Summary of position
Director of MW is one of the key positions within ERGOMED and is responsible for providing medical writing expertise and leadership to deliver the high quality and efficiency of the Medical Writing Department to ERGOMED clinical operations - reports to Head of Clinical Operations.
Duties and responsibilities of Head of Medical Writing are:
- Ensures that procedures required for medical writing activities are defined and reflect current processes and applicable regulatory requirements
- Write, review and / or approve medical writing SOPs
- Reviews and updates all document templates to be compliant with all applicable regulatory requirements
- Ensures all MW projects come in within timelines and budgeted hours
- Ensures all projects follow ERGOMED processes
- Ensures that all medical writing resources are qualified for task(s) allocated and trained to the required Ergomed SOPs and industry guidance documents ahead of performing respective task
- Performs training of medical writing staff, and operational staff as required
- Identifies the medical writing document requirements (e.g. protocol, ICF, CSR), and oversees any related “Third Party Quality Assessment“ in conjunction with QA.
- Contracts with external medical writing resource if applicable (including the issuing of CDAs and MSAs / Clinical Trial Orders – the latter in conjunction with the study PM) and fee negotiation.
- Is the point of contact for ERGOMED Data Management, Regulatory, Statistics and Clinical Development; Manages and co-ordinates the interaction between these parties, and Sponsors of all studies.
- Estimates the budget for a given proposal requesting MW services.
- Assesses externally contracted medical writers taking into consideration any QC findings and / or client feedback, as part of ongoing third party oversight and management.
- Ensures ongoing training and supervision of in house MW resources
- Is the main point of contact for the escalation of any quality or performance issues raised by either the Writers or Reviewers
- Provide input to Business Development Request For Proposals as requested
- Represents Ergomed at Sponsor meetings and attend teleconferences as requested
Degree educated or equivalent.
Demonstrated experience as a Medical Writer in ideally a CRO environment including clinical study reports, protocols, master patient information and consent forms
- Srbija, Beograd, Đorđa Stanojevića 14
- PIB: 109436311
- Matični broj: 21181986