2 Eudract Jobs

Role & responsibilities Able to conduct literature searches (PubMed, EMBASE, clinicaltrial.gov, EudraCT, congresses, COCHRANE), screening, data extraction, and analysis to support content development. Independently compiles, writes, and edits medical writing deliverables including operating guidance documents, SOPs, training guides, etc. Develops research articles (primary/secondary), review articles, case reports, editorials, perspectives, short communications, abstracts, posters, oral presentations, visual abstracts, publication cards (static/interactive/video), publication summaries, and publication extenders. Works with team to produce high quality clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) as the lead writer. Guides team for requirements (keywords, analysis), creates structured data extraction forms, and able to lead systematic review. Prepares emailers/e-Blasts, microsite, flip books, booth materials such as flyers, bag inserts, roll-up banners (print/digital). Congress session coverage (daily highlights, training slides) and KOL interviews. Creates scientific slide decks, infographics, newsletters/news highlights. Supports ad boards, symposiums, webinars, standalone events with briefing slides and meeting materials. Develop podcasts, audio/video articles, animations, insights reports, and KOL profiling/mapping. Able to interpret the statistical data. Proof-reading and typesetting checks including correctness of font and symbols; text and image clarity/visibility; aesthetics (alignment, layout, consistency); formatting, spacing. Formatting documents based on journal/congress guidelines. Ensuring that the document adheres to specified style guides AMA/APA/Vancouver Manual of Style/brand style/Client Guidelines. Adheres to established regulatory standards as well as Company Standard Operating Procedures, client standards, brand guidelines, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Additionally, candidate will be expected to prepare the SOPs and training materials for the team. Preferred candidate profile Technical Skills : Adobe Suite, VEEVA PromoMats, EndNote, ZOTERO, Mendeley. Literature searches (NCBI, Cochrane, EMBASE, EudraCT, MEDLINE). Understands HTA (Health Technology Assessment) guidelines. Familiarity with EMA, FDA, NICE, and WHO evidence requirements. Systematic review tools (e.g., Covidence, Rayyan, DistillerSR). Systematic review methodologies. Soft Skills : Strong project management skills with the ability to handle multiple tasks under tight deadlines. Excellent communication skills to collaborate with cross-functional teams (medical affairs, marketing). Attention to detail with a strong focus on scientific accuracy and compliance. Languages : Excellent knowledge of the English language (spoken and written). Education - B.Sc./M.Sc./PhD/MD in life sciences/pharmacy or related field. Good to Have Publication planning & strategy. Statistical analysis knowledge. Basic understanding of graphic tools. Certification in medical writing, pharmaceutical communications, Gen AI is a plus. Demonstrated ability to work with tight timelines and a collaborative environment The ideal candidate is self-motivated and process-driven but able to deal with rapid change in a fast- paced, deadline-driven environment

Role Overview The Sr. Associate IS Engineer CTRS will support the Regulatory and Clinical Trial Submission (CTRS) product team by designing, developing, and maintaining software solutions to meet critical business needs. The role involves close collaboration with product managers, designers, engineers, and vendor partners, with a focus on applications like Disclose from Citeline and docuBridge Suite from Lorenz. The ideal candidate will bring hands-on technical expertise along with deep knowledge of regulatory submissions and clinical trial disclosure systems, playing a key role in maintaining application performance, compliance, and innovation. Roles & Responsibilities Design, develop, and maintain software applications aligned with clinical trial registration and regulatory submission needs Ensure system performance and availability for critical business applications such as Disclose and docuBridge Manage project scope, risks, and timelines to ensure successful software delivery Translate conceptual ideas into working code for rapid and effective development Apply SDLC principles to drive efficient software development processes Utilize ITIL and ITSM processes for reliable IT service delivery Work with business stakeholders to translate functional needs into data and technical requirements Provide technical guidance and mentoring to junior developers Collaborate with vendor partners on ETL pipelines (primarily Databricks/AWS) to support the disclosure platform Ensure complete and correct data flow from internal systems to Disclose Conduct User Acceptance Testing (UAT) and validate performance and data integrity Develop solutions using innovative technologies, including generative AI Maintain code quality through testing strategies including unit and integration tests Create and maintain technical documentation for architecture, deployment, disaster recovery, and operations Analyze functional and technical requirements and translate them into software architecture specifications Maintain ongoing application support and ensure smooth, continuous operations Implement system monitoring tools and dashboards to track health, availability, and performance Conduct root cause analysis and implement preventative measures Ensure the implementation of system security measures to protect against threats and unauthorized access Basic Qualifications Master's or Bachelor's degree with 5 to 9 years of relevant experience Must-Have Skills Deep understanding of pharma industry regulations and clinical trial disclosure requirements (FDA, EUCTR) Knowledge of submission publishing systems such as Lorenz docuBridge, ClinicalTrials.gov, EudraCT, and Veeva Vault Experience managing technology initiatives and mentoring development teams Ability to work in a fast-paced, dynamic environment with minimal supervision Experience applying methodologies like Scaled Agile Framework (SAFe) and ITIL Strong collaboration and communication skills Solid understanding of information systems, networking technologies, and compliance-driven environments Good-to-Have Skills Knowledge of eCTD specifications and GxP-regulated systems Experience in leadership roles within pharmaceutical or technology organizations Familiarity with software development lifecycle for GxP systems Hands-on experience with SAFe implementation and agile practices Strong critical-thinking and decision-making skills Knowledge of IS governance practices and cross-functional collaboration Broad exposure to IS domains including data, application, and infrastructure layers Professional Certifications ITIL (preferred) Scaled Agile Framework (SAFe) for Teams (preferred) Veeva Vault platform (preferred) Soft Skills Ability to work independently with minimal supervision Skilled in mentoring and team oversight Strong gap/fit analysis and analytical skills Excellent written and verbal communication Effective collaboration with global and virtual teams High initiative and self-motivation Strong multitasking and prioritization skills Team-oriented mindset with a focus on shared goals Confident presenter with public speaking skills