Solution Manager, Regulatory
JOB TITLE: SOLUTION MANAGER, REGULATORY
REPORTS TO: DIRECTOR, PROFESSIONAL SERVICES
The primary responsibility of the Solution Manager will be to play the role of Subject Matter Expert (SME) in both implementation and upgrade projects for medium size projects or for a specific work stream in large projects. Solution Manager will ensure successful functional deployments of the ArisGlobal life sciences solutions and high customer satisfaction.
This position requires good domain knowledge, business process knowledge and in-depth knowledge of at least one of the ArisGlobal products including the supporting products. This position also requires good experience in implementing ArisGlobal products. The Solution Manager will also support the company’s primary goal of expanding revenue and revenue opportunities by amplifying Client Partner Team and Sales department capabilities to address topics of special expertise, current events and industry trends.
This position will support the company’s ability to address the market domains, by ensuring that industry needs and trends are documented and communicated to Global Delivery (GD), and that GD is equipped with the relevant knowledge in order to develop and implement the ArisGlobal product range in a way that can be maximally exploited.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsible for providing ArisGlobal with in depth subject matter expert level knowledge in Regulatory domain.
A. Pre-sales and marketing support:
- RFI and RFP responses for selected sessions and SOW estimates
- Pre-sales support – meetings e.g. cross sell / upsell, workshops and product evaluations
- Support Sales, CPT and Marketing to sell products, solutions with domain, business and in depth product expertise.
- Participate in the DIA, RAUG, user conf., CIG meetings as needed to promote products and services
- Contribution to marketing efforts the products and solutions.
- Provide input and support for white papers on domain and product related topics
B. Solution Manager for ProServ projects:
- Provide strategic consulting as solution partner to large organizations to make inroads for our services and product offerings
- Responsible for providing strategic solution and services to the assigned clients
- Functional ownership of the assigned projects
- Responsible for workshops planning, preparation and execution, finalizing the requirements, review the configurations with customers, conducting DITL sessions
- Support to product implementation framework and best practices. Core input provider to ISP
- Key stakeholder to achieve high level of customer satisfaction
- Knowledge hub “Go to Person” for the functional inquiries and provide expedited resolution/responses
- Conducting User/Admin advance trainings on ArisGlobal products
- Provide suggestions to the customer on validation strategy
C. Competency development:
- Organizing competency development trainings to the ProServ team
- Periodically train GSDSU team
- Build competency within business SME team by sharing knowledge and training them in the area of expertise
- Get trained by PE, PTM, SPUs and regulatory experts to build competency from domain, business and product functionality point of view.
D. Contribute to product road map:
- Work with PTM, SPU, PE as part of PSC to contribute to product roadmap by providing industry experience
- Review RDs for functional changes in the products and provide feedback
- Provide feedback during the product demos from PE/PM prior to production releases
EDUCATION AND EXPERIENCE:
- Bachelor’s degree or equivalent experience required.
- 3+ years of experience either in working pharmaceutical company or implementing solutions as SME or in similar capacity in the respective domain.
- 5+ years of experience working, implementing or developing solutions in the regulatory domainAbility to conduct workshops and perform requirement gathering
- Good knowledge and working experience on FDA, Volume 9A, MHLW and ICH regulations.
- Good understanding of 21 CFR Part 11
- In case of SA for regulatory vertical, good knowledge and working experience of EVMPD submissions
- Excellent understanding on software validation and GAMP 5
- In depth knowledge of the at least one of the ArisGlobal products in the respective domain including supporting modules is preferred (Register and agXchange RSM)
- Good knowledge about pharmaceutical business processes, data ware housing concepts, reporting and analytical experience
- Good knowledge and experience in product lifecycle management.
- Understanding of developing regulatory business processes that are optimized for achieving efficiencies and compliance.
- Software development life cycle (SDLC) process knowledge.
- Experience in working in onshore – offshore model and multicultural environment and matrix organization
- Good industry awareness (Life Science – pharmaceutical software).
- Ability to build effective working relationships.
- Self-starter, motivated and positive.
- Strong technical awareness.
- Excellent communication and presentation skill
- Long term vision – lateral thinker.
- Planning & Organizing.
- Customer awareness
Working and proficient knowledge of Microsoft Office suite (MS Word, Excel etc) and database programs experience. Knowledge of advanced report writing skills, HRIS, SAP, Quickbase, SoftTrax and SQL. General office equipment.
Must have in-depth knowledge of the Pharmaceutical and Healthcare Industry and regulatory requirements. Must be able to keep current on changing regulations.
ArisGlobal is an Equal Opportunity Employer/ Committed to Diversity