recognition as stronger and better training & distance learning platform provider for pharma and healthcare professionals and students in the a reas of Good Manufacturing Practices, Quality Assurance & Quality Control; Regulatory Affairs, Intellectual Property Rights, Clinical Research, Pharmacovigilance, Nanotechnology Medical Writing, Medical Coding, Drug Discovery and Development, Public Health and Hospital Management, Pharma Marketing and Pharma Product Management. The courses have been structured and designed under the guidance of field experts and thus promise to impart theoretical and practical knowledge about the defined subjects. Based on high standard of quality, the training programmes have been duly approved and certified by Quality Council of India, Government of India.

Post: Medical Writer

Job Description
1. Responsible for creating and reviewing medical documents that provide accurate details about medical information and products.
2. Prepare regulatory documents related to the approval of pharmaceutical and medical products in liaison with government regulation agencies.
3. Coordinate with various technical professionals, doctors and researchers to gather, organize and compile information on new products or processes.
4. Manage the writing, editing and reviewing of diverse regulatory & clinical documents including clinical study reports (CSRs), study protocols, investigator brochures, informed consent forms, clinical data summaries and other medical/regulatory documents (including regulatory summary documents).
5. Perform literature searches/reviews as necessary to obtain background information for development of documents.
6. Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and important advances in therapeutic areas for which the company focuses its educational programming and proposals for grant funding.
7. Performs quality control (QC) checking / proof reading of, abstracts, posters, slide sets and other scientific resources to meet customer expectations.
8. Format manuscripts to meet journal submission requirements.
9. Represent medical writing on project teams through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments.
10. Contribute scientific knowledge, analytical skills, experience, and insight to the analysis of data, the preparation of documents and reports, and the production of registration dossiers.
11. Ensure that accurate and high-quality documents are prepared in compliance with ICH and CDSCO guidelines.
12. Ensure medical/scientific consistency between related documents (i.e. submissions and publications).

Candidate Profile
1. Ability to understand and interpret data/information and its practical application.
2. Excellent written/oral communication skills.
3. Strong understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, project management and medical terminology.

Additional Information:
Experience: 1-5 years
Education: MBBS/M. Pharm/PhD/ B.H.M.S/B.A.M.S/B.D.S/M.Sc Clinical Research
Location: New Delhi/NCR
Job Type: Full Time
Employment Type: Permanent
Fuctional Area: Medical writer
End Date: 15^th December, 2014