Associate Submission Manager (Editor- CMC)

Title: Technical Editor – CMC (Submission Manager)

Department: Pharma Technical Regulatory (PTR)- Global

Location: Mississauga Campus

Hiring for 2 Levels

Associate Submission Manager

Submission Manager

Objective:
The Submission Manager delivers high quality regulatory submissions to Health Authorities worldwide. They have responsibilities for varying regulatory submission projects, as business needs dictate. They apply submission management skills to their work and contribute to the daily business of Pharma Technical Regulatory submissions. They have the knowledge and ability to work with all submission types across Health Authorities globally.

Responsibilities:
Support and provide coordination, compilation and submission management in the preparation of new and existing regulatory applications, in compliance with health authority regulations

Must have expertise and or capability to manage submissions of all types and complexities globally

A key member of local filing teams, provide ongoing expertise regarding regulatory submissions and guidance on compliance, timing and other relevant matters

Edit complex technical documents for clarity, grammar, spelling, and punctuation. Ensure adherence to applicable regulatory (e.g., CTD) and Roche guidelines

Facilitates communication and collaboration to meet submission timelines and plan future requirements.

Manage the flow of documents via document-sharing systems (e.g., SharePoint) and document management-systems (e.g., Documentum) and ensure version control throughout the submission generation process (writing, review, and internal approval)

Communicate with technical subject-matter experts to ensure content is delivered according to schedule and provide status updates. Coordinate and provide training on documentation systems and tools and collect relevant submission related data

Facilitate submission reviews and review adjudication meetings and perform live editing to capture stakeholders’ decisions

Collaborate with internal partners (e.g., Regulatory Publishing, Project Management, Business Systems, etc.)

Providing input on future system enhancements, business process updates, and submission model documents

Qualifications:
Minimum BA or BS (or equivalent) in English, biology, chemistry, pharmacy, or related field

Strong track record as an editor and project manager, including at least three years of professional experience, preferably in a scientific or technical field. Previous experience with regulatory documents (e.g., in CTD structure and other ICH, FDA, and EMA guidelines) and global submission dossiers or in the biotech or pharmaceutical industry is beneficial

Ability to communicate clearly and professionally, orally and in writing, in English.

Bilingual in German is an asset.

Expert-level use of Word, Excel, PowerPoint, and Adobe Acrobat and experience with document management systems (e.g., Documentum) and document sharing systems (e.g., SharePoint)

Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders, including PTR submission leads, scientific subject-matter experts, reviewers at all levels and colleagues located in other countries

Strong organizational and time management skills and ability to deliver under pressure and work flexibly to support changing assignments and priorities in an independent and reliable manner

Qualified candidates are encouraged to submit a cover letter and resume by June 28, 2021.

This position is not eligible for relocation support.

NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.

Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process

AGENCY NOTICE: Please note that Roche Canada does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Services Agreement with agency/recruiter, Roche Canada will not consider or agree to payment of any referral compensation or recruiter fee. In the event a recruiter or agency submits a resume or candidate without a previously signed agreement, Roche Canada explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.