Contributes to development of global regulatory documentation strategy and execution of tactics. Conceptualizes and develops medical communications for message-driven, concise reviewer-friendly clinical documents in order to support regulatory agency review. Coordinates medical writing/regulatory submission progress against global regulatory strategic communication plans. Writes or co-ordinates writing and reviews of clinical trial reports, narratives, clinical trial protocols, local working instructions, submission documents (ISS, ISE, CO, RMP), investigator brochures, annual IND updates, and other documents as needed. Reviews DPP and SAP as needed. Estimates resources needed and communicates with Director of Medical Writing. Establishes target dates for completion of assignments. Communicates with management when timelines are threatened. Establishes and enforces quality standards for documents. Adherence to Company SOPs, Best Practices, Working Instructions, as well as the accepted industry guidelines and regulations governing regulatory documents and submissions to global health authorities. Skills: The incumbent must have relevant medical/scientific knowledge, project management skills, analytical skills, knowledge of drug development and regulatory requirements, excellent written communication skills, computer skills, and ability to work as part of a team. The above are necessary to provide the depth and breadth of understanding of drug development issues. Education: College degree plus a minimum of 6-8 years experience in medical writing, preferably in the pharmaceutical industry. Evidence of the skills necessary to manage submissions. Evidence of depth of knowledge in multiple therapeutic areas desirable. Advanced degree (eg, MS, PhD) or other related qualifications (eg, Pharm D, BSN) are desirable.
...the budget and strategic plan.- Maintain and develop various financial models and standard templates distributed for use by all of Finance within the Division or PCC and ensure quality, accuracy and focused analytic review.- Responsible for day-to-day review and...
...Do Work alongside Sales Operations to administer key go-to-market business systems, including Salesforce, Outreach, Qualified, Zendesk, Hubspot, Looker, Gong.io Build and deploy automation (flows), validations, and applications in Salesforce Implement new systems...
...and debugging/reproducing customer problems Maintain accurate and up-to-date project status and customer support data within Zendesk and Monday.com Build relationships with our customers to understand their desired business outcomes Be the NetBox expert...
Environmental Scientist/Geologist (Houston, TX) The position is for a mid to junior-level Environmental Scientist/Geologist to join our company and assist with our projects that requires completing the following task: Phase I ESA and Phase II Site investigations ...
...The Staff Nurse will be responsible for: Caring for post-surgical pediatric patients. Working collaboratively in a family-centered environment. To qualify, you must have: A Bachelor of Science in Nursing. A minimum of 2 years of pediatric inpatient experience...