W skrócie
- Zadania: Twórz i zarządzaj dokumentami klinicznymi oraz regulacyjnymi w dynamicznym środowisku.
- Firma: Parexel - globalny lider w rozwoju klinicznym z zespołem 22,000+ pracowników.
- Benefity: Możliwość pracy zdalnej, rozwój zawodowy i praca nad innowacyjnymi projektami.
- Pozostałe informacje: Szybkie tempo pracy z możliwościami rozwoju kariery w branży zdrowia.
- Dlaczego ta praca: Przyczyń się do postępu w badaniach klinicznych i pomocy pacjentom na całym świecie.
- Kwalifikacje: Doświadczenie w pisaniu medycznym i umiejętności zarządzania projektami.
Przewidywane wynagrodzenie mieści się w przedziale 67500 - 82500 zł za rok.
About Parexel
Parexel is a leading global clinical development partner delivering insights driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.
About the Role
We are seeking a Medical Writer II to join our team in Poland, Spain, Romania, or Serbia. As a Senior Medical Writer, you will serve as a dedicated, embedded resource supporting the development of high quality clinical and regulatory documents. This role plays an important part in advancing clinical research by ensuring the timely preparation, coordination, review, and finalization of key clinical documents, including Clinical Trial Reports (CTRs), Clinical Trial Protocols (CTPs), protocol amendments, Investigator's Brochures (IBs), biomarker reports, and submission related documentation.
Key Responsibilities
- Develop and maintain clinical and regulatory documents including CTRs, CTPs, protocol amendments, IBs, biomarker reports, and submission documents.
- Manage clinical documents within the Electronic Document Management System (EDMS), including document setup, workflow management, and approvals.
- Establish, communicate, and maintain agreed project timelines in collaboration with trial and project teams.
- Prepare for, facilitate, and document project meetings, kick off meetings, Results Alignment Meetings, trial team meetings, and submission meetings as required.
- Draft clinical documents, including appropriate in text tables and figures, in accordance with agreed timelines and applicable procedures.
- Coordinate and manage document review cycles, drive alignment on comments, integrate revisions, and complete required review documentation.
- Initiate, conduct, or oversee quality control activities and complete supporting quality control documentation.
- Finalize and deliver completed documents to project teams and support document publishing and pre archive activities.
- Perform technical and formatting checks for Investigator's Brochures and related updates.
- Support final electronic approval processes and ensure compliance with established procedures, systems, and standard operating procedures.
- Collaborate effectively within an integrated team environment and participate in ongoing project governance, feedback, and alignment activities.
Candidate Profile
You'll thrive in this role if you bring:
- Strong medical writing, project coordination, and document management capabilities.
- Experience working in clinical research or another regulated environment.
- The ability to collaborate across teams and communicate clearly with a variety of stakeholders.
- A quality focused mindset and strong attention to detail.
- Comfort working with electronic document management systems, document review processes, and quality control procedures.
Required Qualifications
- At least 1 year experience as Medical Writer.
- Bachelor's degree or equivalent combination of education and relevant experience.
- Knowledge of clinical development documentation processes and regulated working environments.
- Experience working with Electronic Document Management Systems (EDMS) and document lifecycle management processes.
- Strong communication, organization, stakeholder management, and problem solving skills.
Preferred Qualifications
- Advanced scientific, life sciences, or related educational background.
- Experience supporting clinical trial documentation and regulatory submissions.
- Familiarity with clinical document review, quality control, publishing, and approval workflows.
- Experience collaborating within cross functional clinical development teams.
Medical Writer II in Warsaw – pracodawca: Parexel
Parexel FSP to doskonały pracodawca, oferujący stabilne zatrudnienie oraz liczne możliwości rozwoju kariery w dynamicznym środowisku. Praca w Warszawie jako Clinical Study Administrator w zespole pełnym doświadczonych profesjonalistów zapewnia nie tylko atrakcyjne wynagrodzenie i bogaty pakiet benefitów, ale także kulturę współpracy i innowacyjności, co czyni tę rolę wyjątkową szansą na rozwój w branży badań klinicznych.
