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Medical Writer Team Lead

Employer
Thornshaw Recruitment
Location
Dublin (County), Leinster (IE)
Salary
Negotiable
Start date
15 Aug 2019
Closing date
14 Sep 2019

Job Details

An exciting new Medical Writer Team Leader role now exists in a global pharmaceutical company. 
Act as a central point of contact for safety variations, including liaising with 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.
Establish a central point of contact for all medical writing projects, liaising with other Group departments as the need arises. 
Undertake all research, creation, and editing of all documents to comply with safety and clinical updates according to the Global Company Core Datasheet (CCDS) for all Products.  
Develop a framework for setting internal and external deliverables against each medical writing project, to include project goals and objectives and measurement criteria and business outcomes for each project goal. Conduct leadership, training and support of junior medical writing staff.

Duties
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 thereof. 
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
•    Serve as the Medical Writing representative to provide proactive support for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables.  Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options
•    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
•    Attend internal and technical team meetings as required
•    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 timeous manner  
Medical Writing Accountabilities:
•    Write clinical documents for submission to regulatory authorities, including but not limited to:  
o    clinical overviews and summaries 
o    clinical expert statements
o    interim and final clinical study reports
o    integrated summaries of safety and efficacy
o    nonclinical overviews and summaries, where applicable
•    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
•    Prepare country specific packs for submission of safety variations within CA, EU, US and other territories as needed
•    Assist in the assessment of clinical and nonclinical documentation with regards to its suitability for supporting new marketing authorisation applications (MAA) or new indications
•    Adherence to Company Health & Safety procedures
•    Participate in training programmes
•    Any other duties as assigned by your Manager 
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 company Affiliates to ensure any requests are answered fully and promptly
Training:
•    Provide training and guidance and act as a mentor to less experienced departmental members
•    Initiate and participate in departmental or interdepartmental process improvement and training initiatives

Requirements:
•    Strategic planning
•    Results and performance driven – deliver results that meet or exceed expectations
•    Sense of urgency – responding to issues and opportunities in a timely manner 
•    Intellectual curiosity – willing to suggest and try new ideas
•    Positive and pro-active approach to business tasks
•    Excellent interpersonal and communication skills 
•    A solutions provider with strong multi-tasking abilities

If you are interested in applying for this role please call Linda on +353 1 2784671 or email Ldunne@thornshaw.com 
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. 

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

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For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

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