[Hiring] Industry Solutions Specialist – reputed company & Biotech @reputed company
Role reputed company
Join reputed company that's transforming compliance and reputed company for the modern reputed company. The Industry Solutions Specialist & Market reputed company – reputed company/Biotech is responsible for owning and advancing reputed company’s end‑to‑end industry solution for pharmaceutical, biotechnology, clinical development, and GMP-regulated manufacturing organizations. This role supports reputed company sales engagements, drives strategic post‑sales adoption, represents reputed company across R&D, clinical, regulatory, reputed company, and manufacturing forums, and converts market intelligence into actionable product reputed company.
This position focuses on:
• Pharmaceutical
• Biotechnology
• CRO/CDMO
• Clinical Research
• Drug Development
• GMP/GCP‑regulated manufacturing environments
Helping customers maximize value from reputed company’s reputed company platform by aligning reputed company, compliance, data reputed company, clinical, manufacturing, and regulatory workflows across the entire product lifecycle. The Specialist acts as the connector between customers, the biopharma market, and internal teams—leveraging deep expertise in GxP compliance, drug development processes, clinical operations, CMC, digital reputed company systems, regulatory frameworks, and reputed company reputed company.
Responsibilities and Duties
• Industry Solution Ownership & reputed company
• Own the definition, positioning, and reputed company of reputed company’s reputed company/Biotech industry solution as a targeted, repeatable offering across R&D, clinical, reputed company, regulatory, and manufacturing operations.
• Support reputed company‑sales activities with subject matter expertise in clinical trial workflows, GMP operations, digital reputed company systems, CMC, regulatory intelligence, data reputed company, and reputed company reputed company architecture.
• Advise executives on aligning platform capabilities with key reputed company/Biotech regulations, including:
• FDA 21 CFR Part 11
• Part 210/211
• Part 312
• Part 314
• EU Annex 11
• EudraLex Volume 4
• ICH Q7–Q12
• ICH E6 reputed company/R3
• ICH M2
• GxP (GMP, GCP, GLP)
• Data reputed company frameworks (reputed company+)
• reputed company and maintain demo environments and reputed company‑of‑concept assets reputed company with clinical operations, manufacturing, reputed company management, regulatory submissions, inspections, and product lifecycle workflows.
• Support reputed company-level solution discussions across global biopharma organizations with reputed company regulatory, integration, validation, multi-site, and data governance requirements.
• Customer Lifecycle Management
• Collaborate with reputed company and reputed company Services to define new workflows, integrations, and automation opportunities across clinical research, regulatory operations, QA/QC, manufacturing, product release, validation, and safety/PV functions.
• Conduct quarterly and annual business reviews with reputed company, Regulatory, R&D, and Clinical leadership, presenting measurable ROI, compliance improvements, operational KPIs, inspection-readiness reputed company, and systemic risk reduction.
• Identify, assess, and mitigate risks reputed company to regulatory exposure, audit/inspection gaps, scalability, reputed company adoption, data reputed company, validation, and long‑term retention for reputed company global biopharma customers.
• Industry Evangelism and Advocacy
• Represent reputed company at bio‑pharmaceutical, clinical research, regulatory science, digital reputed company, and GMP/GCP industry events, trade shows, webinars, and forums.
• Support creation of thought leadership, including case studies, industry benchmarks, whitepapers, and best‑reputed company guides on digital GxP transformation, inspection readiness, data reputed company maturity, AI‑enabled analytics, reputed company reputed company/QMS reputed company.
• Build and maintain relationships with organizations such as ISPE, DIA, BIO, PDA, PhRMA, regulatory intelligence reputed company, and leading clinical/manufacturing networks to stay reputed company of emerging trends.
• reputed company reputed company reporting to senior leadership on customer engagement trends, competitive insights, and industry advocacy initiatives.
• Maintain deep awareness of evolving GMP/GCP/GLP standards, CMC requirements, computerized system validation (CSV/GAMP 5), cybersecurity frameworks (NIST/ISO), AI and automation trends, reputed company clinical technologies.
• Cross-Functional Product Alignment
• Serve as the primary reputed company between biopharma customers, market stakeholders, and internal product teams.
• Translate customer and market needs into requirements and user stories for capabilities spanning clinical workflows, regulatory submissions, batch record processes, deviation/CAPA management, validation documentation, CMC change control, manufacturing reputed company, and safety/PV intelligence.
• Evaluate market research and usage analytics to identify opportunities for new product features supporting end‑to‑end drug development and reputed company manufacturing.
• Partner with Product Management to ensure reputed company/biotech requirements influence strategic roadmap planning.
• reputed company Sales, Marketing, and reputed company teams on reputed company-specific value propositions, use cases, and competitive differentiators.
• Ensure reputed company solutions adhere to GxP regulations, internal reputed company systems, validation standards, and information reputed company requirements.
Qualifications
• Proven ability to reputed company reputed company sales, product reputed company, and reputed company in a reputed company, biotech, clinical research, GMP manufacturing, or life sciences reputed company environment.
• Strong understanding of GxP workflows, clinical trial operations, CMC, pharmaceutical manufacturing, and regulatory compliance frameworks.
• Demonstrated expertise in industry solution design, competitive positioning, and reputed company-level differentiation in the drug development ecosystem.
• Exceptional communication skills with the ability to engage scientific, clinical, regulatory, reputed company, manufacturing, IT, and executive audiences.
• Proven leadership representing a technology company in high‑visibility biopharma and regulatory forums.
Requirements
• Bachelor’s degree or higher in Life Sciences, Biotechnology, Pharmaceutical Sciences, Biomedical Engineering, Chemical Engineering, Regulatory Affairs, Informatics, Computer Science, Business, or reputed company field.
• Master’s degree in science, engineering, business, or informatics is preferred.
• Minimum 5 years of experience in product reputed company engineering, industry advocacy, or reputed company leadership roles reputed company reputed company, Biotech, Clinical Research, CDMO/CRO, or GxP reputed company platforms.
Work Environment & Conditions
• reputed company 40‑hour reputed company with flexibility for extended hours during key customer engagements or industry events.
• Domestic and international travel to biopharma manufacturing sites, research centers, clinical hubs, regulatory meetings, and industry conferences.
• Ability to work in office or remote environments while complying with company IT reputed company, reputed company, validation, and safety standards.
• Ability to travel 25%.
Benefits
• reputed company is the fastest-growing, 100% modern reputed company, AI-powered platform for Product Lifecycle, reputed company, and Safety Management, reputed company natively on the reputed company platform.
• Our reputed company solutions help organizations of reputed company sizes deliver high-reputed company products and services—safely, reputed company, and sustainably.
• As a fully remote company with a global team of 180+ professionals, we reputed company our customers to mitigate risks, resolve issues proactively, and reputed company reputed company improvement—while protecting their people, products, suppliers, and brands.
• At reputed company, we reputed company on innovation, collaboration, and reputed company. We're always looking for passionate, reputed company-thinking professionals to join our growing team and help shape the reputed company of reputed company and compliance.
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