Job Details

Parexel is looking for a Senior Medical Writer located anywhere in the United States or Canada .Early Development/Translational Medical Writing experience required.Job Purpose:The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals.Key Accountabilities:LeadershipLeads cross-functional teams to draft agreed-upon scientific/medical content that addresses data interpretation, product claims, and internal/external questionsCoordinates and delivers document kick-off meetings with contributors or representatives from cross-functional groupsCoordinates activities for document review, consensus meeting, quality control, and document finalization under aggressive timelinesEnsures communication between members remains open and information is disseminated appropriatelyPossible participation in the orientation and coaching of junior team membersRegulatory Document AuthoringDevelops, coordinates, and oversees 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 timelinesDevelops and maintains timelines in project plans, using project tracking application following standard templatesWith minimal guidance from senior members of writing staff, prepares clinical study reports (CSRs), protocols, investigator brochures (IBs), submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical developmentManages messaging for consistency with historical information and in alignment with agreed-upon strategyApplies lean authoring principles as part of document development and, when applicable, structured content management (SCM) text libraries as part of authoring processEnsures adherence to standard content, lean authoring, and messaging across team membersWorks as an active member of cross-functional teams representing Medical WritingConducts appropriate literature searches, as neededCompliance with Parexel StandardsComplies with required training curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirementsSkills:Focused writing and editing following defined processes and templatesExpert level authoring in MS Word, understanding of MS Word functionality, and works with Word add‑ins that facilitate the management of fonts, styles, references, etcFollows directions, templates, and structured processes for delivering documents for review and finalizationParticipates in Medical Writing department initiatives, as appropriateResearches regulatory requirements to remain current in the regulatory landscapeShares lessons learned and best practicesAbility to work independentlyAbility to move across therapeutic areas to support business continuity and resource needsAbility to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completionCustomer focused with communication skills commensurate with a professional working environment as well as effective time management, organizational, and interpersonal skillsFluent in reading and writing American EnglishKnowledge and Experience:Minimum 5 years in writing regulatory documents supporting global filingsOncology and/or Infectious Disease/Vaccines experienceStrong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the EU and USRegulatory filing experience with a focus in authoring a broad set of different clinical document types that support regulatory filings such as protocols, amendments, CSRs, and common technical document summary documents with a preference for experience with Module 2.7, 5.2, CSRs, protocols, amendments, and IBsUnderstanding of clinical development process from program planning to submission, including clinical trial design as well as medical practices regarding procedures, medications, and treatment for different disease statesAbility to facilitate review meetings, address feedback, and negotiate solutions/agreementsAbility to interpret data and apply scientific knowledge to support regulatory document writing (i.e., IBs, protocols, amendments, CSRs, clinical summaries) as well as build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area scienceAbility to develop and use story boards to drive statistical output planning, link data results to key messages, and develop templates as starting points for authoringExperience working on cross-functional teams with the ability to drive document content to support lean authoringExperience working in collaborative authoring tools and review tools, project tracking applications and document management systems; managing workflows eApproval/esignatures; and familiar with SCM and ability to author in an SCM environment using text librariesFlexibility in adapting to new tools and technology with capability of providing insight, alternatives, and suggestions based on previous experiencesCapable of training writers/authors on the use of templates, guidelines, and toolsEducation:Bachelor's degree or equivalent (Life Science preferred)EEO Disclaimer:Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.#J-18808-Ljbffr