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.
...Job Description Job Description We are a leading provider of Home Care Services throughout New York State. We are looking to further expand our team and bring on dedicated, reliable Home Health Aides (HHA) and Personal Care Aides (PCA). Join the Family & Apply NOW...
...Rogar Management & Consulting of Florida, headquartered in South Florida, is looking for experienced Heavy Equipment Operators to join our construction team. This position requires travel to job sites throughout the State of Florida. We are looking for reliable,...
...communities.The Role Help us transform and bring innovation to Drug Safety and Pharmacovigilance! Veeva is looking for senior system... ...our customers throughout the implementation programs.This is a remote, full-time permanent role with Veeva. It is customer-facing, and...
Description CHRISTUS Santa Rosa Hospital - San Marcos, which originated in 1923 as Hays County Soldiers, Sailors and Marines Memorial Hospital, opened at its current Wonder World Drive location in 1983.Our staffof more than 700 Associatesworkswith more than 300 active...
...Customer Service Representative We are seeking a Customer Service Representative to act as a primary point of contact for customers. This role... ...with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or...