Technical Writer - Toronto, Ontario
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?
Ready to apply your talents to make a positive difference in the lives of patients across the country?
Reporting to the Senior Manager, Regulatory Affairs, the Technical Writer, Regulatory will generate the Drug Master File (DMF) content from source documentation and provide technical writing support for high quality regulatory submissions and a wide range of supporting documentation for product quality. Tracks and maintains up to date filings, including post-approval changes, core DMFs, content templates and/or compliance updates across all global franchises. The successful candidate works effectively with cross-functional groups and has excellent writing and communication skills.
Roles and responsibilities
- Performs technical writing and editing assignments related to all DMF components of regulatory submissions other technical documents including content templates, 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 DMFs and associated documents for cannabis-containing drug products.
- Organization support and project team participation under Global Regulatory direction, including strategy meetings, information gathering, progress reports and presentations.
- Proactively seeks input, feedback and assessment from key stakeholders to drive business improvements.
- Manages comments, supports the operation of the review process and creates updated drafts for next phase review.
- Leads processes to improve and implement good documentation practices for process and analytical development documents
- Critically reviews documents for consistency and quality.
- 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.
- Perform other related duties and assignments as required.
- BS or MS in scientific discipline such as chemistry, biochemistry, chemical or biochemical engineering.
- Must be able to fluently speak and write in English.
- Minimum 3 year experience in the Pharmaceutical Industry, or similar regulatory environment.
- At least 2 years' experience in writing DMF components of regulatory submissions together with knowledge of relevant regulatory agency guidance including ICH, FDA, EMA.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
- Thorough knowledge and understanding of global requirements and expectations relating to DMF content of regulatory submissions throughout the lifecycle 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 and DMFs.
- Ability to influence achievement of strategic objectives.
- Behavioral Indicators:
- 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.
- Behavioral Indicators:
- 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.
- Problem Solving:
- Ability to implement solutions in response to regulatory changes.
- Behavioral Indicators:
- Adopts an innovative and rigorous approach to problem solving within a regulatory context.
- Assesses the urgency of situations.
- Working Conditions and Environment:
- Normal business environment.
- Occasional travel for meetings, training.