SPE-Reg Affairs-Med Writing

Job Summary

This hybrid role of Senior Professional Regulatory Affairs and Medical Writing focuses on preparing high quality regulatory documents and product submissions that comply with global life sciences standards and internal policies while supporting research and development teams. The candidate will apply regulatory domain expertise to transform complex scientific and business information into clear documentation that enables timely approvals supports patient safety and advances the company mission

Responsibilities

• Collaborate with regulatory affairs and research and development teams to prepare comprehensive regulatory reports that clearly communicate product safety efficacy and quality data for timely submission to global authorities.
• Develop structured regulatory documentation by transforming complex scientific findings and business requirements into accurate concise and compliant narratives that support product registrations and lifecycle management.
• Coordinate regulatory product specialist activities by aligning documentation content with evolving product strategies indications and risk profiles to ensure consistent messaging across all submissions.
• Conduct detailed regulatory domain analysis to interpret guidelines policies and standards and translate them into practical documentation plans and templates that streamline reporting activities.
• Perform regulatory business analysis by mapping business processes timelines and data dependencies to create clear documentation workflows that reduce rework and support audit readiness.
• Implement regulatory and standards compliance practices throughout medical writing tasks by applying relevant laws industry standards and internal procedures to minimize compliance risks.
• Engage with life sciences regulatory stakeholders to gather source information verify data integrity and resolve content gaps ensuring that all written deliverables reflect accurate and current scientific evidence.
• Prepare high quality clinical and nonclinical summaries risk management sections and justification narratives that demonstrate product benefit risk profiles and support regulatory decision making.
• Maintain robust documentation control and version tracking for regulatory submissions by organizing files references and supporting data in structured repositories that enable efficient review and inspection.
• Support hybrid work model collaboration by using digital tools and secure platforms to manage document reviews track comments and maintain transparency among cross functional contributors.
• Contribute to continuous improvement of regulatory business process services by recommending enhancements to templates checklists and workflows that increase efficiency and consistency in medical writing output.
• Ensure day shift availability for cross functional meetings and real time collaboration enabling responsive support to regulatory teams without requiring travel commitments.
• Advance company purpose and societal impact by producing clear and trustworthy regulatory documentation that facilitates safe and effective healthcare solutions reaching patients and communities.

Qualifications

• Apply foundational experience in regulatory reporting to design and deliver submission ready documents that meet authority expectations and internal quality benchmarks.
• Utilize regulatory product specialist knowledge to align written content with product claims target markets and risk management strategies in a descriptive and well structured manner.
• Leverage strong regulatory domain knowledge to interpret complex guidance documents and convert them into practical writing approaches that reduce ambiguity and enhance compliance.
• Use regulatory business analyst skills to assess information flows data sources and stakeholder needs producing documentation that supports informed regulatory and business decisions.
• Demonstrate expertise in regulatory and standards compliance by consistently integrating applicable frameworks into medical writing activities thereby reducing rejection rates and queries.
• Apply life sciences regulatory experience to ensure that documentation reflects industry best practices scientific rigor and ethical considerations in research communication.
• Draw on background in regulatory business process services to support streamlined document preparation review and approval cycles that fit organizational governance models.
• Employ regulatory affairs knowledge to create submission packages that address authority expectations cover all required modules and respond effectively to potential questions.
• Use research and development exposure to understand study designs endpoints and methodologies enabling accurate description of evidence in regulatory documents.
• Demonstrate fluent English language skills native level read write speak to produce precise clear and easily understood regulatory narratives and correspondence.
• Adapt experience level between one and four years to handle progressively complex documentation tasks while remaining open to mentoring feedback and structured skill development.
• Show commitment to hybrid work practices by effectively managing time communication and documentation tasks across onsite and remote settings while maintaining confidentiality and data security.

Certifications Required

Regulatory Affairs Certification RAC or equivalent credential in life sciences regulatory or medical writing

Over Cognizant  
Cognizant (NASDAQ: CTSH) is een bouwer van AI-oplossingen en een leverancier van technologiediensten. Wij slaan de brug tussen AI-investeringen en ondernemingswaarde door het bouwen van full-stack AI-oplossingen voor onze klanten. Onze diepgaande kennis van sectoren, processen en engineering stelt ons in staat om de unieke context van een organisatie te verankeren in technologische systemen. Deze systemen versterken het menselijk potentieel, realiseren tastbare resultaten en geven wereldwijde ondernemingen een voorsprong in een snel veranderende wereld. Ontdek hoe op cognizant.ai of @cognizant.

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