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.
...Job Description Job Description About the Role: The Off Duty/Retired Police Officer role is designed to leverage the extensive law enforcement experience of retired or off-duty officers to enhance security and safety within the transportation and warehousing industry...
Join to apply for the 3D Technical Artist role at CommonSpirit HealthJob Summary and ResponsibilitiesThe Neuroscience Publications Department at Barrow Neurological Institute leads the academic publishing industry in author services focused entirely on the neurosciences...
...Opportunities Fun and Energetic Environment Discount on Products and Services Job Summary We are seeking a talented Hair Stylist/Barber to join our team, providing customers with flawless haircuts and hairstyles and helping them to look their best! As a...
...Delivery Driver Job Description If you like working with a fun team, love our queso, have a great personality & enjoy interacting with... ...hospitality-oriented individuals! POSITION SUMMARY As our catering delivery driver you will be the face of QDOBA representing...
...LHH Recruitment Solutions has partnered with a growing organization, and they are seeking a motivated Food Safety & Quality Assurance (FSQA) Manager to join their team. This is a high-impact role for a growing food manufacturing company to drive excellence in quality...