Principal Regulatory Documentation Scientist

Canada, Ontario, Mississauga

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Title: Principal Regulatory Documentation Scientist

Department: Product Development Regulatory Documentation

Location: Mississauga Head Office

Duration: Full-Time

We currently have an opportunity for an exceptional Principal Regulatory Documentation Scientist to join our team.  This is a great opportunity to combine your scientific knowledge and writing skills in an important role with one of the world's leading healthcare companies. You will be working as a strategic partner with global drug development teams to bring novel pharmaceutical products to patients worldwide through planning and preparing a broad range of regulatory documents. Our scope encompasses the entire clinical lifecycle and covers a range of therapeutic areas to write Module 2 clinical documents, INDs, risk management plans, briefing packages and many other document types.  In addition to authoring individual documents, you may be the single point of contact for a specific molecule or project within the portfolio and provide broader oversight and management of the regulatory documents to the global team. 

In building a strategic partnership, you will liaise with colleagues in safety science, biostatistics, clinical science, and regulatory affairs, among other functions to maintain broad oversight and planning.  In addition to writing or substantially editing regulatory documents in accordance with Roche standards, the Principal Medical Writer manages the preparation of a suite of regulatory documents, and leads the writing/editing team working on the respective regulatory documents.  The Principal Medical Writer also contributes to best practices, compliance and continuous improvement activities within the department, and mentors/trains more junior writers.  

Who you are

You have a Ph.D., MSc., BSc. or equivalent in a biomedical discipline or a qualification in pharmacy, nursing, or another healthcare discipline. You should have extensive experience of writing/managing complex regulatory documents and global filing dossiers in the pharmaceutical/biotech industry, key leadership, strategic thinking and project management skills; the ability to manage and influence stakeholders without authority, be able to work independently and deal with ambiguity, ability to adapt to changes, lead change, and accept changes as positive; and knowledge of Good Clinical Practice and/or Pharmacovigilance guidelines.  In addition, you are a clear communicator, comfortable leading cross-functional teams and groups of writers, and have excellent organizational skills. 

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.