Duration: 12 months (possible extension)

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 Partnering with key stakeholders, working on the molecule portfolio, or continuing to key initiatives that shape our technical, business and healthcare environments. Maintains up-to-date knowledge of key regulatory, scientific, and medical topics relevant to drug development and disease/therapeutic areas May act as a mentor to new or less experienced Content Strategists Who you are: Degree in Life Sciences or equivalent with 5 years of relevant experience in the pharmaceutical/biotechnology industry, demonstrating independent project delivery and leadership. Experience in leading cross-functional teams. Familiar with regional/global drug and device development processes, regulations, and guidelines (e.g., GxP, GCP, ICH, ISO, and MDR/IVDR) and an understanding of GVP and GCP principles, including data integrity. Demonstrated expertise in clinical, safety and/or device regulatory documentation throughout the product lifecycle, from early development through post-marketing activities. Ability to independently analyze and synthesize data and non-clinical and clinical concepts from a broad range of disciplines. Proven ability to drive outcomes in global filings (strongly preferred) and other regulatory projects by collaborating across diverse, cross-functional teams, leveraging strong communication and interpersonal skills to build trust, foster collaboration, and resolve conflicts in matrixed environments. Excellent administrative and project planning skills, with proficiency in G Suite, Microsoft Office Suite, Adobe Acrobat, and Veeva Vault; detail-oriented, creative thinker with a curiosity to learn and adapt to change, and fluent in English (verbal and written). Mandatory Skills Required - technical/non-technical (Maximum of 4 bullet points): Degree in Life Sciences or equivalent 5 years of relevant experience in the pharmaceutical/biotechnology industry, demonstrating independent project delivery and leadership. Experience in leading cross-functional teams. Familiar with regional/global drug and device development processes, regulations, and guidelines (e.g., GxP, GCP, ICH, ISO, and MDR/IVDR) and an understanding of GVP and GCP principles, including data integrity. Demonstrated expertise in clinical, safety and/or device regulatory documentation Top Primary Goals for New Hire within 60days (Maximum of 3 bullet points): Get onboarded quickly to Client internal document development processes and relevant SOPs Prepare for and kick off the cross-functional authoring process for an assigned project Note: 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.

About US Tech Solutions

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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