Lifelancer is hiring: Principal Medical Writer in Wilmington

About the job Principal Medical Writer Job Title: Principal Medical Writer Job Location: United States Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.comAs a Principal Medical Writer, you will collaborate with members of cross-functional teams to prepare (or oversee preparation by contract service providers) high-quality protocols, protocol amendments, investigator brochures, synopses, Clinical Study Reports, regulatory documents such as INDs and BLAs, clinical publications, and related clinical documents within agreed-upon timelines.Key Essential FunctionsPrepares, edits, and finalizes protocols, investigator brochures, synopses, Clinical Study Reports, pre-IND, IND, NDA submissions, other regulatory documents and related scientific documents, such as abstracts, posters, presentations, and manuscripts, integrating inputs from other team members into a cogent fit-for-purpose whole.Participates in scientific communication planning, including development of strategic medical communication plansManages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressedManages all aspects of outsourced or internal deliverable production and ensures project deliveryPartners with other clinical team members including participation in the review of mock and/or blinded tables, figures, and listings (TLFs), and narrative planning for relevant documentsSchedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutesCollaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documentsEnsures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelinesWorks closely with QA to maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverablesEnsures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvementsShowcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains.Conduct client/KOL interactions, kickoff meetings, and teleconferences as needed covering various time zones in an effective manner.Act as project lead/delivery lead for assigned client and responsible for healthy partnership for each account.Support proactively in trainings & department operation activities as needed.Required Skills & Abilities:Must have a thorough knowledge of clinical research concepts, practices, and FDA/EMA/other regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writingBroad experience managing the medical writing responsibilities associated with multiple studies at various stages and across various functional teamsAbility to work independently with minimal supervision, multi-task, and work effectively under pressure in a virtual R&D organization; adapt to change as needed; possess excellent project management skills; attentive to detailsAbility to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team membersAbility to communicate scientific or medical information in a clear and concise mannerTrack record of increasing responsibility and independence in a similar role in pharmaceutical drug developmentExcellent organization skills with acute attention to detailStrong computer skills, including use of EndNote/ equivalent software within MS Word and other tools for MW activitiesRequired QualificationsBachelor's degree +12 years, Master's Degree +7 years, Doctoral Degree +5 years of relevant medical writing experience in the pharmaceutical industry, especially writing in oncology; graduate degree (masters or doctoral) preferred.Proven successful experience with writing INDs, Clinical protocols, Clinical study reports, Investigator Brochures, regulatory correspondence and documents, and/or NDAs/BLAs, and peer-reviewed journal articles. Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.https://lifelancer.com/jobs/view/0373de92a112127c57a1e2134f782f9f