Job Description

The Position

Internship/Co-op Associate Submission Manager

Length: 12 months and full time.

Location: Hybrid / Mississauga, ON.

Job description

This exciting internship opportunity is located at the Mississauga, Canada site within the Submission Management Group (SMG) of the global Pharma Technical Regulatory (PTR) organization at Roche. PTR provides technical (CMC [chemistry, manufacturing, and controls]) regulatory oversight for global submissions, changes assessments, and discrepancies. PTR plays a critical role in maintaining the regulatory compliance of Roche\xe2\x80\x99s global portfolio of products. Within PTR, SMG manages the submission process in coordination with technical regulatory teams.

The Associate Submission Manager Co-op/Intern works with regulatory subject matter experts within and across functions to enable the delivery of high-quality CMC regulatory submissions to health authorities worldwide. They apply submission management skills to their work to support global CMC regulatory submissions at the document and data level by providing document and information management support for submissions of medium to low complexity. They provide support to the Submission Manager and Senior Submission Manager.

You will gain knowledge in the following areas:

• Ability to work with a variety of submission types across health authorities globally.
• Understanding of document, content, and information management.
• Develop a data-driven mindset and an understanding of the importance of data quality.
• Become familiar with critical IT business systems used to prepare CMC regulatory submissions.
• Project management skills and ability to develop project timelines.
• Become familiar with documentation in a regulated, GMP environment.
• Improve interpersonal and communication skills by participating in global, cross-functional project teams.
• Learn about agile ways of working while utilizing elements of Scrum.

Specific responsibilities for this position may include:

• Lead a project in operational excellence to generate efficiencies, streamline processes, and improve ways of working.
• Assist in preparing CMC sections (i.e., Module 3) of the common technical document (CTD) dossier for publishing.
• Format technical documents for compliance with dossier formats (e.g., electronic common technical document [eCTD]).
• Edit technical documents for clarity, grammar, spelling, and punctuation; for adherence to applicable regulatory and Roche guidelines; and for consistency within the dossier.
• Manage the flow of information and input of data into the regulatory information management system.
• Collaborate with key stakeholders to provide timely input and guidance to technical development/product teams to achieve company objectives.
• Any other responsibilities as required.
• There will also be opportunities to support other Pharma Technical (e.g., Quality, Supply Chain, Development, and Strategy) teams within Mississauga through the FutureWorks program based on time and interest.

Who you are

• Currently enrolled at a STEM Master\xe2\x80\x99s program (MBiotech UofT OR Master of Biomedical Discovery & Commercialization MBDC McMaster program preferred).
• Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation, and style; familiarity with standard style guides.
• Strong written and verbal communication skills.
• Tech savvy with a keen interest in using technology to increase efficiency.
• Must be highly motivated and able to work independently as well as in a team.
• Ability to interface effectively with a range of different stakeholders.
• Strong organizational and time management skills; the ability to deliver under pressure; and the ability to work flexibly to support changing assignments and priorities in an independent and reliable manner.

Relocation benefits are not available for this job posting.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche\'s truly innovative culture.

As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.

Roche is an Equal Opportunity Employer.

Roche