In this role, incumbent will be expected to provide Medical Writing leadership for clinical development, registrational, and LCM programs. Serves as lead Medical Writer for key programs. Coordinates medical writing support for programs with internal and contract writers. Additionally, must possess the ability to guide and assist medical writers in the writing of documents that are components of clinical/regulatory approval applications for new biologics or NME applications. Documents include: Sections of clinical trial applications, Annual Reports, and BLA/NDAs, Protocols and Protocol Amendments, Model Informed Consents, Model Privacy Consents, Investigator Brochures, Clinical Study Reports, and Expert Reports and other documents as appropriate. Additional skills: must be a strong technical leader, manage with excellent scientific, strategic and customer focused leadership. Partner with Clinical Operations and R&D team members to ensure completion of high quality, timely, clinical documentation. Expected Qualification: Masters or PhD in biology or related discipline. Equivalent combination of education and experience considered. 7+ years of related experience in biotech or pharmaceutical environment. Must have strong scientific and operational background. At least 3 years of experience managing staff.
...We are seeking an energetic, dedicated person to fill a Certified Medical Assistant position at Kidney & Hypertension Clinic of Alaska in Anchorage, AK. Primary Responsibilities: Greets patients and visitors in a prompt, courteous and helpful manner. Primary for...
...requires someone who is dependable, organized, and committed to safe driving practices. Responsibilities Operate a company box truck or other non-CDL vehicle to make local deliveries. Load and unload products safely and efficiently. Inspect delivery orders...
...Care is looking for a LPNs to join our Delaware County Skilled Nursing team. We believe our clients and their families deserve the... ...near your home ~$1,200 nurse referral bonus What makes private duty nursing different than home health visits? Offers traditional...
...adequately with customer representatives in the field. Ability and willingness to serve as a mentor for Installers and/or junior Field Technicians. Work closely with lead technicians, project managers and team members to ensure successful delivery of excellence within...
Description: Thompson Tire and Service offers a unique opportunity for the right individual to join our team as an Inside Sales and Office Administrator. Prior experience in the tire industry is not required; however, we are seeking someone with strong organizational skills...