Senior Medical Writer
- Full-time
- Department: Medical Writing
Company Description
Founded in 1997 by a Medical Doctor , Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials. Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for complex trials in Rare Diseases, Oncology and Neuroscience.
Job Description
- Undertakes allocated medical writing projects, to include, but not limited to, clinical study report, protocol, master patient information and consent form.
- Ensures that all documents are written to a high standard, follow all applicable regulations and are delivered within timelines
- Evaluates, summarises and interprets data, with assistance from Ergomed colleagues where applicable
- Performs QC checks of medical writing deliverables from other MWs
- Provides medical writing training to more junior colleagues as requested
- Ensures the medical writing tracker is updated in a timely manner, to track the various document drafts through the drafting process, for co-ordinating reviews and QC activities and for ensuring agreed timelines are complied with
- Attends and reports on project status at weekly MW calls and update MW department tracker for projects in progress or upcoming
- Provides feedback and assistance to develop, review and edit Medical Writing SOPs and Templates to assure consistency with “Good Practices” and other regulatory standards/requirements
- Is a point of contact for Ergomed Data Management, Regulatory, and Clinical Development. Manages and co-ordinates the interaction between these parties, any in-sourced experts, and the Sponsor for allocated project
- Provides input to Business Development Request For Proposals if required
- Provides back up to Head of Medical Writing when required.
- Attends conferences, external training, WebEx and online training relevant to job role
Qualifications
5 years experience of medical writing clinical study reports, protocols, consent forms and other regulatory documents
Able to mentor junior medical writers, providing leadership and guidance
Able to deputise for the Head of Medical writing when needed.
Strong communications skills and able to attend Bid defence meetings if required.
Additional Information
We offer excellent chances to progress and develop. We work on a global basis on interesting projects within rare diseases, oncology, and neurology.
Intially this will be a home based role, but this could be either home or office based in the Princeton area from Q1 of 2020