Director, Regulatory Implementation

4 weeks ago

Radnor, United States Certara Full time

Overview:
As a Director in our** Regulatory Implementation** role embedded in one of our Software divisions, you belong to the functional team whose work encompasses product delivery, project management, client-specific implementation, and custom handling of the customer experience for strategic accounts. You and your colleagues in Product Management specifically are charged with:
—Targeting R&D investments towards maximum value for customers and business ROI.

—Being accountable for decision-making, problem selection, and business outcomes.

—Guiding product lifecycle from ideation to development to go-to-market to scaled product-market-fit.

—Understanding regulatory customer organization, key players, and strategy in the present and monitoring how they change over time.

—Increasing the industry-visible impact of our organization within the regulatory agencies.

This role is highly cross-functional and, as is typical in a matrix organization, requires a great amount of technical competency, persuasiveness, and ability to lead teams you do not directly manage on behalf of select customers’ desired outcomes. Frequent collaborators with this role include Engineering, DevOps, Consultative Services, Customer Experience, Commercial, and our executive layer, plus third-party software providers and IT project management vendors who serve with us our mutual clients.

**Responsibilities**:
This role requires skillsets, experience, and competencies in:
—**Project Management & Engagement Management**: Planning, Negotiation, Risk Management, Opportunity Expansion

—**Execution & Delivery**: Cross-team Collaboration, Judgement & Decision Making, Responsibility for Outcomes

This role creates impact at the level of a product (or a set of highly interrelated products), drives work for 5-15 people (including other people managers), and sets goals in terms of outcomes and KPIs at the product level.
- While this role (initially) has no direct reports, it contains **broad authority to assemble a cross-functional team** borrowed from our various professional disciplines, to enact inclusion/exclusion criteria upon that team, and to bring to bear direct C-suite level escalations to unblock or reprioritize efforts as needed.
- Also, while this role is not primarily focused on Product Management proper, it is expected to **possess the same competencies as a skilled Product Manager**, and in the interim create requirements for user stories of large value; document client use cases, decisions, and business logic, extending to cross-product and third party integrations; translate leaders' product visions into actionable priorities and often counter-propose compelling priorities, with ability to "sell" ideas to executives, and defend right choices against uncertainty; and frame decisions with clear objectives and context, trading off effectively among internal vs external stakeholder needs and long-term vs short-term goals.

**Primary Duties**:

- Project Management & Engagement Management
- Planning: Prepares proposals, defines scope and sequences, establishes feasibility, controls timelines and budget.
- Negotiation: Makes wise tradeoffs among cost/scope/quality, manages expectations vs. reality, communicates with needed nuance to maintain buy-in.
- Risk Management: Finds and defuses risks while also uncovering new opportunities, triages edge cases and threats to quality, documents decisions for archival, feeds learnings forward as CAPAs.
- Opportunity Expansion: Identify gaps in current solution, unmet present and future needs, as well as needs from adjacent or analogous client-side stakeholders, to expand engagement footprint either through scaling or through development of net new solution branches.
- External Stakeholder Engagement: Proactively builds and manages positive relationships with regulatory agencies; acts as intermediary between the agencies and the delivery team(s); collaborates to confirm customer requirements to ensure deliverables meet expectations.
- Execution & Delivery
- Direct Obligations: Creates project artifacts and documentation related to project deliveries including release notes and other deliverable documentation as well as correspondence document. Creates and delivers other supporting documents as part of the larger relationship and contract including compliance reports for the organization that are required by regulatory agencies.
- Cross-team Collaboration: Manages known opportunities, including conformance with business models and strategic partnerships; ensures successful (quarterly or biannual) releases, with ability to mitigate collision risk from multiple teams working in parallel.
- Judgement & Decision Making: Well versed in constraints & architecture (e.g., data model, tech stack), driving the negotiation of wise tradeoffs.
- Responsibility for Outcomes: Uses instincts, novel data, and industry sense to guide a high quality, wholistic product experience.

Note: This role as

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