||Clinical Development - Oncology
||Chief Medical Officer
||Prague, Czech Republic
||Full Time Employment
Key Activities and Responsibilities
The purpose of this position is to research, create and revise various documents associated with clinical research. The documents may be submitted to Health Authorities worldwide to support clinical development and registration of drug candidates as well as to communicate study data both internally and externally, including publication in peer-reviewed scientific journals.
- Medical writing activities that support the preparation of regulatory & clinical documents required to support global drug development and registration activities.
- Serve as the primary medical writing representative on assigned product teams and closely collaborate with personnel from clinical, regulatory and scientific departments.
- Manage the quality, accuracy, compliance with internal & external standards and the timely production of English-language documents using electronic document management system.
- Manage the writing, editing and reviewing of diverse regulatory & clinical documents including clinical study reports (CSRs), study protocols, investigator brochures, informed consent forms, clinical data summaries and other medical/regulatory documents (including regulatory summary documents).
- Develop, implement and manage templates & documentation format required for standardization of regulatory & clinical documentation to support development and registration activities.
- Participate in the development of scientific manuscripts and abstracts reporting clinical study data, as well as slide & poster presentations.
- Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to guidelines/SOPs including: distribute drafts, chair review meetings, incorporate revisions, document key project events and complete sign-off procedures.
- Create/maintain audit system/trails of all document changes.
- Perform literature searches/reviews as necessary to obtain background information for development of documents.
Competences, Skills and Qualification
The successful candidate should be self-motivated, flexible, creative, able to prioritize, multi-task and work in a fast-paced & demanding environment. He/she must think independently, solve problems proactively and function well as a collaborative team member.
- Ability to understand and interpret data/information and its practical application
- Excellent English written/oral communication skills
- Excellent scientific writing and ability to adapt style & content for different target audiences
- Excellent technical editing and QC skills
- Accurate and detail-oriented, with excellent inter-personal skills
- Strong time and project management skills
- Demonstrated ability to lead others to complete projects
- Strong understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, project management and medical terminology
- Experience advancing numerous projects simultaneously
- Experience working in a matrix team environment
- Computer skills
- Ability to search and scan various internal & external databases
- Doctorate degree & 2 years of directly related experience –or– Master's degree & 4-6 years of directly related experience –or– Bachelor's degree & 6-8 years of directly related experience ‐ Degree(s) should be in Life Sciences/Health Related Sciences from an accredited college or university
- 2-3 years of medical writing experience in a biotech or pharmaceutical company, preferably in the oncology therapeutic area
- Knowledge of global regulatory publication guidelines (FDA, EMA, ICH, etc.) and best practices
- Proficient in pertinent software (eg, MS Office, EndNote, Adobe Illustrator)
- Must be knowledgeable in industry trends for study reports and international dossier preparation (eg, IND/CTA/NDA/BLA/MAA),
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