The Company – Syner-G Pharma Consulting, LLC:
- A dynamic, entrepreneurial and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing, and Controls (CMC) for biopharmaceutical companies (small molecule and biologic products)
- Adept in developing risk-based CMC strategies in accordance with cGMP for 21st Century initiatives and Quality by Design (QbD) principles
- Distinguish ourselves by our passion for creativity and innovation
- Offer flexible work environment allows for on-site, off-site, and virtual-office scenarios
- Clients include national and multinational pharmaceutical companies
Duties / Expectations of the Role:
Provides program management support for Regulatory Operations, Post-approval Change Controls, and general regulatory business operations projects and initiatives for a large pharmaceutical client that may include:
- Develop, generate, track, and report teams’ performance against quantitative & qualitative key performance indicators (KPIs) in monthly reports for client and internal management.
- Track individual projects and hold consultants accountable for deliverables.
- Implement best practice business initiatives to enhance execution and streamline regulatory operations processes
- Ensure appropriate project reports are created and shared with the client and internal management through weekly, bi-weekly and monthly calls/meetings.
- Provide general project management support for Leadership Team members
- Itemize, track, and manage project deliverables to completion for the client
- Track and monitor GxP training requirements for consultant teams.
- Develop and maintain onboarding training materials and contribute to the new consultant orientation process internally and at the client.
- Supporting budget and resource management/tracking, including maintaining organizational charts, resumes and consultant profiles
- Escalate client issues/concerns internally
- Work with consultants in understanding regulatory operations for the US and other regulatory bodies
- Assist in recruiting new consultants for the project
- Mentor/coach consultants as needed
- Meet with the client on a quarterly basis in PA
- Escalate client issues/concerns internally
- Work with client and internal Steering committee in ensuring the smooth delivery of project
- Build a good working relationship with client/consultants and internal teams
- Assist with the development of internal procedures and guides
- Manage an offshore team of consultants.
- Executes tactical activities as outlined in Communications Plan, in partnership with Client, and Internal Steering committee
- Maintains SharePoint/Collaboration Site
- Works with internal team to develop any regulatory templates, business processes, and procedures to streamline projects.
- Post approval – Change Management/Change Approvals: Acts as meeting manager, coordinates schedules, agenda topics, facilitates the review process and archives meeting minutes.
- Leads all meeting planning coordination and activities related to weekly, monthly and ad-hoc regulatory meetings with clients and internal consultants
Contracting activities and KOL engagements:
- Manage the contracts process for regulatory operations contract, interfacing directly with Clients’ Contracts, Legal, Compliance, and Finance departments, including processing, tracking and archiving in all appropriate systems according to client approved procedures and policies
- Serves as the primary liaison for Clients’ Contracts, Legal, Compliance, and work with internal Legal to resolve issues within consulting agreements and service agreement
- Proactively implements business practices to report data related to consulting budget actuals, projections and variances to plan
- Bachelor’s degree in science, engineering, or business-related field; advanced degrees are a plus; Ph.D. acceptable.
- Program Management Certification is a plus.
- 2+ years’ relevant experience in the biotechnology or pharmaceutical industry
- Strong problem solving and project management skills with a proven ability to manage multiple projects and simplify/organize complex tasks
- Demonstrated experience managing projects in a global matrix/team environment
- Excellent written and verbal communication skills with a proven track record of influencing and negotiation with others
- Ability to proactively identify business problems/ risks/issues and facilitate issue resolution and risk mitigation
- Demonstrated proficiency with Microsoft Project, PowerPoint, Excel & Word
- Knowledge of US FDA regulations preferred