Regulatory Medical Writing
2 weeks ago
the RoleSenior Medical Writer is responsible for the development and review of medical writing deliverables that support the clinical regulatory writing portfolio and train the junior writers.
ResponsibilitiesWithout guidance from senior members of the writing staff, prepare/review clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical developmentApply lean authoring principles as part of document development and, when applicable, structured content management text libraries as part of authoring processCoordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelinesDevelop and maintain project plansWork as an active member of cross-functional teams representing Medical WritingCoordinate and deliver document kick-off meetings with writers and cross-functional representativesEnsure adherence to standard content, lean authoring, and messaging across team membersEnsure communication between members remain open and information is disseminated appropriatelyPossible participation in the orientation and coaching of junior team membersConduct appropriate literature searches and screening, as neededParticipate on Medical Writing department initiatives, as appropriateResearch regulatory requirements to remain current in the regulatory landscapeShare lessons learned and best practicesEnsure compliance with company training and time reporting
QualificationsMBBS/PhD/MDS/BDS/MPharm/PharmD4 to 8 years’ experience in writing Clinical & Regulatory documents for global filings (CTD Module 2 , 4 and Module 5)
Required SkillsExperience 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, 2.7, 5.2, clinical study reports (CSRs,) protocols, amendments, and Investigator Brochures (IBs)Demonstrated excellence in focused/lean writing and editing following defined processes and templatesLead cross-functional teams to draft agreed-upon scientific/ medical content that addresses data interpretation, product claims, and internal/external questionsUnderstanding of clinical development process from program panning to submission, including clinical trial designCommunication skills commensurate with a professional working environmentEffective time management, organizational, and interpersonal skillsCustomer focusComfortable following directions, templates, and structured processes for delivering documents for review and finalizationAble to work independently while maintaining communication with the Sponsor’s MW project managerAbility to move across Therapeutic Areas to support business continuity and resource needsAbility 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 timelinesDevelop work plan and ensure adherenceAbility to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completionAdherence to processes and Sponsor-defined best practicesAbility to facilitate review meetings, address feedback, and negotiate solutions/agreements
Preferred SkillsStrong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United StatesAbility 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 scienceUnderstanding of medical practices regarding procedures, medications, and treatment for different disease statesManage messaging for consistency with historical information and in alignment with agreed-upon strategyCapable of providing insight, alternatives, and suggestions based on previous experiencesComfortable working on cross-functional teams with the ability to drive document content to support lean authoringExperience writing protocols, amendments, CSR, and CTD summary documentsExpert authoring in MS Word, understanding of MS Word functionalityExperience working in document management systems; managing workflows eApproval/signaturesExperience working with Word add-ins that facilitate the management of fonts, styles, references, etc.Flexibility in adapting to new tools and technologyCapable of training writers/authors on the use of templates, guidelines, and tools
Equal Opportunity StatementIndegene 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.
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