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.
Kaiva Tech, LLC is seeking a Medical Editor in the DC Metro Area .Clearance : Ability to obtain a Public TrustWorkplace Type : Currently 100% remote. Please be aware that the workplace type allowed is approved by the client and is subject to change dependent on client...
...Placement (Full-Time, Permanent) Build Your Career in Heavy Construction Are you hard-working, reliable, and looking for a real... ...construction projects in Charles Town, WV . No prior heavy civil experience is required. If you bring a strong work ethic, rock-solid...
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...QA Engineer Full Time Location: 100% Remote or McLean, VA Candidates must be able to obtain and maintain a US Public Trust... ...where applicable. At least five (5) years of related functional experience. Discover Technologies is an Equal Opportunity employer...