Senior Principal Medical Writer all genders
Senior Principal Medical Writer all genders
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Your role: As Senior Principal Medical Writer you will lead the Medical Writing effort for global priority programs. The role leads independantly MW deliverables for complex global programs such as Protocols Clinical Study Reports IBs Briefing Books Clinical Summaries Pediatric Plans responses to authorities etc. and ensure alignment of messaging. You act as the Lead Writer/oversight for clinical sections of eCTDs for global market approval and represent department on clinical teams lead documentrelated meetings review statistical analysis plans.
The role contributes to overall project management and crossfunctional working groups to facilitate efficient development and finalization of regulatory documents for submission and provides document strategy and resource needs for an indication/program. The Senior Principal Medical writer oversees work of vendors supporting program deliverables and attends governance meetings for protocol discussions. The role proactively contributes to development and implementation of MW best practices and improvements. We are calculating travel up to 10
for this role.
Who you are:
- MinimunBS in a scientifc or writing discipline; MS or PhD preferred
- Minimun58 years related experience
- Strong communication and organizational skills
- Strong Clinical Trial Development knowledge
- Thorough understanding of drug development and strategy for regulatory submissions
- Shows innovation and ability to implement change
- Ability to coordinate work of multiple writers and vendor resources
- Expert in Word/Adobe/Electronic document management systems
Required Experience:
Staff IC
Employment Type
Full Time
