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Senior Regulatory Lead
hace 2 semanas
**Description**
**Senior Regulatory Lead
- EMEA based**
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
**Why Syneos Health**
- #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
**Job responsibilities**
- Provides oversight of all project SSU activities which encompasses all activities for life cycle maintenance amendment deliverables.
- Collaborates with all major functional area leads including SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing.
- Ensures all project deliverables meet the internal customers’ expectations and the contracted deliverables and any key performance indicators, providing accurate projections, quality of output, reports and updates, and ongoing risk assessments, as per manager’s instruction.
- Develops and maintains relationships with customers in alignment with their assigned projects. Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed.
- Assumes accountability on SSU deliverables including, but not limited to:
- Life cycle maintenance amendment activities;
- Communication and coordination with country start-up specialists for all RA, IEC/IRB submission deliverables;
- Overall SSU timelines for life cycle maintenance amendment activities;
- Communication and coordination with Site Contract Negotiator(s) for amendments to contracts and/or budget independent to the submission deliverables.
- Maintains plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Complies all controlled document requirements and other requirements to ensure quality deliverables.
- Manages life cycle maintenance activities’ timelines and reports weekly progress including plans to address any potential timing risks/gaps and prepares and presents regulatory strategy and status at client meetings and communicates outcomes to project team.
- Ensures adequate monthly reporting through Executive Summaries or equivalent tools.
- Reviews the project budget for out of scope activities for life cycle maintenance activities in collaboration with Project Lead (PL) to ensure project profitability.
- In collaboration with the PL, reconciles revenue units completed and projects future units on a monthly basis
- Uses corporate tools for planning and management of scope, timeline, and resources and ensures minimum hours are used for tasks. If out-of-scope work is requested, calculates the units required or designee and notifies the PM. Provides assistance in financial oversight to more junior members.
- Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams and oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Project teams
- Liaises with the appropriate stakeholders to request resources for project activities. Ensures systems are accurately populated and highlights to the country managers if allocation is insufficient.
- Accountable for the timely follow-up for Ethics Committee/Regulatory Authority enquiries or objections in collaboration with the country SSU Specialists. Meets or expedites the planned submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, pro-actively solves or escalates the problem quickly.
- Oversees the timely provision for filing of submission documents to the study’s Trial Master File in collaboration with the country start-up specialist.
- Ensures timely and accurate filing of documents owned by their role.
- Identifies best practices and participates in process improvement i
