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Lead Clinical Data Sharing Associate- Home based
- Monitors US, EU and other international regulatory requirements, industry guidelines and societal expectations affecting clinical trial data sharing and communicates changes to functional leadership.
- Provides oversight during the review, preparation and submission of clinical trial data sharing documents.
- Manages vendor(s) for the conduct of clinical trial data sharing activities.
- Ensures quality assurance and quality control of vendor activities.
- Works cross-functionally to evolve global data sharing processes, procedures, systems and related training and communication
- Completes the above in compliance with the applicable regulatory/Sponsor policies and requirements
- Proposes and manages activities that support evolving strategy for clinical trial data sharing
- Prioritizes activities and provides strategic input; anticipates and identifies potential issues and creates contingency plans
- Represents Clinical Trial Data Sharing on internal and external work streams related to automation systems and other proposed changes that may impact policy related to clinical trial data sharing
- Supports Sponsor in the development and implementation of redaction packages to support EMA Policy 70 and 43 and other document/data access regulations or publication requirements (as needed).
- Trains and mentors more junior staff and develop job aids or update user guides as needed.
- Works cross functionally to continuously improve processes, including adjustments to address external changes and evaluation of automation and tools to improve efficiency, accuracy and productivity.
- Effectively communicates the purpose and requirements for clinical trial data sharing including roles and responsibilities.
- May be asked to provide cross functional support across Global Medical Writing and Clinical Trial Data Transparency, if needed.
- Acts as a Lead medical writer on several individual studies or other projects at a simple to complex level.
- Acts as an individual medical writer on simple to moderate submissions projects.
- Provides leads for Business Development opportunities.
- In addition to level 1 experience moderate science or medical related writing experience required
- Advanced degree (M.S., PharmD, Ph.D.) preferred
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
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About PRA Health Sciences:
http://prahs.com/about-praPRA Health Sciences is seeking the best and brightest, nothing less will do. Who we are: We are 11,000 employees operating in 85 countries committed to saving lives, operating in unison. We are the best at what we do and always strive to be better. We are subject matter and therapeutic experts and each realize that every big change in history has begun with a single step. The impact is real and significant, we see it every day. We are making a difference and bringing lifesaving drugs to market faster than ever before and getting them into the hands of the men, women and children who need them. When there is a team of 11,000 moving forward together with a common goal, given the support, tools and technology needed, that single step becomes a movement. Interested? Come join the movement and discover YOUR PRA. PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities
Posted date: 4 months ago
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