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Portfolio Director (REMS)

Remote: 
Full Remote
Contract: 
Experience: 
Senior (5-10 years)
Work from: 
North Carolina (USA), United States

Offer summary

Qualifications:

6+ years in REMS program development, 6+ years project management experience, 5+ years supervising and managing projects, None.

Key responsabilities:

  • Lead drug safety project teams
  • Manage client relationships and scope
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Job description

Job Title: Portfolio Director (REMS)

Job Location: Raleigh, NC, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

Are you a REMS Safety Portfolio professional looking for a new and exciting opportunity?


Envision Pharma Group (EPG) is a leading global partner for the life sciences industry. We drive smarter, faster outcomes for patients in partnership with the worlds largest pharmaceutical and biotech companies. Our clients trust Envision for our market leading technology and artificial intelligence platforms and deep expertise in Strategic Consulting, Medical Communications, Commercialization, HEOR/RWE, Market Access and more.


At our core, are our people, the manufacturers, and patients our solutions impact and benefit across the globe. We drive growth through our innovations as an empowered, accountable, and entrepreneurial team. Our passion makes people healthier and happier.


Being part of a collaborative team means theres no limit to what you can achieve. With us, you can be a part of a growing company you want to work for.


The opportunity


We are looking for a driven and innovative Portfolio Director/Senior Portfolio Director to join our team. In this critical role, you will be a REMS subject matter expert, guiding our delivery teams to ensure successful execution of Shepherd Safety Services projects. Youll lead teams in providing clients with expert drug safety strategies, processes, and systems for REMS and other drug safety initiatives. Additionally, youll play a key role in business growth, contributing to partner engagement, thought leadership, and business development efforts. If you have a passion for delivering outstanding results and driving success, wed love to hear from you!


How will you make an impact at Envision Pharma Group?


Role responsibilities

  • Lead a diverse range of drug safety projects (e.g., REMS strategy, REMS administrator, Shared REMS PMO, RMP/ROW drug safety).
  • Proactively provide insights from safety program understanding and experiences to help project team deliver excellence in project operations, identify and plan for potential project risks, and develop solutions for project delivery and/or client relationship management.
  • Foster and maintain strong collaborative relationships with vendors and partners to support project objectives and ensure smooth execution.
  • Provide insights for strategic frameworks and recommendations to address strategic client challenges.
  • Coach project team on drug safety regulations, guidances, and templates.
  • Support project manager/s develop communication strategies and messaging for external clients.
  • Ensure tracking, reporting and updating of project activities across the life of the project to ensure that the project team consistently meets or exceeds timelines, milestones, and deadlines.
  • Oversee management of program finances, including invoicing schedules, time/effort reporting, and revenue recognition forecasting.
  • Support leadership in setting expectations for vendor/partner engagement, including both day-to-day interactions, problem solving, and difficult conversations.
  • Contribute to vendor/partner agreement review and finalization.
  • Develop tools, templates, and processes to facilitate and/or streamline partner engagement.
  • Coach and mentor direct reports and project teams.
  • Identify new business development opportunities (most likely follow-on sales, or expansion within existing clients).
  • Support Shepherd executive leadership in development of proposals, participate in pitch presentations, and draft project statements of work (SOWs).
  • Support and contribute to the growth and development of our Shepherd Safety Services team.


Do you have what we are looking for?


Skills expertise

  • 6+ years of experience in the development and operation of Risk Evaluation and Mitigation Strategy (REMS) programs (8+ years for Sr. Safety AM)
  • 6+ years project management experience (8+ years for Sr. Safety AM)
  • 5+ years overseeing individual contributors (e.g., line manager, development coach) and managing multiple projects (7+ years for Sr. Safety AM)
  • REMS documentation development (e.g., submission documentation, assessment reports)


#TogetherWeDiscover

We turn vision into reality. Our people are integral to our success and our values reflect the Envision philosophy where our teamwork helps us all grow and our enthusiasm inspires each other.


Our Envisionary culture is a special environment that gives every employee a voice the space to invent and the chance to excel. A place where, every day, people laugh, think, take risks, and are excited about the possibilities the day brings.


Explore your place at Envision. If you have the experience highlighted above, we would love to hear from you!



Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please use the below Lifelancer link to Apply and view similar roles.

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Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Information Technology & Services
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Collaboration
  • Coaching
  • Communication
  • Problem Solving

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