Submission manager

As a Submission Manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

ROLE SUMMARY:
Provides an interface to Sponsor Regulatory and Global Product Development (GPD) partners within
designated Sponsor Business Units, offering project leadership and expertise in the logistics involved
with execution of regulatory CTA and Central Ethics submissions to regional partners and selected
Health Authorities. The Regional/Global CTA Submission Manager (CTA-SM) is accountable for working with contributing Sponsor business lines to lead operational submissions execution for designated CTAs.
They may operate as regulatory operational Subject Matter Expert for a CTA and drive submission
teams towards the timely delivery of globally compliant submission-ready components.

ROLE RESPONSIBILITIES:
• Drive global submission management strategy and activities for assigned protocols. Partner with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required 
• Lead and attend relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
• Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
• Liaise with Sponsor Core team, SSU and Study Management, regarding essential core documents and local documentation as needed from relevant supplier lines across both HA and EC submission and translation processes
• Prepare, review and support submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
• Responsible for the co-ordination of translations for core documents required for submission
• Manage the compilation for core package build, contributing to CTA and authoring documentation as required
• May act as local country liaison when required
• Escalate, inform, and resolve any issues that may impact submission builds or the logistics of
global submission delivery to regional and local partners or Health Authorities.

• B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology
(desirable); equivalent relevant professional experience will be considered.
• In-depth understanding and proven execution of CTA and Central Ethics
processes globally

*At least 5 years of experience in start up area; experience as Lead or Manager is an asset
• Proven technical aptitude and ability to quickly learn and use new software,
regulations and quality standards

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.