ph3About the Company /h3 pstrongCatalyst Clinical Research /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 versátil service model, innovative technology, expert team members, and global presence advance clinical studies. /p h3Position Overview /h3 pAs 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. /p h3Key Essential Functions /h3 ul liPrepares, 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. /li liParticipates in scientific communication planning, including development of strategic medical communication plans. /li liManages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed. /li liManages all aspects of outsourced or internal deliverable production and ensures project delivery. /li liPartners 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. /li liSchedules and conducts document‑related meetings including the preparation of pre‑meeting agenda, key data points for discussion, and post‑meeting minutes. /li liCollaborates 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. /li liEnsures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines. /li liWorks closely with QA to maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables. /li liEnsures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements. /li liShowcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains. /li liConduct client/KOL interactions, kickoff meetings, and teleconferences as needed covering various time zones in an effective manner. /li liAct as project lead/delivery lead for assigned client and responsible for healthy partnership for each account. /li liSupport proactively in trainings department operation activities as needed. /li /ul h3Required Skills Abilities /h3 ul liMust 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.



/li liBroad experience managing the medical writing responsibilities associated with multiple studies at various stages and across various functional teams. /li liAbility 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. /li liAbility 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; elevate complex issues appropriately. /li liExcellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members. /li liAbility to communicate scientific or medical information in a clear and concise manner. /li liTrack record of increasing responsibility and independence in a similar role in pharmaceutical drug development. /li liExcellent organization skills with acute attention to detail. /li liStrong computer skills, including use of EndNote/ equivalent software within MS Word and other tools for MW activities. /li /ul h3Required Qualifications /h3 ul liBachelor’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. /li liProven 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 h3Seniority Level /h3 pMid‑Senior level /p h3Employment Type /h3 pFull‑time /p h3Job Function /h3 pMarketing, Public Relations, and Writing/Editing /p h3Industries /h3 pResearch Services /p /p #J-18808-Ljbffr

📌 Principal Medical Writer (España)
🏢 Catalyst Clinical Research
📍 España