Job
Description
As a Medical Writer, you will be responsible for preparing medical writing documents for fresh and renewal filings within defined timelines. Your key responsibilities will include: - Preparation of various Medical Writing Documents such as Labels, Prescribing Information, Summary of Product Characteristics, Patient Information Leaflet, Medication Guides, Expert Reports including Clinical Expert Reports, Nonclinical Expert Reports, Medical Data Package, and Annual Report for US NDA. - Supporting R&D departments and Business throughout the drug product life cycle & 505(b)(2) projects by preparing Medical Rationales, Therapeutic Justifications, Bio-recommendations, Bio-waivers, Bio-reports, and other assigned project write-ups. - Handling Pre-IND, IND, NDA documents, Initial Pediatric Study Plans, Labels, and providing medical support during development and filing phases. - Contributing to new product proposals and evaluations. You will also be responsible for maintaining Quality Standards and participating in necessary trainings, ensuring compliance to SOPs and regulatory guidelines, and striving for zero critical errors in documents as per quality metrics (QM). Additionally, you will attend and conduct assigned training sessions for the team. Qualifications required for this role include: - Masters degree in Life Sciences, Pharmacy, Medicine, or related field. - Proven experience in medical writing for regulatory submissions. - Strong understanding of global regulatory requirements such as US FDA and EMA. - Excellent written and verbal communication skills. - Attention to detail and ability to manage multiple projects simultaneously. As a Medical Writer, you will be responsible for preparing medical writing documents for fresh and renewal filings within defined timelines. Your key responsibilities will include: - Preparation of various Medical Writing Documents such as Labels, Prescribing Information, Summary of Product Characteristics, Patient Information Leaflet, Medication Guides, Expert Reports including Clinical Expert Reports, Nonclinical Expert Reports, Medical Data Package, and Annual Report for US NDA. - Supporting R&D departments and Business throughout the drug product life cycle & 505(b)(2) projects by preparing Medical Rationales, Therapeutic Justifications, Bio-recommendations, Bio-waivers, Bio-reports, and other assigned project write-ups. - Handling Pre-IND, IND, NDA documents, Initial Pediatric Study Plans, Labels, and providing medical support during development and filing phases. - Contributing to new product proposals and evaluations. You will also be responsible for maintaining Quality Standards and participating in necessary trainings, ensuring compliance to SOPs and regulatory guidelines, and striving for zero critical errors in documents as per quality metrics (QM). Additionally, you will attend and conduct assigned training sessions for the team. Qualifications required for this role include: - Masters degree in Life Sciences, Pharmacy, Medicine, or related field. - Proven experience in medical writing for regulatory submissions. - Strong understanding of global regulatory requirements such as US FDA and EMA. - Excellent written and verbal communication skills. - Attention to detail and ability to manage multiple projects simultaneously.
