Medical Writer / Clinical Research
Lincoln Pharmaceuticals Ltd.
1 - 4 yrs
Ahmedabad
Job Description
- 1. Medical Writing Activities:
- Prepare and review of all study documents like Protocol, Case Report Form, Informed Consent Form, Investigator Brochure, Therapeutic Justification, clinical study Report, etc.
- Prepare Package inserts, Therapeutic Rationale, Motivational Letter, etc. for IRA department and regulatory
- Prepare statistical Report and assist Clinical research Associates (CRA) in preparation of BE study report for IRA department
- Prepare Standard Operating Procedures for the Department
- Preparation of Periodic Safety Update Reports(PSURs) as a part of Pharmacovigilance
- Prepare and Submit Manuscript for Publication in National & International journals
- Prepare specific query reply letters, Presentation or documents for IRA and Marketing Department
2. Regulatory activities:
- Prepare and submit dossier for New drug permission from DCGI& checking daily updates on CDSCO website.
- Prepare and Submit dossier for Import Permission of Bulk drugs
- Prepare and Submit PSURs for all DCGI approved drug products
- Prepare Executive summary, Presentation and 11 sets of technical literature for New Drug Advisory Committee (NDAC)
- Do follow-ups and query response related to New drug submission for DCGI
- Prepare documents related to State FDA permission of generic drugs
- Do Presentation at NDAC meeting of DCGI.
3. Pre-clinical & Clinical trial planning & conduct activities:
- Contact CRO for quotations & co-ordination for study related activities
- Involved in the designing and planning of pre-clinical, clinical and post-marketing surveillance trial
- Review BA/BE study Protocols, preclinical study protocol, BA/BE study report, preclinical study report and other documents related to clinical development of product and do follow-ups for the same
- Assist CRAs in identification of pre-clinical study sites and Clinical trial Study sites
- Prepare Study Budget
- Review Ethics committee submission dossier, Trial Master File and Sponsor files
- Conduct study site and study investigator visit for Ahmedabad and nearby region
- Ensure the project is progressing according to quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations
4. Training Activities:
- Train CRAs on study protocol, SOPs or other applicable documents.
Company Profile:
Lincoln Pharmaceuticals Ltd.
Lincoln Pharmaceuticals Limited is one of the fastest growing players in Pharmaceutical Industry focusing on Generics & Specialty products, providing products to customers in more than 50+ countries and territories.
The company maintains one of the industry" broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline.
With a workforce of more than 1000, Lincoln has attained leading positions in key Semi Regulated Markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service.
The Manufacturing Facility is approved by WHO-GMP, ISO-9002 and other Semi Regulatory Approvals and aiming to get Regulatory Approvals such as MHRA, EU-GMP, TGA and USFDA for both Solid Dosage Forms & Small Volume Injectables (SVPs) in nearest future.
The company maintains one of the industry" broadest and highest quality product portfolios, which is regularly bolstered by an innovative and robust product pipeline.
With a workforce of more than 1000, Lincoln has attained leading positions in key Semi Regulated Markets through its wide array of dosage forms and delivery systems, significant manufacturing capacity, global commercial scale and a committed focus on quality and customer service.
The Manufacturing Facility is approved by WHO-GMP, ISO-9002 and other Semi Regulatory Approvals and aiming to get Regulatory Approvals such as MHRA, EU-GMP, TGA and USFDA for both Solid Dosage Forms & Small Volume Injectables (SVPs) in nearest future.
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