Medical Writing Officer
AthensOn-siteFull-time
AI Summary
Prepares clinical and non-clinical scientific documents for pharmaceutical and medical device products, provides technical expertise to Regulatory Affairs and Business Development, and acts as a Clinical/Non-Clinical Expert on Marketing Authorization renewals and variations.
About this role
In this dynamic and fast growing environment we are looking for a high caliber Medical Writing Officer who will be responsible for writing and providing advisory information on curative categories and products.
Medical Writing Officer
Main duties and responsibilities:
- Prepares clinical and non-clinical scientific documents for pharmaceutical and medical device products.
- Provides technical and scientific expertise to the Regulatory Affairs and Business Development departments to support specific business needs.
- Prepares Risk Management Plans (RMPs) and Risk Minimization Materials (RMMs).
- Maintains and archives records related to departmental activities.
- Prepares and updates Standard Operating Procedures (SOPs), in the absence of the Senior Medical Writing Officer.
- Communicates with partner companies in Greece and abroad on medical and scientific matters.
- Acts as a Clinical / Non-Clinical Expert on matters related to Marketing Authorization renewals and variations to product information.
- Reviews clinical trial protocols and clinical study reports.
Requirements
- BSc Degree in Life Sciences, Clinical Pharmacy, Clinical Pharmacology or Medicine. MSc or PhD Degree in relevant field will be considered an asset.
- At least 3 years experience in a relevant field, preferably in Pharmaceutical industry or Contract Research Organization (CRO).
- Computer literacy.
- Fluent in Greek & English.
- Excellent communication skills.
- Analytical and critical thinking, problem solving ability.
- Self-motivated & results oriented with ability to cope with strict timelines.
Benefits
The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.
Skills
Clinical Document PreparationClinical Study ReportsClinical Trial ProtocolsComputer LiteracyMarketing Authorization RenewalsProduct Information VariationsRegulatory AffairsRisk Management Plans (RMPs)Risk Minimization Materials (RMMs)Standard Operating Procedures (SOPs)
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