Verified Job
Content Writer
Regulatory Medical Writer
Content Writer
#798633
Remote / WFH
Integrated Resources, Inc
Job Description
Work Location: This is an onsite role. Selected candidates will be required to work at the Mississauga Campus 3 days every week.
Notes from the manager:
Role:
Regulatory Content Strategist, equivalent to Senior Medical Writer. Main expectation:
Candidate must independently own documents end to end from kickoff to approval. Priority experience:
Protocols, PV/safety documents such as DSURs and PBRERs, risk management plans, and medical device documents under MDR/IVDR. Good additional experience:
NDA, MAA, BLA, and other clinical filing documents. Ideal profile:
5–10 years of senior medical writing experience, with repeated end-to-end ownership of relevant document types. Soft skills:
Strong stakeholder management, collaboration, review coordination, and comment adjudication. That’s what makes us Client.
The Pharma Development Regulatory (PDR) is a flexible, Product, 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.
Notes from the manager:
Role:
Regulatory Content Strategist, equivalent to Senior Medical Writer. Main expectation:
Candidate must independently own documents end to end from kickoff to approval. Priority experience:
Protocols, PV/safety documents such as DSURs and PBRERs, risk management plans, and medical device documents under MDR/IVDR. Good additional experience:
NDA, MAA, BLA, and other clinical filing documents. Ideal profile:
5–10 years of senior medical writing experience, with repeated end-to-end ownership of relevant document types. Soft skills:
Strong stakeholder management, collaboration, review coordination, and comment adjudication. That’s what makes us Client.
The Pharma Development Regulatory (PDR) is a flexible, Product, 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.
