Temp - Review Committee Specialist - Remote or Sleepy Hollow, NY; onsite

Temp
- Review Committee Specialist
- Remote or Sleepy Hollow, NY (onsite preferred)

Sleepy Hollow, NY 6 Months Ad/Promo Life Sciences

Orbis Clinical is seeking a Temp
- Review Committee Specialist located in Sleepy Hollow, NY or Remote for initial 6-month contract with possible extension up to 2-years but not guaranteed.

Job Title:

Temp
- Review Committee Specialist

Location:

Remote or Sleepy Hollow, NY (onsite preferred)

Contract:

Initial 6-month contract with possible extension up to 2-years but not guaranteed

Build our future together:

The Review Committee Specialist role is the lead for coordinating company's promotional Review Committee (Medical, Legal, and Regulatory) activities and for ensuring the promotional review processes are conducted both in a highly compliant manner and in a timely and efficient manner. This role is responsible for tracking promotional materials from inception through approval, maintaining appropriate systems and documentation files, and coordinating any associated regulatory submissions.

Additionally, this role is tasked with maintaining and enforcing associated operating procedures, managing high-quality committee meetings, ensuring continued compliance with all laws, policies and procedures, and providing guidance to promotional material sponsors on submission of high-quality and compliant work.

Discover your role:

• Guide promotional material sponsors on review cycle timelines and assist with planning from submission for review through to approval.
• Review promotional materials submitted for accuracy; verify and route submissions appropriately; provide proactive guidance on submissions where needed prior to Review Committee approval.
• Serve as the facilitator for assigned Review Committee meetings ensuring that reviews are conducted according to all policies and procedures and that all outcomes are accurately recorded.
• Ensure that all required revisions are incorporated in to all impacted materials in a timely manner.
• Help to coordinate the submissions of materials to the FDA Office of Prescription Drug Promotion ("OPDP") as required.
• Proactively manage all files and systems needed to support the review process.
• Prepare for and actively participate in any and all QA checks and /or audits.
• Help to manage all associated processes including communications with vendors, system updates, and the incorporation of enhancements.
• Remain abreast of changes in the marketplace and new guidances as issued.

This role requires:

• Minimal educational requirements:
  Bachelor's Degree
• Have excellent written, verbal, and interpersonal communication skills and the ability to effectively interact with all levels both internal and external to the company in order to establish credibility with professionals on the project teams.
• Have strong presentation and critical thinking skills.
• Handle multiple projects and priorities with exceptional organizational and time management skills (both project and self)
• Thrive in fast paced entrepreneurial organizations; expert in dealing with ambiguity and uncertainty

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $45.00 - $55.00 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.