Associate Director - Principal Medical Writer
- Create high-quality regulatory-compliant clinical documents supporting product life cycle
- Ensure timely delivery while maintaining compliance with standards
- Lead implementation of new digital technologies and AI solutions
- Drive process improvements for efficiency gains
- Prepare registration dossiers and Health Authority responses
- Monitor and implement regulatory documentation requirements
- Lead cross-functional initiatives as Subject Matter Expert
- Drive change management within writing teams
- Update relevant stakeholders on project progress and needs
- Maintain accurate information in planning, tracking, and reporting tools
- Ensure consistent communication across ClinDoc functions
- Oversee writing activities across teams and vendors
- Mentor junior writers and review contract work
- Develop training programs and documentation standards
- Build effective relationships with stakeholders and partners
- Six+ years as medical writer or equivalent specialist role
- Proven track record leading multiple clinical documentation projects
- Expert in clinical documentation preparation
- Demonstrated expertise in clinical development processes
- Strong understanding of clinical study methodology and basic statistics
- Knowledge of regulatory environment
- Proficient in document management systems and authoring platforms
- Strong attention to detail and deadline management
- Excellent organizational and follow-up abilities
- Proven ability to work independently and in global teams
- Expertise in electronic document management and Microsoft Office
- Proven experience in implementing emerging innovative digital technologies, including content reuse strategies and AI-assisted document authoring solutions.
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic
partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability
for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or
any other characteristic protected by law. #GD-SA
#LI-SA #LI-Remote #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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