Overview
Scientific Writer Support Jobs in Cluj, Romania at Akkodis
Title: Scientific Writer Support
Company: Akkodis
Location: Cluj, Romania
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Role description:
The Scientific Writer Support is primarily responsible for the coordination of activities associated with clinical and nonclinical studies in close collaboration with Scientific Writers and Publishers. Responsibilities will range from Clinical Study Report (CSR) appendices coordination to preparation of clinical regulatory documents and technical quality check (QC) of scientific documents.
We expect the Scientific Writer Support to:
- Understand Good Clinical Practice (GCP), International Council for Harmonisation (ICH) Guidelines and local regulations as they apply
- Have basic knowledge of the drug development process as it relates to the execution of clinical trials with a focus on the document flow
- Manage multiple priorities and be able to accomplish tasks within a timeframe, setting milestones to meet deadlines and to achieve goals
- Perform tasks within expected timelines, with minimal errors.
Responsibilities
Support writing clinical documents
- Support the writing process of clinical documents (i.e., EU Application form (XML), Contact Script, Model Informed Consent Form (ICF))
Appendix coordination
- Track, collect and prepare clinical trial documentation related to the CSR appendices in accordance with ICH E6 principles
- Collaborate with the study team to develop study-related materials, cover pages, trackers
Technical QC (Quality control):
- Performs the technical QC of clinical documents (e.g., clinical study protocols and amendments, CSRs, Model ICF, etc) to ensure compliance with the submission standards
Administrative support of specific clinical documents
- File, track and maintain the Trial Master File (TMF) system
Establish timelines of activities
- Ensure availability of documents in client’s database system by proposed timelines
Qualifications
- Bachelor’s degree preferably in life sciences (Biology, Chemistry, Biochemistry, Pharmacy, Veterinary Medicine, etc.) (the bachelor’s degree in life science is NOT mandatory if the candidate has experience in the field, but it is a definite plus)
- Excellent command of English language (spoken and written) (Ability to write fluent and grammatically correct English is essential
- Work experience is mandatory in a similar coordination position, preferably previous clinical related job
- Knowledge in scientific areas is a plus
- Master’s degree in life sciences is a definite plus
Key knowledge areas
- Great written and oral communication skills
- Expertise in MS Office (Word, Excel, Power Point, Acrobat)
- Exceptional organizational skills and attention to detail
- Ability to effectively prioritize and execute tasks in a high-pressure, fast-paced environment is crucial
- Proactive attitude (willingness to identify and solve problems)
- Flexible and open to take on new challenges and responsibilities
- Knowledge of Food and Drug Administration (FDA) and or EU Regulations, ICH Guidelines, GCP, and/or familiarity with standard clinical operating procedures is a plus
Job offer
- Market competitive salary
- Food & holiday vouchers
- Private medical insurance
- Flexible work schedule
- Working from home
- Compensation for home working
