Technical Writer, Clinical Research - Nanaimo, British Columbia
Tilray is a federally licensed producer of medical cannabis. We are committed to setting the gold standard of care and excellence in our industry. We believe that commitment starts with a great work environment and benefits for our associates.
Looking to develop your career at the forefront of a rapidly expanding industry?
The Technical Writer, Clinical Research is responsible for developing high-quality regulatory documents that support global clinical development of Tilray’s investigational drug products as well as publications that support dissemination of scientific and clinical data to healthcare professionals. The Technical Writer, Clinical Research is also a key member of cross-functional clinical research study team.
Reporting to the Vice President, Global Patient Research & Access, the Technical Writer, Clinical Research will generate Quality Overall Summary (QOS), Chemistry, Manufacturing and Controls (CMC) content, and Investigational Brochures (IB) from source documentation, and provide technical writing support for high quality clinical research submissions. Tracks and maintains up to date filings, including post-approval changes, content templates and/or compliance updates across all clinical research trials. The successful candidate works effectively with cross-functional groups and has excellent writing and communication skills.
Role and Responsibilities
Performs technical writing and editing assignments related to all QOS/CMC/IB/DMF components of clinical research, Investigational New Drug (IND) submissions other technical documents, as well as any other documents determined to be within the scope of the role, within agreed upon timelines.
Works cooperatively with colleagues in relevant functions or departments at the global and site level (e.g., R&D, Process Development, Manufacturing, Supply Chain, Regulatory Affairs, Validation, Quality Control, Quality Assurance) and external organizations to ensure achievement of objectives.
Develops and maintains knowledge and expertise in QOS/CMC documents and associated documents for cannabis-containing drug products.
Organization support and project team participation under Clinical Research direction, including information gathering, progress reports and presentations.
Proactively seeks input, feedback and assessment from key stakeholders to drive business improvements.
Leads processes to improve and implement good documentation practices for process and analytical development documents
Leads cross-functional team-level and management-level document reviews; Manages comments, supports the operation of the review process and creates updated drafts for next phase review.
Develops and manages document-specific timelines to ensure on-time deliverables that support corporate goals
Critically reviews documents for consistency and quality.
Serves as the functional area representative on clinical study teams and advises teams on content and format requirements for documents.
Promotes standardization of document process within organization.
Adheres to company Style Guide, templates, and SOPs for document development.
Works with cross-functional teams to ensure production of high-quality written documents.
Use experience in Process Development to identify technical inconsistencies and participate in resolution.
Maintains subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines.
Perform other related duties and assignments as required.
BS or MS in scientific discipline such as chemistry, biochemistry, chemical or biochemical engineering.
Minimum 3 years experience in the Pharmaceutical Industry, or similar regulatory or clincial research environment.
Minimum 2 years experience in writing QOS.CMC components of regulatory submissions together with knowledge of relevant regulatory agency guidance including Health Canada, ICH, FDA, EMA.
Excellent interpersonal, verbal and written communication skills are essential in this collaborative team environment.
Excellent attention to detail, multitasking, prioritization, and flexibility.
Excellent writing skills coupled with ability to edit complex material to ensure accuracy, clarity, and effectiveness.
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
Thorough knowledge and understanding of global clinical research requirements and expectations relating to QOS/CMC/IB content of regulatory submissions throughout the life-cycle of drug development.
Strong understanding of science and engineering concepts related to Pharmaceutical Development.
Author responses to agency questions within the required timeline.
Ability to think critically, and demonstrated troubleshooting and problem solving skills.
Self-motivated and willing to accept temporary responsibilities outside of initial job description.
Experience in preparation of a variety of technical documents such as SOPs, QOS’ and IBs.
Experience in cannabis research/science an asset.
Excellent organization skills and flexible attitude with respect to work assignments and new learning.
Strong word processing and Microsoft Office Suite skills; advanced skills in Microsoft Word and proficiency in Excel and PowerPoint.
Ability to influence achievement of strategic objectives.
Evaluates the facts in order to make the best decisions.
Ensures proactive management of the company’s response and commitment in dealings with authorities.
Makes realistic and appropriate decisions within a regulatory context.
Communication and Interpersonal Skills:
Ability to build relationships of trust and demonstrate professional ethics.
Communicates clearly and effectively within all levels of the organization and with external resources.
Acts as liaison between authorities as well as outside partners and clients in order to provide adequate regulatory direction to in-house resources.
Develops effective working relationships.
Drafts reports within prescribed time lines in accordance with regulations.
Ability to implement solutions in response to regulatory changes.
Adopts an innovative and rigorous approach to problem solving within a clinical research context.
Assesses the urgency of situations
Working Conditions and Environment:
Normal business environment.
Occasional travel for meetings, training.
Tilray welcomes applications from all qualified individuals and is committed to employment equity and diversity in the workplace.
Accommodations are available for applicants with disabilities throughout the recruitment process. If you require accommodations for interviews or other meetings, please advise when submitting your application.
Please note that Tilray does not authorize, engage, or sponsor any consultants, agencies or organizations that seek certain personal or financial information from you (e.g. passwords, login ids, credit card information). Tilray does not charge any application, processing or onboarding fee at any stage of the recruitment or hiring process.
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