4 Product Claims Jobs

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 document review, consensus meetings, quality control, and document finalization under aggressive timelines. To be successful in this role, you should have experience in authoring different clinical document types supporting regulatory filings, including protocols, Informed Consent Forms, amendments, Investigator Brochures, and clinical study reports. You should possess strong communication skills, time management abilities, and be able to work independently while maintaining communication with the project manager. Your knowledge requirements include a strong understanding of regulatory guidelines/requirements, the ability to interpret data and apply scientific knowledge to support regulatory document writing, and familiarity with medical practices related to procedures, medications, and treatments for various disease states. Additionally, you should have expertise in MS Word, document management systems, and be capable of training writers/authors on templates, guidelines, and tools. As a Lead Medical Writer, you will lead cross-functional teams to develop agreed-upon scientific/medical content, manage work plans for individual and multiple-document delivery, and facilitate review meetings. You will also ensure adherence to processes and best practices defined by the Sponsor, research regulatory requirements to stay current in the regulatory landscape, and share best practices with the team. In summary, this role requires a combination of medical writing expertise, regulatory knowledge, strong communication skills, and the ability to work effectively in a cross-functional team to deliver high-quality regulatory documents within specified timelines.,

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 working at the exciting intersection of healthcare and technology. You will be mentored by some of the brightest minds in the industry, offering a global fast-track career opportunity to grow along with Indegene's high-speed growth. We are a purpose-driven organization that enables healthcare organizations to be future-ready, with customer obsession at the core of our operations. Our actions are bold, decision-making nimble, and work ethic industrious. **Must Have:** - **Education:** MBBS/PhD/MDS/BDS/MPharm/PharmD - **Experience:** 4 to 6 years experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5) - **Role Purpose:** Lead Medical Writer is responsible for the development and review of medical writing deliverables supporting the clinical regulatory writing portfolio and training junior writers. **Skills Required:** - Authoring various clinical document types supporting regulatory filings - Excellence in focused writing and editing following defined processes - Leading cross-functional teams to draft scientific/medical content - Understanding the clinical development process from program planning to submission - Effective time management, organizational, and interpersonal skills - Customer focus and ability to work independently while following structured processes - Ability to move across Therapeutic Areas to support business continuity - Develop, coordinate, and oversee work plans for multiple-document delivery - Facilitate review meetings, address feedback, and negotiate solutions **Knowledge Requirement:** - Strong scientific knowledge and understanding of regulatory guidelines - Ability to interpret data and apply scientific knowledge to support regulatory document writing - Manage messaging for consistency and alignment with the agreed-upon strategy - Comfortable working on cross-functional teams and providing insights based on previous experiences - Experience writing protocols, amendments, CSR, and CTD summary documents **Good to Have:** - Expert authoring in MS Word and understanding MS Word functionality - Experience working in document management systems and managing workflows - Flexibility in adapting to new tools and technology - Capable of training writers/authors on the use of templates, guidelines, and tools **Responsibilities:** - Prepare/review clinical study reports, protocols, investigator brochures, and submission data summaries - Apply lean authoring principles and coordinate document review activities under aggressive timelines - Develop and maintain project plans and work as an active member of cross-functional teams - Ensure adherence to standard content, lean authoring, and messaging across team members - Conduct literature searches and screening as needed - Share lessons learned, best practices, and ensure compliance with company training **Equal Opportunity:** Indegene is an equal opportunity employer dedicated to providing a diverse and inclusive workplace for all employees.,

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.,

Job Details: Designation: Senior Process Executive Job Level: JL 2A Job Location: Pune (Work from Office) Experience: 1-2 years Shift: UK Shifts Notice Period: Immediate to 15 Days Mandatory: Product Claim, Product Insurance and Insurance Selling Job Description: Candidate should have hands on knowledge of Product Claim & Product Insurance. Should be able to handle standalone activities and connect with business partner as n when required.