Senior Medical Writer

Job Description Synterex, Inc. is aglobalconsortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support.Synterexoffers remote or on-site services, with a focus on providing clear, concise,accurate, and fully compliant documentation, from early drug development through post-approval. Synterexisseekingan organized, motivated, and collaborative individual for our medical writing team.Theseniormedical writer will partner cross-functionallywith client teams inClinical Development, Clinical Operations,Biostatistics,Regulatory, and Program Management inleading theplanning and preparation of high-quality clinical regulatory documents. The medical writer may produceprotocols, publications, study reports, investigator brochures,narratives,and module documents, according to clientand agency guidelines,to support drug development underbrisktimelines. Location: Fully remote, but must be able to attend key (e.g., roundtable or kickoff) meetings on site with clients asrequested. Essential Duties & Responsibilities Lead theexecution of documents, includingproject management tasks such ascreating,maintaining, and communicatingtimelines Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing)to ensuretimelycompletion ofdocuments Ensuredocument developmentadherestoanyrelevantclient processes, templates, and instructionaldocuments Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient documentdevelopment Lead document message development in collaboration withclient Interpret data and create shell documents to supportauthoring Plan and lead kickoffmeetings Facilitate resolution of review feedback including planningand leadingcomment resolution meetings(curate review comments to ensuremeetings areefficient) Follow-up with individual team members asneeded to resolve outstanding reviewfeedback Ensure consistency among client programs in terms of messaging, formatting, and presentation ofdocuments Conduct literature searches asneeded Perform peer QC review asneeded Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management), if needed Requirements Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field Bachelor’s degreeor higherin a relevant field Oncology, InfectiousDisease, or Vaccineexperiencedesired Experiencedesiredin writingclinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5documents Flexibility towork across multiple therapeutic areas, if needed Experiencewriting documents according toestablished processes and documenttemplates Familiarity with lean authoring approachesand structured content management Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements isdesired Expertisewith Microsoft Word and other Microsoft applications Experiencedeveloping documentsusingdocument management systems, collaborative authoringtools, and reviewtools Comfortableadaptingto newtools andtechnologies, if needed Ability to work both independently and collaboratively in the face of competingpriorities Service-oriented and proactive approach to projectmanagement Excellent conflict management and negotiation skills Comfortable providing suggestions based onpreviousexperience Strong written and verbal communication skills Synterexprovides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal,stateor local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence,compensationand training. Synterexparticipates in the Department of Defense’sSkillBridgeprogram. For more information, please visit #J-18808-Ljbffr Synterex Inc