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Posted 21 days ago

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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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