6 Investigator Brochures Jobs

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 invites you to join their journey and grow with them. Indegene provides roles that offer both excitement and reliability, trusting you from day one to deliver global impact, lead teams, and take responsibility for outcomes while being supported and mentored by leaders. As a profitable rapidly growing global organization, Indegene is seeking the best talent for its current phase of growth. Working at the intersection of healthcare and technology, you will have access to global opportunities with fast-track careers, collaborating with a purpose-driven team. This combination promises a truly differentiated experience for you. If this opportunity excites you, apply for the position of Associate Manager / Manager - Regulatory Writing (Clinical) at Indegene. **Experience:** You should have 10 to 12 years of experience in writing Clinical & Regulatory documents supporting global filings, specifically CTD Module 2 and Module 5. **Role Purpose:** Your role involves handling complex Medical Writing projects, providing review support for medical writing deliverables that support the clinical regulatory writing portfolio, and training junior writers. **Skills:** - Experience in authoring various clinical document types to support regulatory filings - Lead cross-functional teams to draft scientific/medical content - Understanding of the clinical development process - Effective communication and time management skills - People management experience - Customer focus and ability to work independently - Adherence to structured processes for document delivery - Ability to manage tasks, roles, and responsibilities within the authoring team - Strong knowledge of regulatory guidelines and regional requirements - Ability to interpret data and apply scientific knowledge to support regulatory document writing - Comfortable working on cross-functional teams **Knowledge Requirement:** - Strong scientific knowledge - Understanding of regulatory guidelines/requirements - Ability to interpret data and apply scientific knowledge - Manage messaging for consistency and alignment with strategy **Technology Skills:** - Expert authoring in MS Word - Experience working in document management systems - Capable of training writers/authors on the use of templates and tools **Responsibilities:** Prepare/review clinical study reports without guidance from senior members of the writing staff.,

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 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 defining, developing, and implementing metrics, standards, and tools to efficiently oversee the performance of the Pharmacovigilance and Medical Devices Vigilance system in terms of medical review of safety cases and management of safety signals. Key Responsibilities: - Conduct medical review of ICSRs, including assessment of Literature cases and authoring of enhanced MAC. - Support safety lead in authoring medical assessment letters based on the bi-annual/six-monthly line listing. - Perform literature review of assigned articles and assist in the review of articles for inclusion in PBRER, DSUR, IB, etc. - Provide support to Therapeutic Areas as per business needs, including co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents. - Assist in monitoring the safety profile of products, including activities such as literature review, medical review of individual cases, and medical evaluation of quality defects. - Co-author the PBRER and provide medical inputs to specific sections, including follow-up activities on HA assessment reports. - Contribute to the medical sections of DSUR, IB, labeling documents, Product Guidance Documents, and Expert Statements. - Support signal detection and evaluation activities for assigned products. - Assist in the preparation of Health Authority queries and other safety-related documents. - Act as a Subject Matter Expert for Medical Function processes and provide support during audits and inspections. - Collaborate with other Global Line Functions across Novartis and Third Parties to meet joint accountabilities. - Contribute to PV&PV initiatives and cross-functional projects to optimize medical review processes and quality. - Assist in the development and optimization of training materials and deliver training to Novartis staff and external stakeholders. Minimum Requirements: - Bachelor of Science in Pharmacy, Bachelor of Science in Nursing, PharmD, PhD in relevant field, or Medical Degree (MBBS or MD) required. - Minimum 3 years of experience in the pharmaceutical industry or related field. - Experience in safety document or medical writing, including proficiency in coding with MedDRA and WHO dictionaries. - Strong understanding of clinical trial methodology, ICH GCP, GVP guidelines, and medical terminology. - Attention to detail and quality focus. - Strong organizational and project management skills. - Excellent communication skills and ability to operate effectively in an international environment. - Good understanding of Human physiology, pharmacology, clinical study objectives, and the drug development process. - Technical understanding of Biomedical/Biostatistics concepts and strong problem-solving skills. - Good presentation skills. - Proficiency in computer skills, including creating spreadsheets, templates, presentations, and working with safety databases/applications. - Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability.,

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, you will coordinate quality and editorial reviews, manage source documentation, and act as a peer reviewer to ensure scientific content, clarity, consistency, and proper format of documents. In this role, you will interact with clients, department heads, and peers to produce high-quality writing deliverables. You will conduct online clinical literature searches, propose solutions to document issues, mentor less experienced medical writers, and maintain a strong working knowledge of drug development processes, regulatory guidelines, and industry best practices. The ideal candidate for this position should have a Bachelor's degree in a relevant discipline with at least 2 years of experience in science, technical, or medical writing. A graduate degree is preferred, and experience in the biopharmaceutical, device, or contract research organization industry is advantageous. Familiarity with FDA and ICH regulations, good publication practices, and the AMA Manual of Style is desired. In this dynamic role at Syneos Health, you will have the opportunity to contribute to the development of innovative therapies and make a meaningful impact on patient lives. If you are passionate about translating clinical insights into tangible outcomes and thrive in a collaborative and fast-paced environment, we invite you to join our team and be part of a global organization committed to customer success and employee well-being.,

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.,

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 manufacturers/scientists 5. Coordinate successful submissions and approval of all applications 6. Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil applicable regulatory and quality standards. 7. Plan, undertake and manage regulatory inspections 8. Keep up to date with national and international guidelines and customer practices 9. Develop and establish standard operating procedures that convey the best practices in the company 10. Collect, collate, and evaluate scientific data from a range of source. 11. Monitor and set timelines for licence variations and renewal approvals 12. Ensures that Good Clinical Practices (GCP) are followed. 13.Responding to any quality & regulatory issues related to clinical department and taking relevant corrective and preventive actions Secondary Responsibilities: 1. Ensure Quality Control review of protocols, ICF, CRF protocol amendments, Clinical Trial Reports, Investigator Brochures and regulatory submission documents. 2. Interpretation of data. 3. Preparation and Review of Clinical Study Report Interested candidates can share their resumes to keerthana.rojanala@vimta.com Contact: Keerthana