Lead - Scientific Writing Indegene
Indegene
Office Location
Full Time
Experience: 10 - 10 years required
Pay:
Salary Information not included
Type: Full Time
Location: Karnataka
Skills: Medical Writing, protocols, Investigator Brochures, data interpretation, Time management, Interpersonal Skills, People Management, Customer Focus, Workflow Management, Clinical Regulatory documents writing, Clinical Study Reports, amendments, ICFs amendments, Product claims, Clinical trial design, Scientificmedical content drafting, Crossfunctional Team Leadership, Organizational Skills, Therapeutic Areas knowledge, Work plan development, Adherence to processes, Regulatory guidelines knowledge, MS Word authoring, Document Management Systems, Training on templates, Tools
About Indegene
Job Description
You should have MBBS/PhD/MDS/BDS/MPharm/PharmD education qualification with 10 to 12 years of experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5). As a Medical Writer, your role will involve handling complex Medical Writing projects, providing review support for medical writing deliverables, training junior writers, and authoring a broad set of different clinical document types that support regulatory filings. You should have demonstrated excellence in focused/lean writing, lead cross-functional teams, understand the clinical development process, and possess effective communication, time management, organizational, and interpersonal skills. People management experience for more than 2 years is required along with the ability to work independently while maintaining communication with the Sponsors MW project manager. Your responsibilities will include preparing/reviewing clinical study reports, protocols, investigator brochures, submission documents, and other regulatory documents on investigational drugs in various stages of clinical development. You will apply lean authoring principles, coordinate document review activities, develop project plans, and work as an active member of cross-functional teams representing Medical Writing. Conducting literature searches, participating in department initiatives, researching regulatory requirements, and ensuring compliance with company training are also part of your responsibilities. You should have strong knowledge of regulatory guidelines/requirements, the ability to interpret data, apply scientific knowledge to support regulatory document writing, manage messaging for consistency, and provide insight based on previous experiences. Additionally, expertise in MS Word, document management systems, eApproval/signatures, and adaptability to new tools and technology are required. Capable of training writers/authors on the use of templates, guidelines, and tools is also essential for this role. This position is based in Bangalore, KA, IN.,