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Medical Writer - Team Lead

Ref: 9217841

  • €45,000 - €50,000
  • 17 Jun 2019
  • Dublin (West)
  • Perm

Brightwater is delighted to be retained in the search for a Medical Writer – Team Lead to act as a central point of contact for safety variations, including liaising with APTL RA to plan and co-ordinate safety variation submissions. Investigating any non-compliance with safety variation submission deadlines and lead the ongoing development of the processes needed to ensure that safety variation regulatory requirements are met.

Financial:

• Project management of contractual and financial aspects of all medical writing projects and the effective utilisation of resources to keep processes cost effective • Identification of project challenges to departmental line management and the financial impact

Project Management:

• Act in the capacity of project manager/lead for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues • Project management of contractual and financial aspects to be performed with management where necessary • Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to Group guidelines/SOPs • Coordinate production and distribution of draft and final documents to regulatory teams. Ensure that all work is complete and of high quality prior to team distribution • Assist management as needed with preparation of resourcing estimates for potential new medical writing projects • Proactively engage with other departmental resources where necessary to ensure that information/documentation requests are delivered in a professional and timely manner

Medical Writing Accountabilities:

• Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review • Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate SOPs and style guidelines • Perform literature searches/reviews as necessary to obtain background information and training for development of documents • Assist in the assessment of clinical and nonclinical documentation with regards to its suitability for supporting new marketing authorisation applications (MAA) or new indications

Safety:

• Planning and co-ordination or safety variation submissions including but not limited to the roll out our CCDS updates, Regulatory Agency recommendations • Investigation of non-compliance with safety variation submission deadlines and development of process improvements to avoid any future non-compliance • Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports • Preparation of Risk Management Systems including but not limited to Risk Management Plans, Dear Healthcare Professional Letters and Risk Communication Plans • Manage safety related requests from regulatory agencies and Affiliates to ensure any requests are answered fully and promptly To apply for this Medical Writer – Team Lead role, click the “Apply Now” button or for more information, please contact Marc Bentley on 01 662 1000 or email m.bentley@brightwater.ie