Join to apply for the Associate Director, Scientific Writing role at Bristol Myers Squibb.
Position Summary
As an Associate Director, Scientific Writing, you will lead the coordination and authoring of complex regulatory documents essential for global submissions. You will partner with a dynamic development team to integrate scientific, medical, and regulatory insights, setting the standard for documentation excellence across our portfolio. Your role will drive the consistency and efficiency of our submissions worldwide.
Key Responsibilities
1. Author complex clinical documents needed for regulatory submissions, including:
o Protocols
o Phase 3 CSRs
o CTD Summaries
o Risk Management Plans
o Advisory Committee Brochures
2. Engage in strategic document planning to shape messaging and flow of submissions.
3. Develop document prototypes ensuring clarity, logical flow, and compliance with global standards.
4. Collaborate with cross-functional teams, resolve issues, and ensure seamless communication.
5. Mentor and guide a team of authors, fostering a culture of excellence and collaboration.
6. Liaise with external partners to uphold standards and achieve high-quality deliverables.
Qualifications & Experience
* Advanced degree (PharmD, PhD, MD) in a scientific discipline or equivalent experience with a proven track record in pharmaceutical regulatory documentation.
Skills, Knowledge & Expertise
* Proven expertise in creating complex clinical and regulatory documents.
* Ability to analyze and interpret multifaceted scientific data.
* Understanding of global pharmaceutical development and regulatory requirements.
* Exceptional organizational and communication skills, thriving in collaborative environments.
* Familiarity with document management systems and publishing processes.
If you're intrigued by a role that may not align perfectly with your resume but still interests you, we encourage you to apply. You might be one step away from transforming your life and career!
#J-18808-Ljbffr