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 considered
  • Minimum 8 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. 

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.