Associate Director

Date: Feb 28, 2021

Location: NJ, US

Company: ArisGlobal

By empowering life sciences organizations to deliver breakthroughs faster, ArisGlobal has become an industry leader, currently providing our technology solutions to 40 of the top 50 Biopharmaceutical companies, 4 of the top 5 pharma organizations and 9 government health authorities, including the FDA, Health Canada and the NMPA. Our end-to-end drug development technology platform, LifeSphere®, helps hundreds of pharmacovigilance teams around the world save time and effort, ensure future-proof compliance, and unlock deep insights from safety data.  ArisGlobal has formed a solution that ensures game changing efficiency, compliance, speed, and safety, with accuracy and precision. Is it any wonder we are seeking the best blend of experience, knowledge, talent, and ambition?

 

Senior Director/Associate Director, Product Management - Level TBD

 

ArisGlobal is seeking an Associate Director, Product Management professional to join the Regulatory Affairs Product Management Team as part of our Global Regulatory Domain. If you have the creativity to translate regulatory affairs transformational elements to product ideas, love working in unchartered territory and thrive on boundarylessness, we want to talk to you.

 

ArisGlobal’s LifeSphere Regulatory suite of products is undergoing major investments and we are looking for senior product management professionals that can contribute to one or more of following focus areas:

  • Content Management (including Document Management System, Publishing)
  • Label Management (including Structured Component Authoring)
  • Regulatory Automation using AI technologies
  • User Experience / Usability Design
  • Regulatory Analytics
  • RIMS for Medical Devices
  • Compliance to standards like eCTD, IDMP, xEVMPD, UDI (GUDID, EUDAMED), SPL, etc.

 

To be Successful in this Position:

You understand the company’s primary mission of expanding revenue and revenue opportunities, in line with overall company strategy. You successfully merge customer facing and industry/agency thought leadership experience with ArisGlobal’s product offerings in Regulatory domain. You have an established track record in building business cases for new concepts, including high level revenue targets, cost estimations and product positioning/packaging/pricing, working with senior management and executives to get approval for business cases, engaging with customers, prospects and ArisGlobal’s identified industry partners to build product and/or solution strategy and elicit business requirements for regulatory affairs software products and/or services for Pharmaceutical, Biotechnology and/or Medical Devices domain. 

 

In this Role You Will:

  • Support the company’s ability to conceive and build market leading software products for the regulatory domain.
  • Ensuring that industry trends, needs and business requirements are monitored, documented and communicated to internal teams like other product management peers and team members in engineering, services and marketing.
  • Equip teams to design, build, sell and implement products in line with the company’s overall strategy.

 

Essential Duties and Responsibilities

  • Establish and implement the vision for new areas of investment in the LifeSphere Regulatory suite of products, by translating the strategic plan into required product strategy and roadmap, working to articulate value and ROI to enable appropriate prioritization of new features and backlog.
  • Maintain an in-depth understanding of requirements of regulatory affairs business needs and software solutions like Regulatory Information Management Systems (RIMS), xEVMPD or IDMP systems, eCTD Publishing systems or regulatory document management systems (DMS) while working within industry.
  • Provide input into and drive the concept for proposals and business requirements for ArisGlobal’s Regulatory domain software products; particularly, working with customers, prospects, and industry partners, especially w/in a given geography/country, to ideate, gather, validate and document business needs and requirements by presenting software concept proposals via workshops.
  • Working with the peer product management team members and the ArisGlobal engineering team based in India to document and review detailed functional requirements, ensuring that business knowledge of the requirements are transferred to the team.
  • Practice other Product Management key activities like competitive analysis, pricing model, product packaging decisions, competitive release scoping, user experience designing & wireframing in collaboration with UX Design team, release scoping and backlog grooming in collaboration with peer product managers/business analysts.
  • Serve as the Product SME/Champion with Client Partners and Customer Success managers in ensuring product adoption success, customer satisfaction and increased up/cross sell at top 50 pharma/device customer accounts by regularly connecting with customer’s leadership team to communicate about product strategy, vision and roadmap; doing so by championing usage of product features in line with industry standard practices with end users at assigned customers; and by ensuring that their voice and sentiment is communicated back to product management, engineering and rest of the organization.
  • Contribute in the Regulatory Industry Standard Practices (ISP) Forum initiatives including reviewing customer facing materials like business processes, standard configuration content, etc. and conducting web based and in person working groups with ISP members (customers and industry partners) to get required business inputs.
  • Maintain familiarity with relevant regulatory issues, compliance, and guidance which may impact the solutions being presented.
  • Familiarize sales, pre-sales, services, marketing and customer support teams on a regular basis regarding new product features via internal product demonstrations and share knowledge on market trends and competitive assessment.
  • Share product and domain knowledge with Pre-Sales / Solution Consulting teams to enable them to respond to RFPs, and help them prepare for bid-defence meetings, and if needed for big deals, also be present to engage with business leaders as a product champion who understands customer’s language.

 

Requirements: Education and Experience

  • Bachelor’s degree in Information Systems or Life Sciences / Pharma, Mgmt. degree preferred
  • Minimum 8 years of relevant experience (recall: *designation i.e. Director, Associate Director Product Management or Senior Product Manager will match experience)
  • Min of 3 years in Life Sciences, SaaS, Pharma, Biotech or Medical Device in Regulatory, i.e.:
  • Regulatory information management, document management, label management, dossier planning and preparations, publishing and submissions, change management (especially US & EU procedures), CMC, label and artwork management, regulatory/manufacturing integrations, etc.  

 

Soft Skills

This individual is a specialist role that requires self-motivation, the ability to communicate at all levels of an organization and an excellent understanding of both industry and software.

  • Work well with others and have a knack for understanding needs and problems.
  • Proven ability to influence cross-functional teams at all levels of leadership.
  • Excellent communication skills both written and verbal.
  • Visual way of presenting nebulous ideas and complex concepts in a simplified manner.
  • Effective time management & multi-tasking skills.
  • Ability to analyze and relate customer issues/requirements to ArisGlobal software solutions.
  • Self-managed, self-starter, able to work in rapidly changing environment.
  • High energy, detail oriented and creative individual.
  • Ability to work both independently and cohesively in a team environment.

 

Working Conditions

  • TBD w/ manager; current remote
  • Approximately 20% - 40% travel (dependent on candidate location)

 

Perks & Benefits

ArisGlobal proudly offers an Impressive Package of Compensation and Benefits. The following benefits are available for fulltime employees in the United States. Other benefits may apply for employees in other countries. Some of these include:

  • 401(k) ADP: 3% match, first pay period
  • Cigna health, dental, vision: day one
  • Paid maternity + paternity leave
  • Employee referral program – cash bonus’
  • PTO + Holidays + extra days (20+ days year-one)
  • FSA + HSA's, Non-med insurances + Teledoc + pet insurance + theft protection + more…

 

ArisGlobal is headquartered in Miami, Florida, with offices located in more than 9 countries around the world. Please check out our website/LinkedIn to find out more information about the organization and other available positions.

 

*ArisGlobal is an Equal Employment Opportunity Employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, age, marital status, national origin, protected veteran status, disability, or any other legally protected class.