Strategic Designer, Senior Manager

Strategic Designer, Senior Manager

Direct Hire

Location: McLean, Virginia

Will consider remote

The ideal candidate will have:

  • Strategic Design
  • Figma (preferred), Sketch, Invision or similar UX/UI applications
  • Research
  • Experience with Innovation or Start-up environments
  • Proven ability to collaborate in cross-functional teams in Agile environments

You will:

  • Discover and incubate new startup opportunities for the line of business
  • Own the charge to re-imagine business process and build products using emerging technology, incorporating insights into product, market, and technology trends
  • Open up the boundaries for innovation, technology, and processes to improve the way we think and work within the company

Your Impact:

As an experienced, multidisciplinary digital designer, you will contribute to broader team objectives throughout the design lifecycle from conceptualization, iterative prototyping and MVP design, go to market strategies, and business case development. In this role, you will:

Provide Design Services:

  • Work on concepts that span market and competitive insights, emerging trends and themes, customer journeys, and needs and personas synthesizing and defining the problem space
  • Develop digital concepts and product strategies bringing prior experience in areas such as UX design, visual, branding, content strategy and digital marketing in addition to strategic design
  • Develop storyboards, low and high-fidelity wireframes and visualizations to pitch ideas and show how they will transform how our customers work
  • Engage in a rapid, iterative approach that enables fast experimentation, learning and co-creation with customers

Conduct Research:

  • Research and present digital exemplars and lead ideation workshops that draw on multiple subject areas to build a concept vision through measurable insights incorporating experience with research methods
  • Determine qualitative approaches, techniques, and tools, and define target population to approaches to validate hypotheses and test product usability in market
  • Lead and/or work with 3rd parties in the execution of primary research to uncover insights from customer behaviors, needs (known and unmet), and receptivity to new concepts.
  • Summarize research findings and insights for executive reviews.

Champion Human Centered Design:

  • Channel the voice of the customer ensuring that the business solution is thoughtfully designed to support their needs and advocate incorporating research findings into design prototypes, MVPs, etc.

Qualifications: read more

TMF Specialist

Title: TMF Specialist
Regulatory Documentation
Term: Anticipated 1 year, potential to extend
Location: Woodcliff Lake, NJ
On-site or Remote position – up to 40 hrs week

The ideal candidate will have:

Basic knowledge of CFR, GCP & ICH Guidelines
2 plus years Pharma experience (includes CRO / Vendor experience)
Knowledge and understanding of DIA TMF Reference model

The Role:

  • Perform daily Trial Master File management activities such as Review, Processing, Filing of Clinical Trial Master File documents, to ensure the TMF is Inspection Ready.
  • Conduct Quality Control reviews of TMF Documents. Coordinate with eTMF vendor for TMF set-up and processing of TMF documents and conduct eTMF query resolution.
  • Assist in the archiving of TMF documents; this may include shipping, retrieval, and tracking of documents approved for archiving to off-site storage; Maintain electronic logs which contain the location of study documents.
  • Development/Contribution toward user manuals / Best Practice guides
  • Must have strong document management skills, including experience with review of Regulatory Documents, be detail oriented, organized, quality driven and able to work in a team environment under tight deadlines.
  • Knowledge/understanding of TMF requirements and technologies to support document collection and archiving; eTMF experience preferred.
  • eTMF/TMF Process and system training
  • eTMF Implementation experience
  • Ability to think outside the box
  • Hands on Inspection experience (FDA, MHRA, etc)
  • Internal audit preparation
  • Support integration of partnered or clinical information including transfer of TMFs in compliance with applicable regulations and best practice
  • Proactively stay current with best practices and recommends application across business groups to improve TMF operations
  • Assist with TMF process education
  • Assist CRO eTMF configuration
  • Assist and deliver key KPI reports to study team, manage expectations, and track on-going KPI across all study team by partnering with clinical operations leads
  • read more