Senior Coordinator, Regulatory Operations
Job Description

Are you looking to make a difference in a patient’s life?  At Innomar Strategies, a company of AmerisourceBergen, you will find an innovative culture that is patient focused and dedicated to making a difference.  As an organization, we are united in our responsibility to create healthier futures.


The Senior Coordinator, Regulatory Operations reports directly into the Manager, Regulatory Operations. This person has the responsibility to ensure that our clients (TPI Regulatory department and external clients) are fully supported in all regulatory submissions with some assistance from their manager. The candidate is expected to function with a degree of independence and is responsible for creating e-compliant documents and submissions, quality checking, troubleshooting, and managing projects as a whole with help from the manager as required. This person will be formatting in Microsoft Word, making PDF files e compliant using specialized Adobe Acrobat plug-ins, using e-validator to quality check their work and utilizing the e-submissions builder to prepare high quality submissions for sending to U.S and Canadian government agencies. They will be client focused and always represent themselves in a professional manner (both written and verbally) when interacting with all internal and external clients.

 
PRIMARY DUTIES AND RESPONSIBILITIES:
  • Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients.
  • Use various internet document transfer sites to download client files and upload files ready to be sent back to our clients.
  • Use, manage and maintain submission files on the company shared drive and submissions drive as per company standard.
  • Create and format e-compliant documents as per clients’ needs using Microsoft Word, Adobe Acrobat (and associated plug-ins), Excel, Power Point.
  • Create eCTD submissions using the eCTD submissions builder, validation software and electronic submissions viewer.
  • Create NeeS, and paper submissions as needed.
  • Quality checking all submission types with little assistance from manager.
  • Trouble shoot and fix issues, on a document and submission level.
  • Send eCTD submissions via the ESG and CESG gateway.
  • Burn CDs/DVDs, create appropriate labelling.
  • Create courier waybills, pack and ship submission materials as needed.
  • Enter time into Paymo, or company chosen database, on a daily basis.
  • Attend and contribute to weekly department meetings.
  • Maintain professional regulatory and documentary knowledge in order to provide effective consulting advice.
  • The Senior Coordinator will be responsible, when requested by their manager, to train other junior department members. 
  • The Senior Coordinator may be asked to complete additional and other department services as required.


  • B.Sc in life sciences and/or typically 4-6 years of daily working experience in Regulatory Operations
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
  • Has at least 2-3 years of daily hands-on Regulatory Operations experience minimum.
  • Has a good understanding of a wide variety of submission types (Cdn and U.S.).
  • Excellent written and verbal communication skills.
  • Excellent computer skills in Microsoft Word and Adobe Acrobat. 
  • Experience with Excel and Power Point.
  • Good knowledge of Non-eCTD electronic Submissions (NeeS) and eCTD software.
  • Must have a good understanding of Regulatory Operations industry guidance’s. A general understanding of Regulatory Affairs industry guidance’s is an asset. 
  • Ability to multitask and balance several projects at once.
  • Has a complete understanding of client confidentiality and the importance not to cross project information with one another.
  • Results oriented with proven time management, organization and prioritizing skills.
  • Must have an acute ability for attention to detail.
  • Ability to work well individually and as a team.
  • Has a positive attitude and works for the greater good of our clients, the team and the company.
  • Is responsible for company supplied hardware and software; contacting Innomar IT when needed for assistance.
  • Ability to obtain individual and department goals.
  • Excellent project management skills – expected to see all projects through to completion. Expected to be able to take on, as assigned, with some assistance from manager. Expected to coordinate with RA and Regulatory Operations team members, and keep them apprised on submission status, in order to complete all projects on time, if timelines will not be met and/or help is required the manager must be informed. Able to identify, trouble shoot and fix any issues which arise with the help of their manager. Correct document placement within the eCTD structure is understood. Submissions should have few errors upon first validation. Able to identify, at all times during project, any progress on any specific task. Works in coordination with manager for any project management meetings needed. Expected to keep accurate, up-to-date records as per company/department guidelines.
  • Ability to consistently meet extremely tight deadlines.
  • Excellent conflict resolution capabilities and ability to spearhead issues (professionally) and successfully solve as they arise.

We offer competitive total rewards compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive and will meet the needs of our associates.

  • Competitive compensation packages
  • Comprehensive health and dental plans
  • Flexible & remote working options
  • Employer RRSP-matching
  • Online peer-to-peer recognition program
  • Corporate discounts with multiple establishments, including fitness centers
  • Health & Wellness program with onsite yoga and massage therapy

AmerisourceBergen is a publicly traded Fortune 10 global healthcare solutions company and is one of the world's largest pharmaceutical services companies. Powered by our associates around the world, we provide pharmaceutical products and business solutions that improve access to care.  We operate the backbone of the healthcare supply chain. We drive the future of local care delivery.  We guide medical innovations to market.  We create healthier futures.



Job Requirements

 

Company Overview

Innomar Strategies was founded in 2001 around the kitchen table of our current president, Guy Payette, and his partners. The company originally specialized in market access and reimbursement consulting, and gradually expanded its capabilities to include fully integrated patient support programming, nursing support, and specialty logistics. By the end of 2008, the company had grown to have over 450 associates.

In 2009, AmerisourceBergen acquired Innomar Strategies further establishing the company’s expertise in specialty pharmaceuticals. As part of AmerisourceBergen, Innomar Strategies is connected with a global leader in healthcare with over $135 billion of annualized revenue and 18,000 associates. AmerisourceBergen has an established history of delivering innovative programs and solutions across the pharmaceutical supply channel.

With over 1,200 associates and a nationwide footprint, Innomar Strategies is Canada’s leading service provider to specialty pharmaceutical and biotech manufacturers. Innomar is differentiated by their Integrated Service Model, which provides customized solutions to improve product access, increase supply chain efficiency, and enhance patient care. Manufacturers trust Innomar Strategies to deliver innovative brand solutions throughout the product lifecycle.