pstrongstrongCatalyst Clinical Research /strong /strong provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO,andmulti-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and general presence advance clinical studies. Visit CatalystCR.com.brAs 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.brstrongKey Essential Functionsbr/strongulliPrepares, 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. /liliParticipates in scientific communication planning, including development of strategic medical communication plans /liliManages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed /liliManages all aspects of outsourced or internal deliverable production and ensures project delivery /liliPartners 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 documents /liliSchedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion,



and post-meeting minutes /liliCollaborates 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 documents /liliEnsures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines /liliWorks closely with QA to maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables /liliEnsures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements /liliShowcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains. /liliConduct client/KOL interactions, kickoff meetings, and teleconferences as needed covering various time zones in an effective manner. /liliAct as project lead/delivery lead for assigned client and responsible for healthy partnership for each account. /liliSupport proactively in trainings department operation activities as needed.br/li /ulstrongRequired Skills Abilitiesbr/strongulliMust 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 writing /liliBroad experience managing the medical writing responsibilities associated with multiple studies at various stages and across various functional teams /liliAbility to work independently with minimal supervision, multi-task, and work effectively under pressure in a virtual RD organization; adapt to change as needed; possess excellent project management skills; attentive to details /liliAbility 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. /liliExcellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members /liliAbility to communicate scientific or medical information in a clear and concise manner /liliTrack record of increasing responsibility and independence in a similar role in pharmaceutical drug development /liliExcellent organization skills with acute attention to detail /liliStrong computer skills, including use of EndNote/ equivalent software within MS Word and other tools for MW activitiesbr/li /ulstrongRequired Qualificationsbr/strongulliBachelor’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. /liliProven 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. /li /ul /p #J-18808-Ljbffr

📌 Senior Medical Writer – Oncology & Regulatory Submissions (España)
🏢 Catalyst Clinical Research
📍 España