Verified Job
Content Writer
Regulatory Data and Content Professional (Senior Medical Writer) # 26-1*415
Content Writer
#798631
Remote / WFH
US Tech Solutions
Job Description
Duration: 12 months (possible extension)
Work Location: This is an onsite role located within the Client Mississauga campus. Selected candidate is required to work at the Client Mississauga Campus minimum of three (3) times every week.
Description:
• A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
• The Pharma Development Regulatory (PDR) is a flexible, bold, and distinctive regulatory organization. We make decisions quickly and strategically as the environment & landscape evolves.
We innovate. Within the PDR Data and Content Chapter, we are responsible for end-to-end data interpretation, generation and execution of content strategy, insight generation to guide submission strategy, and leadership of submission planning and management for clinical projects in the Client portfolio in order to develop and maintain Client product permits/licenses to meet the needs of our patients.
• We understand how data and information contribute to the strategy and quality of submissions, and thus, deliver high-quality submissions to global Health Authorities for products throughout their development lifecycle to facilitate reviews and approvals.
We ensure audit and inspection readiness and representation. Additionally as a member of PDR, individuals understand how data and information contribute to the quality of our submissions
• As a member of this Chapter, you will drive and manage data interpretation and content, including medical writing, from initiation to approval, developing data and content standards, driving and articulating key messages, content creation, strategic reuse of content, and implementing automation and next-generation systems and tools.
The Opportunity:
• Leads a team of Content Strategists and/or cross-functional teams in development and execution of the content strategy for submission to global regulatory authorities in accordance with applicable regulatory guidelines/Client standards/SOPs. Regulatory content may include the Clinical Dossier and/or Suite of Safety reports for drugs or medical devices
• Plans content and creates timelines for the production and review of documents, ensuring alignment with overall project timelines where appropriate.
• Reviews documents for organization, clarity, scientific standards, and consistency of content, data, and messaging.
• Resolves issues with cross-functional contributors. Ensures compliance with regulatory requirements and internal processes
• Is a key strategic participant in functional and cross functional teams and actively contributes to best practices and continuous improvement initiatives and projects
Work Location: This is an onsite role located within the Client Mississauga campus. Selected candidate is required to work at the Client Mississauga Campus minimum of three (3) times every week.
Description:
• A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.
Creating a world where we all have more time with the people we love.
• The Pharma Development Regulatory (PDR) is a flexible, bold, and distinctive regulatory organization. We make decisions quickly and strategically as the environment & landscape evolves.
We innovate. Within the PDR Data and Content Chapter, we are responsible for end-to-end data interpretation, generation and execution of content strategy, insight generation to guide submission strategy, and leadership of submission planning and management for clinical projects in the Client portfolio in order to develop and maintain Client product permits/licenses to meet the needs of our patients.
• We understand how data and information contribute to the strategy and quality of submissions, and thus, deliver high-quality submissions to global Health Authorities for products throughout their development lifecycle to facilitate reviews and approvals.
We ensure audit and inspection readiness and representation. Additionally as a member of PDR, individuals understand how data and information contribute to the quality of our submissions
• As a member of this Chapter, you will drive and manage data interpretation and content, including medical writing, from initiation to approval, developing data and content standards, driving and articulating key messages, content creation, strategic reuse of content, and implementing automation and next-generation systems and tools.
The Opportunity:
• Leads a team of Content Strategists and/or cross-functional teams in development and execution of the content strategy for submission to global regulatory authorities in accordance with applicable regulatory guidelines/Client standards/SOPs. Regulatory content may include the Clinical Dossier and/or Suite of Safety reports for drugs or medical devices
• Plans content and creates timelines for the production and review of documents, ensuring alignment with overall project timelines where appropriate.
• Reviews documents for organization, clarity, scientific standards, and consistency of content, data, and messaging.
• Resolves issues with cross-functional contributors. Ensures compliance with regulatory requirements and internal processes
• Is a key strategic participant in functional and cross functional teams and actively contributes to best practices and continuous improvement initiatives and projects
