Shifa Javed

I have recently graduated (Dec 2024) with the RA certificate, I have a PhD in Oncology (2018) and three years (2022) industry experience where I did both lab work and regularly reviewed newly published literature and research to enhance scientific knowledge, addressing challenges in analyzing multiple articles, grants, proposals, and SOPs.

During my certification I successfully completed the internship at Health Canada (2024) where I was able to assess and code (IMDRF coding system) over 900 reports of medical device incidents to support the delivery of a national post-market surveillance program for medical devices sold in Canada.

With an assignment with Baxter international for about six months I was able to get exposure to regulatory documents like CER and CEP. I conducted scientific literature searches, collecting over 300 research articles from appropriate databases, and extracted relevant information from identified articles using EndNote (e.g., PubMed and other search engines) for relevant documents.

Skilled medical writer with a combined 6 years of experiences in the academic, biotech and medical device space across diverse therapeutic areas. Adept at collaborating with internal and external stakeholders to resolve regulatory enquiries, optimize operational processes, and contribute to the development of SOPs and reports. Proven expertise in evaluating medical device problems incident reporting, drafting regulatory documents, and ensuring compliance with ISO standards, Good Clinical Practices (GCP), and EU Medical Device Regulation (MDR)

During my study period, I gained comprehensive insights into Canadian and global drug and healthcare legislation, regulations, and guidelines, ensuring compliance and alignment with industry standards. I developed a strong understanding of how regulatory processes and manufacturing practices influence product quality and safety. My experience includes preparing thorough and accurate regulatory submissions, including supplemental documentation for the Therapeutic Product Program.

I also applied principles of Good Manufacturing Practices (GMP) to maintain high-quality standards and regulatory compliance. Additionally, I honed my skills in negotiating and managing the regulatory review process, fostering effective communication with regulatory bodies to streamline approvals.