Product Technical Manager - Regulatory Affairs

Date: Dec 31, 2020

Location: KA, IN

Company: ArisGlobal

Role: Associate Diretor
Job Location: Bangalore

About the role:ArisGlobal is looking for seasoned product management professional for its regulatory content management products and integrations, in particular Publishing, Document Management and Structured Component Authoring. This role will be based in Bangalore, will report directly to Product Domain Head based in US, and will be part of a team of product managers, business analysts and SMEs responsible for other regulatory products of ArisGlobal. The designation (Associate Director Product Management or Senior Product Manager) will be determined after evaluating the skills and experience of the candidate.

 

Education & Experience:

Education:

  • Bachelors Degree in Engineering, Masters or Bachelors Degree in software related technology.
  • Graduate in any discipline, with additional qualifications in Healthcare, Medical Sciences, Computer science.

 

Experience:

  • 15+ years’ of relevant (product management) experience.

Skills:

 Technical Skill:

  • Experience in product management, including elicitation of business requirements from internal SMEs and external customers, ideation and grooming of functional requirements,  preparation of requirement documents, UI wireframes, use case scenario and user stories, release scoping and backlog grooming, sprint and release acceptance ownership.  
  • Understanding of entire software development life cycle, especially AGILE
  • Exposure to Regulatory software products used by life sciences industry, especially for Document Management, Publishing and Structured Component Authoring solutions (e.g. Documentum, FirstDocs, ISI Toolbox, Liquent eCTDXpress, Lorenz DocuBrudge, Veeva, i4i Alice4Labeling A4L, etc.)  is essential
  • eCTD & NeeS knowledge is essential.
  • Understanding of Global Regulatory regulations and guidelines, i.e. US and EU regulations, and ICH guidelines is desirable
  • Usage of JIRA, Invision, Visio for product management is a plus
  • Understanding of requirement modelling tools like UML is a plus

 

Non-Technical Skills:

  • Good Communication Skills
  • Interpersonal Skills
  • Business analysis skills

Competencies:

  • Good Communication Skills
  • Technically very strong – ability to learn and contribute to business requirements
  • Updated on industry trends and happenings
  • Customer satisfaction focus

Personal Traits:

  • Positive attitude
  • Team building skills.
  • Analytical and problem solving and Decision-making skills.
  • Initiative and commitment

Roles & Responsibility:

  • Will work very closely with Product Domain Head/s to define strategy for the ArisGlobal’s products in area of regulatory content management like publishing, regulatory DMS and structured component authoring for regulatory documents
  • Will manage a team of PTMs to develop the roadmap, requirements specification, prototypes, POCs, frameworks
  • Work with Development and technology teams to maintain the technology roadmap for the product suite, technology architecture artifacts
  • Will maintain complete requirements backlog for the product
  • Will prepare the proposed product roadmap by prioritizing the backlog based on
  • Regulatory Compliance  
  • Competitive Advantage
  • Contractual or Customer commitment
  • User Experience
  • Prioritized Requirement based on user inputs
  • House Keeping
  • Technology and Architecture
  • Will get the feedback and approval from Product Strategy Board for product roadmap, release scope and timelines
  • Will Work with Product Engineering establish what is possible to be included in the roadmap based on capacity
  • Will develop User Stories Documents completion plan
  • Will prepare (or work with PTM team to review) the User Stories based on approved product roadmap
  • Elicit requirement based on source. This may mean working with customers or any internal team
  • Development of use case scenarios
  • Analyze and Research for business need, completeness etc. and also look at harmonizing the requirements to suite usage by many customers
  • Review with Domain Experts (DEs) the requirements defined
  • Identify Non-functional requirements (e.g. SaaS requirements, Performance etc.)
  • Will ensure the requirements defined are correctly and completely developed in the application
  • Review of User stories / Functional Specifications
  • Review of Business scenarios for testing 
  • Review of alpha and beta releases
  • Define acceptance testing criteria
  • Will be responsible for defining scope for update and patch releases
  • Will be responsible to make general availability releases of products
  • Will be responsible for managing the development of the Prototype for select functionality to complement the user stories.
  • Will do knowledge transfer of the requirements to Product Engineering and other teams
  • If required, will be conducting functional training sessions to PE, implementation and customer support, sales etc.
  • Will provide Functional input to RFI, RFP etc.
  • Manage and co-ordinate the work of reporting Business Analyst/s