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.
...rest or spend time with family ~ Flexible scheduling that works around school, family, and other commitments ~ Paid training ~ Free drinks every shift ~ Free or discounted food during breaks ~401(k)~ Paid Time Off ~ Leadership development and clear...
...responsible for ensuring that the building and facilities are clean, maintained, and presentable always. This role requires a proactive... .... # Any other duties as mandated by the scope of the contract. # Communicate effectively any irregularities, equipment or building...
...stewardship, Skip Barber Racing School is the market leader in a fully integrated system of racing schools, race series, race teams and driving schools at iconic tracks across the United States. Skip Barber has placed drivers on the podium in nearly every facet of...
...Innova Solutions has a client that is immediately hiring for a Medical Editor. Position type: Full-time- Contract Duration: 12 Months Location: 100% remote As a Medical Editor you will: Develop annotated reference packs for promotional materials...
...safeguarding the environment, and creating a long-lasting, positive impact on the communities where we do business. Are you with us?!?The Paper Mill Supervisor has overall responsibility for managing the daily activities of on-shift crews in the paper mill, including directing...