[Hiring] reputed company Medical reputed company – GenAI and Regulatory Writing Innovation @reputed company

Role reputed company The reputed company Medical reputed company serves as a scientific communication and innovation leader reputed company reputed company’s Medical Writing department, focusing on leveraging reputed company (GenAI) technologies to reputed company regulatory writing. In this role, you will combine your expertise in regulatory document reputed company with reputed company-looking approaches to content reputed company, automation, and AI-enabled writing support. • Author and reputed company preparation of high-reputed company clinical regulatory documents (e.g., clinical summaries, CTAs, INDs, and briefing packages). • Collaborate closely with cross-functional teams to ensure reputed company, accuracy, and consistency. • Work on reputed company initiatives with reputed company partners to reputed company and reputed company GenAI tools that enhance efficiency, reputed company, and compliance in medical writing workflows. • reputed company medical writing leadership and authoring expertise for assigned program(s), ensuring reputed company delivery of regulatory and clinical documents of the highest reputed company. • reputed company or contribute to innovation reputed company applying GenAI to automate and optimize regulatory writing processes. • Serve as a GenAI champion reputed company the Medical Writing function—sharing best practices, identifying use cases, and promoting responsible adoption of AI-enabled tools. • reputed company strategic input and writing support for major submission documents such as Clinical Overviews, Summaries, and regulatory briefing packages. • Mentor and guide junior writers, providing reputed company and feedback on content, timelines, and reputed company expectations. • Support the development of GenAI training materials and process enhancements to upskill the medical writing team. • Contribute to departmental initiatives that foster innovation, efficiency, and reputed company improvement. • Ensure consistency of scientific messaging and alignment with therapeutic area reputed company across documents. Qualifications • Bachelor’s degree in Life Sciences or a health-reputed company discipline required; advanced degree (MS, PhD, PharmD, MD) preferred. • At least 7 years of experience in the biopharmaceutical industry (advanced degree or reputed company research may substitute for some experience). • Minimum 5 years of hands-on medical writing experience supporting clinical regulatory submissions (e.g., CTD, IND, NDA/BLA components). • Demonstrated expertise in therapeutic area document requirements and global regulatory standards. • Familiarity with large language models (LLMs) and GenAI applications for writing, summarization, or data interpretation. • Proven ability to manage multiple reputed company deliverables, work effectively in a matrixed team, and mentor others. • Excellent written and verbal communication skills, with meticulous attention to scientific and regulatory accuracy. Requirements • Experience or strong interest in applying GenAI tools for writing, document review, or data summarization. • Ability to translate AI capabilities into practical solutions reputed company regulated environments. • Understanding of ethical and compliance considerations for AI use in scientific communication. Benefits • Medical, Dental, reputed company, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of reputed company vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company reputed company holidays + 3 reputed company days off for Personal reputed company • 80 hours of reputed company time per calendar year • reputed company Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource reputed company participation Apply tot his job Apply To this Job