Title: Regulatory Documentation Scientist (Multiple Roles Available)
Department: Product Development Regulatory Documentation
Location: Mississauga Head Office
Duration: Full-Time and Contract available
We are hiring a multiple levels.
-Regulatory Documentation Scientist
-Senior Regulatory Documentation Scientist
As the Regulatory Documentation Scientist you are responsible to prepare regulatory documents for submission to regulatory authorities within subject area (clinical/safety). The Regulatory Documentation Scientist takes accountability for delivering regulatory documents, working effectively and closely with key content owners in the relevant functions. You will apply scientific writing, editing, document and project management expertise and contributes to the functional excellence of regulatory documentation through process management.
- Prepares (writes or substantively edits) regulatory documents in accordance with applicable regulatory guidelines/Roche standards/SOPs, ensuring high scientific quality and consistency with other documents where appropriate
- Liaises with document contributors to gather information (including Licensing partners where relevant)
- Plans and creates timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate.
- Resolves issues, errors, or inconsistencies in data with contributors as appropriate
- Reviews documents for: organization/clarity/grammar/scientific standards/internal consistency (e.g., between text and data displays).
- Manages the review process, including leading/coordinating adjudication of review comments and incorporating review comments
- Ensures that documents are published in collaboration with Regulatory Operations and that the document is approved by the single accountable signatory
- Obtains and applies knowledge of Roche and regulatory guidelines, procedures and best practices across relevant documents
- Participates as a member of key functional/cross functional Team (s) (e.g. Regulatory Affairs Functional Team, Safety Team etc), ensuring that Teams adequately plan for document deliverables
- Actively contributes to best practices and continuous improvement within Regulatory Documentation
- Keeps informed on regulatory, scientific & medical issues important to drug development, assigned products, and disease/therapeutic areas
- Minimum of Undergraduate degree (life sciences, English, or communications disciplines strongly preferred)
- Graduate degree preferred
- Minimum 1-3 years’ of experience in regulatory affairs or related functions in drug/biologics development/manufacturing.
- Previous authoring and/or editing experience with regulatory documentation ethics is required.
- Outstanding attention-to-detail
- Has working knowledge of the multidisciplinary functions involved in pharmaceutical/biologics product development, e.g., clinical development, clinical operations, biostatistics, commercial operations, etc.
- Good project management skills: can prioritize multiple tasks and goals to ensure the timely, on-target and within-budget accomplishment of such
- Good interpersonal, verbal communication and influencing skills: can influence without authority
- Strong written communication skills
- Good business presentation skills: is comfortable and effective when presenting to others, internally or externally
- Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
- Good judgment and decision-making skills: knows how to make trade-off decisions while balancing ethics and efficacy
- Works well within teams and is effective in collaborating with others internally and externally
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
- Fluent English and other language skills as needed
Qualified candidates are encouraged to submit a cover letter and resume by: October 23, 2019
This position is not car eligible.
This position is not eligible for relocation support.
This position is open to applicants legally authorized to work in Canada.
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.
NOTE: All employment is conditional upon completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
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.