Job description
Join New Era Technology, where _People First_ is at the heart of everything we do. With a global team of over 4,500 professionals, we’re committed to creating a workplace where everyone feels valued, empowered, and inspired to grow. Our mission is to securely connect people, places, and information with end-to-end technology solutions at scale.
At New Era, you’ll join a team-oriented culture that prioritizes your personal and professional development. Work alongside industry-certified experts, access continuous training, and enjoy competitive benefits. Driven by values like Community, Integrity, Agility, and Commitment, we nurture our people to deliver exceptional customer service.
If you want to make an impact in a supportive, growth-oriented environment, New Era is the place for you. Apply today and help us shape the future of work—together.
Summary
We are seeking a visionary and analytically rigorous Senior Business Strategist to lead long-range planning across a portfolio of pharmaceutical innovations. This role is ideal for a seasoned strategist with a strong background in pharma and experience with IT or R&D, someone who thrives at the intersection of business foresight, regulatory intelligence, and emerging technology.
Key Responsibilities
- Strategic Roadmapping & Scenario Planning
- Refine and evolve a multi-year product roadmap that spans over 100 drug candidates, identifying which 7 - 8 may benefit from connected or digital solutions.
- Map and continuously track 8+ strategic vectors including technology, regulatory shifts, competitive moves, pipeline maturity, privacy laws, and patient delivery models (e.g., shift from injectables to orals).
- Develop predictive scenarios that anticipate how FDA guidance, political administrations, and global privacy regulations may evolve—especially in areas like AI, cybersecurity, and digital therapeutics.
- Competitive & Regulatory Intelligence
- Act as a “student of the industry,” continuously monitoring competitors’ strategic moves, FDA trends (e.g., 21 CFR Part 11, 870), and global privacy frameworks.
- Interpret FDA behavior based on historical precedent and emerging signals to avoid surprises (e.g., security patching expectations).
- Maintain fluency in the latest guidance on medical device regulations and audit response strategies.
- Data-Driven Foresight & Deliverables
- Lead the collection and synthesis of internal and external data, including vendor-sourced intelligence, to inform strategic decisions.
- Deliver high-impact visualizations such as Gantt charts, milestone maps, and probability-weighted scenarios.
- Apply a “fail-fast” mindset to predictions, validate assumptions, iterate quickly, and adjust direction based on new evidence.
- Stakeholder Engagement & Influence
- Partner closely with the client manager to define workstreams and priorities, while operating independently to drive execution.
- Synthesize complex data into compelling narratives that influence investment decisions and strategic direction.
- Actively seek out internal and external experts, integrating their insights into cohesive strategies.
Qualifications:
- 10+ years in strategic planning, management consulting, or pharma innovation roles.
- Strong background in pharma IT, R&D, or regulatory affairs; experience with FDA validation and audit response is a plus.
- Deep understanding of long-term IT planning (5–10 years), including architecture, digital health, and connected devices.
- Familiarity with 21 CFR Part 11, Part 870, and global privacy regulations (e.g., GDPR, HIPAA).
- Entrepreneurial mindset with a track record of anticipating industry trends, ideally someone who speaks at conferences or has led innovation in biotech or medtech startups.
- Exceptional communication, business acumen, and storytelling skills to influence senior stakeholders.
Attributes for Success:
- Strategic thinker with a bias for action.
- Former IT Architect or R&D Manager in Pharma or MedTech.
- Pharma Quality or Regulatory Expert with strategic planning experience.
- Strong collaborator who integrates expert input into cohesive strategies. Industry speaker or thought leader with a futurist mindset a plus.
- Significant FDA Quality experience.
- Adept at balancing big-picture vision with detailed execution planning.
- Comfortable operating independently in ambiguous environments.
Below is the pay range of this position for considered candidates based on qualifications and experience.
Pay Range
$90—$93 USD
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