inVentiv Health 0000102372-Cont. NDA Sub. Project Mgr. in Massachusetts



Min Salary:$0.00

Max Salary:$0.00

Job Description:

Job Description:

• Provide support to ensure the Regulatory Lead and cross functional program team develop and seamlessly execute global regulatory strategies enabling successful marketing applications with Health Authorities.

• Utilize robust project management methodologies to ensure the development, utilization and continuous improvement of tools and processes to meet project deliverables.

• Ensure product specific strategies are documented, maintained, updated and proactively coordinated and endorsed by key stakeholders. Ensure transparent and constant communication of objectives and strategies across program teams, sub-teams, and senior stakeholders.

• Encourage and model creative problem solving and demonstrate innovative approaches in working within a dynamic environment. Assist regulatory lead in problem solving and generate options to enable effective and timely decision making.

• Develop and maintain project plan and ensure execution of regulatory filing focused on quality and schedule.

• Prepare and coordinate meetings including scheduling agendas, minutes, action item and decision logs and timelines. Maintain real-time project documentation to ensure alignment and agreement on tasks, timing and approach.

• Assist with the identification and elevation of potential major and critical project risks / issues as appropriate.

• As necessary, coordinate key cross-functional tasks in order to deliver high quality deliverables on schedule.

• Prepare and distribute reports and trackers to communicate updates and project status.

• Communicate and drive follow-up on action items as well as provide project status updates to internal & external Partners/Vendors/CMOs/CROs.

• Track project variances and report and prepare variance reports. Assist with the identification of root causes of variances.

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Job Requirements:

• Experience in the submission and approvals of NDAs and MAAs in the role of project manager.

• Thorough understanding of US & Global regulations, standards and guidance documents.

• Experience in Project Management leading cross-functional drug development or regulatory teams - PMP Certification or equivalent highly desired.

• BS degree in Science discipline - Chemistry, Biochemistry or equivalent with at least 3 years in a related position in industry.

• Experience corresponding and interacting with regulatory agencies, particularly with the FDA.

• Technical Writing Skills.

• Ability to effectively organize, multitask, and works in a fast-paced, deadline driven work environment.

• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.

• Strong team player that has a customer service approach and is solution-oriented.

• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

• Possess strong written and verbal communication skills.

• Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.

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inVentiv Health, Inc. is an Equal Opportunity Employer, M/F/Disabled/Vets that values the strength that diversity brings to the workplace.