Associate Director

Date: Nov 28, 2020

Location: NJ, US

Company: ArisGlobal

Director / Associate Director / Senior Product Manager – Regulatory Affairs Domain, US/ EU/ Remote

ArisGlobal is a dynamic and growing global software company dedicated to serving the life sciences (pharmaceutical, biotechnology and medical device) companies in the management of their clinical trials, drug safety and regulatory information. Our global team – located in major corners of the world – includes some of the industry’s leading authorities, subject matter experts and experienced professionals in their respective areas of life sciences. All are focused on advancing our innovative and market-proven solutions and services.

"Are you are looking for a career where your involvement can make a difference?" We are growing fast and always looking for people with the best blend of experience, knowledge, talent and ambition. If you are committed to making a difference and have the skills and experience to make things happen then JOIN US.

 

Overview

With multiple openings available across the Americas (Miami, Florida; Bridgewater, New Jersey & remote roles available), and Europe (Germany, Hungary & remote roles available), ArisGlobal is seeking experienced Product Management professionals to join the Regulatory Affairs Product Management team as part of our global Regulatory domain. The designation i.e. Director, Associate Director Product Management or Senior Product Manager will be determined after evaluating the skills and experience of those selected.

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, the ideal candidate will understand the company’s primary mission of expanding revenue and revenue opportunities, in line with overall company strategy. To do so, this individual will successfully merge customer facing and industry/agency thought leadership experience with ArisGlobal’s product offerings in Regulatory domain. The ideal candidate will 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.  Further, the candidate will support the company’s ability to conceive and build market leading software products for the regulatory domain, by 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 to equip them 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, Bio-Tech 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

The SME 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 svoftware.

  • Must work well with others in person or virtual and have a knack for understanding needs and problems.
  • Proven ability to influence cross-functional teams at all levels of leadership is a must.
  • Excellent communication skills both written and verbal required. Visual way of presenting nebulous ideas and complex concepts in a simple way is considered as a key aspect of communication in this role.
  • Effective time management & multi-tasking skills.
  • Ability to analyse 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)

 

Benefits

ArisGlobal proudly offers an Impressive Package of Compensation and Benefits. In addition to competitive salary compensation and paid time off, eligible costs by reducing taxable income. Income protection and wealth accumulation benefits help our employees reach their long-term financial goals.

As a full-time employee of ArisGlobal, you will have the option to participate in various benefit programs as you meet the respective eligibility criteria. Some of the more significant ArisGlobal benefits and programs include:

  • Eligible to participate in the ArisGlobal 401(k) program administered by ADP: 1st pay-period
  • 401(k) - First 3% match capped at max $4,000 EMR annually
  • Cigna Insurance for health, vision, and dental: starts day 1!
  • Paid Maternity/Paternity Leave
  • Employee referral programs - $1000+
  • Paid time off, holidays, and floating holidays (20 + days)
  • Flexible spending accounts + HSA's
  • Non-medical insurances + Teledoc (pet insurance optional, included!!)


*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