Senior Medical Writer

at

Ergomed

Cary, NC
Full Time
1y ago

Company Description

PrimeVigilance, an Ergomed brand, was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects.

Ergomed Plc is a public company on the London stock exchange with its HQ in Guildford, UK.  The company boasted 40% growth in its revenues in its last report.

This success is due to the hard work of our highly skilled employees and our subsequent reputation for excellence with our clients. 

 

 

Job Description

The PrimeVigilance medical writer position offers a unique opportunity to further develop your career in the field of drug safety.

Key Responsibilities

  • Independent authoring, editing and reviewing of various regulatory/clinical documents (e.g. aggregate reports, risk management plans and other documents needed throughout the product’s life cycle) with the responsibility for the quality and content of the document and compliance with internal and external standards
  • Active participation in trainings and development, implementation and maintenance of quality system documents for medical writing, including internal templates and formats required for standardised documentation
  • Support in all pharmacovigilance operations associated with medical writing
  • Continuous self-education in all aspects associated with medical writing

Qualifications

  • Previous experience of pharmacovigilance medical writing, including PBRERs, DSURs, RMPs writing
  • MD or PhD in field of biomedicine and healthcare or natural sciencies
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail
  • Ability to effectively train and mentor Associate Medical Writers
  • Advanced knowledge of English

Additional Information

All your information will be kept confidential according to EEO guidelines.

Our Offer:

  • Work within a successful, highly – qualified and dynamic team
  • Professional training and career development in a fast-growing healthcare company
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