Key Responsibilities The Director, Medical Writing will lead document strategy, overseeing authoring, review processes, and writing assigned documents. They will coordinate internal and external writers, establish best practices for high-quality preclinical summaries, clinical, and regulatory submission documents, ensuring compliance with ICH/GCP/regulatory guidelines for global health authority submissions such as IND/CTA/BLA. Lead planning, authoring, and review of regulatory documents (e.g., Protocols, CSRs, IBs, briefing documents). Evaluate and review documents generated by internal and external writers for consistency, formatting, and scientific accuracy. Engage with external stakeholders including vendors and thought leaders as needed. Manage timelines for document development and approvals. Assess medical writing needs and ensure resources are adequate for timely completion. Oversee document management from draft to final version, including review coordination and style adherence. Support development and improvement of best practices, SOPs, and templates. Lead matrix teams effectively. Maintain a track record of developing high-quality scientific and regulatory documents such as protocols, study reports, and responses to regulatory questions. Deep knowledge of drug/biologic development and GxP principles. Strong leadership, planning, and project management skills . Collaborate effectively to resolve comments and meet deliverables. Manage multiple projects in a fast-paced environment, adaptable to changing priorities. Excellent communication skills and attention to detail. Self-motivated with the ability to work independently. Proficiency in Microsoft Office and electronic document management systems. Experience responding to audits. Educational background : Bachelor’s in a scientific discipline; advanced degrees preferred. Experience : 8-12 years (Bachelor's level) or 6-8 years (advanced degree) in medical/scientific writing within pharma/biotech.
...advanced display in the world. We design, build and service cutting-edge equipment that helps our customers manufacture display and semiconductor chips the brains of devices we use every day. As the foundation of the global electronics industry, Applied enables the...
SPORTS STAFFLeads and participates in a variety of island Sports activities and duties such as competitions, tournaments, sports instruction of beach volleyball, basketball, soccer, bean bag toss, sand billiards, themed parties, pier greets and degreets. by performing...
...to fill multiple positions which include document preparation, data entry, document scanning... ...Drive, Royersford, PA 19468 (no remote work)~ Monday-Friday - Full-time (OT may... ...Quality control of digital images Review of the images and information and inputs...
...of the organization. ~ Excellent time management, organizational, and conflict resolution skills. Company Overview Keurig Dr Pepper (NASDAQ: KDP) is a leading beverage company in North America, with a portfolio of more than 125 owned, licensed and partner brands...
...IT Infrastructure Project/Program Delivery Manager &##128226; THIS IS A W2-ONLY ROLE NO C2C, NO 3RD-PARTY CANDIDATES (All submissions from agencies... ...5 days/week for first month, then 4 days onsite + 1 day remote Our client is seeking an experienced IT...