Job
Description
Software Development Lead Roles & Responsibilities Lead complex software projects from conception to deployment. Manage software delivery scope, risk, and timeline. Rapid prototyping expertise, translating concepts into working code quickly. Provide technical guidance and mentorship to junior developers. Contribute to both front-end and back-end development using cloud technology. Develop innovative solutions using Generative AI technologies. Conduct code reviews to ensure quality and adherence to best practices. Create and maintain software documentation on architecture, design, deployment, disaster recovery, and operations. Stay updated with industry trends and advancements. Collaborate with product teams, business teams, and stakeholders. Design, develop, implement, and maintain applications with configurations, custom reports, interfaces, and enhancements. Analyze and translate technical requirements into software architecture specifications. Implement unit tests, integration tests, and other testing strategies for software quality assurance. Integrate applications with external systems for seamless data flow and functionality. Provide ongoing support and maintenance, ensuring smooth system operations. Improve reliability, scalability, and performance of applications. Develop and maintain monitoring tools and dashboards for system health tracking. Respond to incidents, conducting root cause analysis and implementing preventive measures. Implement security measures to protect against unauthorized access and cybersecurity threats. Basic Qualifications Doctorate degree OR Master's degree with 4-6 years of Computer Science, IT, or related field experience OR Bachelor's degree with 6-8 years of Computer Science, IT, or related field experience OR Diploma with 10-12 years of Computer Science, IT, or related field experience Must-Have Skills Strong business acumen with deep understanding of pharma regulations and compliance. Expert knowledge of submission publishing systems (Lorenz's docuBridge, Disclose from Citeline). Familiarity with ClinicalTrials.gov and EudraCT. Experience with Regulatory Veeva Vault. Proven success in managing technology initiatives, driving innovation and talent development. Exceptional collaboration and communication skills, with ability to manage multiple priorities in a fast-paced environment. Expertise in technology standard practices (Scaled Agile (SAFe), ITIL). Strong knowledge of information systems and network technologies. Good-to-Have Skills Extensive experience with eCTD specifications and highly regulated (GxP) systems. Leadership experience in pharmaceutical or technology organizations. Strong understanding of software development lifecycle for GxP Systems. Experience in Scaled Agile Framework (SAFe) adoption. Analytical and critical-thinking skills for effective decision-making. Ability to manage projects in dynamic, fast-paced environments. Established business partnerships and IS governance expertise. Broad knowledge of key IS domains and layers. Professional Certifications (Preferred) ITIL Certification (preferred). Scaled Agile Framework (SAFe) for Teams (preferred). Veeva Vault platform Certification (preferred). Soft Skills Excellent analytical and problem-solving abilities. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented focus on achieving collective goals. Strong presentation and public speaking skills.
