3 Module 2 Jobs

Role & responsibilities Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, and regulatory standards in response. Evaluation and good interpretation of post approval changes. Submission of supplements like CBE, CBE-30 and Prior Approval Supplement (PAS).Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines. Evaluate and interpret post-approval changes & Review of Pharmaceutical Development Reports, Review key regulatory documents such as specifications, process validation reports, hold time reports, stability protocols/data, Nitrosamine risk assessment reports, and technical packages. Formulate US regulatory filing strategy for new projects. Preparing quarterly and monthly targets. Allotting and evaluating targets of the team. Good interpretation skill for ICH and FDA guidelines

Job Title: Senior Medical Writer Regulatory Writing Education Requirements: MBBS / PhD / MDS / BDS / MPharm / PharmD/M.Sc/B.Pharma/B.Tech Location: Bangalore (Hybrid as applicable) Experience: 8 to12 years of experience in authoring clinical and regulatory documents supporting global filings, particularly CTD Module 2 and Module 5. Role Purpose: This role involves managing complex medical writing projects, reviewing regulatory deliverables, and mentoring junior writers. The position requires both strategic thinking and hands-on execution in support of global regulatory submissions. Key Responsibilities: Independently prepare and review regulatory documents such as clinical study reports (CSRs), protocols, investigator brochures (IBs), informed consent forms (ICFs), and CTD Modules (2.4, 2.5, 2.6, 2.7, 5.2). Apply lean authoring and structured content principles to regulatory documents. Coordinate cross-functional review meetings and finalize documents under tight timelines. Develop and maintain detailed project plans and task trackers. Drive consistency in content and messaging across document sets. Lead and facilitate document kick-off and consensus meetings. Mentor and manage junior writers; provide guidance on templates, standards, and expectations. Perform literature reviews, competitive intelligence, and regulatory research as needed. Actively contribute to departmental initiatives, process improvements, and knowledge sharing. Ensure full compliance with training, documentation, and submission standards. Required Skills & Competencies: Proven experience in authoring a broad range of clinical and regulatory documents for global filings. Strong grasp of regulatory expectations across US, EU, and other major markets. Ability to interpret data, build scientific arguments, and align with regulatory strategy. Expertise in managing cross-functional teams and stakeholder communications. Excellent time management, organizational, and interpersonal skills. Strong written communication and technical editing abilities. Minimum 2+ years of people management or mentoring experience. Strong customer focus and collaborative mindset. Ability to support multiple therapeutic areas and ensure business continuity. Technology Proficiency: Advanced MS Word skills (styles, templates, reference tools). Experience with document management systems and electronic review workflows. Familiarity with structured content authoring tools and add-ins. Adaptability to new tools, platforms, and digital collaboration environments. Scientific & Regulatory Knowledge: Deep understanding of the clinical development lifecycle from study design to submission. Ability to develop regulatory content based on scientific logic, data interpretation, and therapeutic knowledge—even in the absence of direct data. Up-to-date knowledge of global regulatory guidelines (e.g., ICH, FDA, EMA). Skilled in aligning messaging with clinical strategy and prior submissions. Capable of simplifying complex scientific data for regulatory communication.

Role & responsibilities We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent thats bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com If this excites you, then apply below. Associate Manager – Regulatory Writing (Clinical) EXPERIENCE: 10 to 12 years’ experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5) ROLE PURPOSE: This role is responsible for handling complex Medical Writing projects and provide review support for medical writing deliverables that support the clinical regulatory writing portfolio along with training the junior writers. SKILLS: • Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports (CSRs,) protocols, amendments, ICFs & amendments, and Investigator Brochures (IBs) • Demonstrated excellence in focused/lean writing and editing following defined processes and templates • Lead cross-functional teams to draft agreed-upon scientific/ medical content that addresses data interpretation, product claims, and internal/external questions • Understanding of clinical development process from program panning to submission, including clinical trial design • Communication skills commensurate with a professional working environment • Effective time management, organizational, and interpersonal skills • People management experience for more than 2 years • Customer focus • Comfortable following directions, templates, and structured processes for delivering documents for review and finalization • Able to work independently while maintaining communication with the Sponsor’s MW project manager • Ability to move across Therapeutic Areas to support business continuity and resource needs • Ability to develop, coordinate, and oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines • Develop work plan and ensure adherence • Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion • Adherence to processes and Sponsor-defined best practices • Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements KNOWLEDGE REQUIREMENT: Scientific Knowledge • Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States • Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, Clinical summaries) • Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science • Understanding of medical practices regarding procedures, medications, and treatment for different disease states • Manage messaging for consistency with historical information and in alignment with agreed-upon strategy • Capable of providing insight, alternatives, and suggestions based on previous experiences • Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring • Experience writing protocols, amendments, CSR, and CTD summary documents Technology Skills • Expert authoring in MS Word, understanding of MS Word functionality • Experience working in document management systems; managing workflows eApproval/signatures • Experience working with Word add-ins that facilitate the management of fonts, styles, references, etc. • Flexibility in adapting to new tools and technology • Capable of training writers/authors on the use of templates, guidelines, and tools RESPONSIBILITIES: • Without guidance from senior members of the writing staff, prepare/review clinical study reports, protocols, investigator brochures, submission documents (Module 2 summaries), and other regulatory documents on investigational drugs in various stages of clinical development • Apply lean authoring principles as part of document development and, when applicable, structured content management text libraries as part of authoring process • Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines • Develop and maintain project plans & work plan for the team members • People management • Work as an active member of cross-functional teams representing Medical Writing • Coordinate and deliver document kick-off meetings with writers and cross-functional representatives • Ensure adherence to standard content, lean authoring, and messaging across team members • Ensure communication between members remain open and information is disseminated appropriately • Possible participation in the orientation and coaching of junior team members • Conduct appropriate literature searches and screening, as needed • Participate on Medical Writing department initiatives, as appropriate. • Research regulatory requirements to remain current in the regulatory landscape • Share lessons learned and best practices • Ensure compliance with company training and time reporting EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.