Position Overview: Supporting the Phase 2+3 team on various tasks related to submissions and integration work. The team is preparing for a FEB2025 submission and are working to build up the team to help manage the workload. We are looking for Independent Contributors with the ability to lead projects/studies but must be comfortable in a 100% hands-on position.
Lead responsibilities will be delegated on an "as needed" basis so we cannot guarantee the new joiner will be delegated these responsibilities.
If the candidate has recently held the title of Manager or higher, they need to have been 70-80% hands-on and able to speak in detail about their specific hands-on responsibilities. If their main responsibility was oversite/review/validation type work and they assisted with hands-on tasks as needed, they won't be a fit.
Requirements:
In-depth hands-on experience with ADaM/TLF programming (including creating ADAM specs at the domain and variable levels), creating submissions documents/reports, and efficacy programming are required.
Recent and thorough experience supporting or leading submissions to regulatory agencies. Should have in-depth exposure to creating packages, Pinnacle 21, eCDT package creation, Defines, SDRG/ADRG, etc.
Ideal candidates will have experience leading submissions but not required. Just need to be actively hands-on/involved in the submission process (creation of packages).
Candidates who have only reviewed the submissions documents will not be con sidered
Minimum 6 years for Senior title, 10+ years experience for Principal title with 3 years of recent lead experience
TA: Nephrology, Kidney, Keratin related study experience. Specific TA experience is preferred but not required
Work Environment:
Must be comfortable working in a fast paced, scratch programming environment, and willing to wear multiple hats.
Excellent communication and problem-solving skills required.
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