9 Investigator Brochures Jobs

Role Overview: You will be responsible for 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. Your role will also involve leading cross-functional teams, understanding the clinical development process, and possessing effective communication, time management, organizational, and interpersonal skills. Key Responsibilities: - Prepare and review clinical study reports, protocols, investigator brochures, submission documents, and other regulatory documents on investigational drugs in various stages of clinical development. - Ap...

The Medical Writer will be responsible for preparing high-quality clinical, regulatory, and scientific documents that support drug development and regulatory submissions. Roles & Responsibilities: Draft, review, and finalize clinical study protocols, investigator brochures, informed consent forms, and clinical study reports (CSRs). Prepare regulatory submission documents (CTD modules, IND, NDA, MAA dossiers). Write manuscripts, abstracts, and posters for publication/presentation. Ensure compliance with ICH-GCP, FDA, EMA, CDSCO, and other regulatory authority guidelines. Collaborate with clinical, pharmacovigilance, regulatory, and biostatistics teams. Perform literature search and develop su...

As a Lead Medical Writer, you will be responsible for developing and reviewing medical writing deliverables that support the clinical regulatory writing portfolio. Your role will also involve training junior writers. You must have 4 to 6 years of experience in writing Clinical & Regulatory documents supporting global filings, specifically with experience in CTD Module 2 and Module 5. Your responsibilities will include preparing/reviewing clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents on investigational drugs at various stages of clinical development. You will apply lean authoring principles and coordinate activities for do...

You are a technology-led healthcare solutions provider, driven by the purpose to enable healthcare organizations to be future-ready. You offer accelerated global growth opportunities for individuals who are bold, industrious, and nimble. At Indegene, you can experience a unique career journey celebrating entrepreneurship, guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, visit www.careers.indegene.com. Imagine moving to an exciting role in an entrepreneurial organization without the usual risks associated with it. At this stage of your career where growth and variety are important to you, Indegene inv...

We are a technology-led healthcare solutions provider driven by the purpose to enable healthcare organizations to be future-ready. We offer accelerated global growth opportunities for talent that is bold, industrious, and nimble. At Indegene, you will gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. If you are looking to explore exciting opportunities at the convergence of healthcare and technology, visit www.careers.indegene.com. Jump-start your career with Indegene where we understand the importance of the first few years in shaping your professional journey. We promise you a differentiated career experience ...

You will be responsible for providing support for medical safety management within the Patient Safety & Pharmacovigilance department. This includes conducting medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co-authoring safety documents, and assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Your role will involve creating quality deliverables within agreed timeframes and maintaining a high standard of accuracy in compliance with patient safety business rules, standard operating procedures, and global and local regulatory requirements. Additionally, you will be supporting in definin...

As a Medical Writer II specializing in QC of Regulatory Documents at Syneos Health, you will be responsible for compiling, writing, editing, and coordinating medical writing deliverables that present scientific information clearly and accurately. Your role will involve working within and across departments with minimal or moderate supervision to complete a variety of documents such as clinical study protocols, clinical study reports, patient narratives, investigator brochures, and more. You will adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures, while completing medical writing projects on time and within budget. Additionally, y...

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 ski...

Regulatory Affairs Manager in Clinical Research @ Vimta Labs Ltd, Hyd Experience: 8-12 years of Regulatory Affairs experience in Clinical Research Industry. CTC: Based on their current CTC. Job Description Regulatory Affairs Manager Primary Responsibilities: 1.. Manage the activities of Regulatory Affairs for clinical research and ensure the implementation of effective regulatory strategies. 2. CDSCO, CBN and NCB getting approvals as required for Vimta. 2. Provide regulatory input to strategic decision making; including prioritization, and external communications 3. Provide regulatory input to in-licensing evaluations and due diligence activities 4. Provide advice about regulations to manufa...