ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date.
ERT Boston is looking to hire a Product Manager to deliver measurable business results through product solutions that meet both market needs and company goals. In this role you will manage all aspects of the Product Life Cycle for Products (defined as products, devices and services) in a new or established Product line. You will define user stories for new Products, and drive internal teams to the successful launch, market adoption, serviceability and profitable market growth of those Products. The Product Manager supports the business as the expert for their products
Business and Market Planning
- Identify market segments and opportunities for new Products
- Analyze market trends, potential customers, competitors
- Drive and capture innovative market and Product ideas from throughout ERT
- Evaluate customer needs to determine suitability for ERT Product opportunities
- Initiate and develop business plans in support of new Product strategies
- Manage Product Programs
- Develop an intimate knowledge of customer needs and competitive intelligence, identify global market trends and drivers, and formulate and execute strategic product portfolio planning (Build/Buy/Partner strategies)
- Obtain customer requirements and specify product and service features including road maps via market research, market analysis, and ongoing communication with marketing, sales, and operations, as well as 3rd party sources in order to meet customer needs
- Develop detailed marketing requirements specifications:
- Work with other functional groups (especially Project Leads and Product Development) to develop final product requirements for new products
- Work with Operations to develop final service requirements for new Products
- Work with QA/RA to determine regulatory constraints
- Validate market requirements to ensure acceptance
- Leads development of critical marketing documents to enable successful Product delivery efforts (i.e., Opportunity Overview, Market Requirements Documents, Product Launch Packages):
- Lead cross-functional product teams through the strict compliance of all steps of the Product Life Cycle
- Ensure that critical pricing, cost requirements, and ROI models are central to the Product planning process
- Define and develop positioning, pricing, channel and promotional plans for new and existing Products and manage launch plans
- Lead and drive all Go-to-Market efforts for product launch cross functionally
- Product Life Cycle Management
- Lead internal company communications for all Product-related information
- Lead internal efforts to move any assigned Products through the Product Life Cycle process
- Coordinate priorities with the Product Review Board
- Is responsible for ensuring the managed product category complies with local and international quality standards as well as internal ERT Quality Management System and Product Lifecycle requirements from product inception to retirement (*This includes but is not limited to Product Planning, Development, Testing, Maintenance and End of Life processes)
- Business Management
- Monitor ongoing Product success in the market including:
- Financial management
- Customer satisfaction
- Communicates all potential risks (regulatory or other); operational deviations including summary root cause and CAPA metrics to ERT Executive Management personnel as necessary
- Business Relationships
- Identify and develop third party business opportunities for software or hardware products to complement ERT’s line of Products
OTHER DUTIES AND RESPONSIBILITIES:
- Provide input for product management best practices and SOPs.
- Train internal users and sales team on new product releases including features and benefits; manage the creation of effective product demonstrations and train sales force on demonstration execution.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. ERT reserves the right to amend or change this job description to meet the needs of ERT. This job description and any attachments do not constitute or represent a contract.
- Bachelor’s Degree (business or science-related field preferred); Master’s Degree in Business Administration or Technology or Technology/Science preferred
- At least 3-5+ years of experience in product management
- Ability to travel 40%+
- Proven leadership and decision-making ability
- Excellent team and leadership skills
- Demonstrated leadership in executing market research (voice of customer), identifying unmet market needs, and translating those needs into business opportunities
- Demonstrated business and project planning skills and track record of defining, developing, and launching successful software products
- Ability to synthesize information into a compelling story
- Customer focus with interpersonal and influencing skills across the organization
- Excellent written, verbal, and presentation skills in English language
For those positions managing (medical) devices, these additional qualifications apply:
- Experience with (medical) devices and related technologies
- Experience developing specifications for (medical) data management, data transfer and data storage systems including relevant standards
- Experience creating medical data management, data transfer and data storage systems including relevant standards
- Experience creating (medical) devices including documentation (technical file) for CE marketing, FDA 510(k) and other country approvals
- Experience with GMP, GCP, 21 CFR Part 11, MDD; preferably trained as Medical Device Consultant
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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