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.
...orderly dining room and the guest service area in an assigned restaurant located within the Hershey Lodge. As a Part-Time Team Member... ...perks like FREE admission and parking to Hersheypark, discounts on food & shopping, and more as soon as you receive your Employee ID!...
Tender Touch Rehab Services is seeking a caring Physical Therapist Assistant to support high-quality rehab services for seniors in skilled nursing and long-term care. Working under the direction of a licensed PT, you will carry out individualized treatment plans, lead therapeutic...
...JetBrains, Zapier, and Wish.About the roleE2B is looking for a Technical Copywriter to turn complex product and engineering ideas into... ...-quality technical content at a consistent cadence.Youll write comparison, migration, and integration pages; create docsadjacent...
...impact on the world.We are seeking an experienced Compensation Business Partner to collaborate closely with business leadership, Recruiting,... ...world working for us. If you are creative and autonomous, we want to hear from you!Your base salary will be determined based on...
..., gain meaningful experience, and work where your support matters every day. These roles support students with a range of special education needs, including mild, moderate, and severe needs. \n Dont wait! Connect with a recruiter today and take the first step toward...