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 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 the assistance from their manager. The candidate will be trained and then responsible for creating e compliant documents and submissions, quality checking, troubleshooting,
and managing projects as a whole with the help of their manager. 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 with support from their manager. 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 as the need arises.
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 smaller, basic daily submissions until experience is gained to progress further.
- Trouble shoot issues on a document level independently. Troubleshooting on a submission level with the help of your manager.
- 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.
- Obtain and maintain professional regulatory and documentary knowledge in order to provide effective consulting advice.
- The Coordinator may be asked to complete additional and other department services as required.
- B.Sc in Life Sciences or typically 3-5 years of daily working experience in Regulatory Operations.
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:
- Excellent written and verbal communication skills.
- Excellent computer skills previous experience with Microsoft Word and Adobe Acrobat is an asset.
- Some previous experience with Excel and Power Point is an asset.
- Experience with Non-eCTD electronic Submissions (NeeS) and eCTD software an asset.
- Knowledge of industry guidance (Regulatory Operations related and some Regulatory Affairs related), would be an asset to have.
- Ability to multitask with the aim of balancing several projects at once.
- Must have a good 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 as expected to see all projects through to completion. Expected to have the ability to coordinate with other team members in order to complete all projects on time and advise manager if timelines will not be met and/or help is required. Able 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 benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.
• 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
Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.
Innomar Strategies, a part of 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.
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