Talent.com
Submission and Assessment Specialist, Full-Service REMS

Submission and Assessment Specialist, Full-Service REMS

Syneos Health / inVentiv Health Commercial LLCMorrisville, NC, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Description

JOB SUMMARY

A Senior Manager in Strategy is an experienced project leader in the Global Risk Management and Full-Service REMS (GRMR) Business focused on Strategy, Submissions and Assessments. Expectations include the ability to build relationships (internally and externally), identify client needs, design strategic and innovative solutions, manage client deliverables, coordinate with other internal program representatives, and deliver to clients on time, on budget and within scope. This practiced professional exhibits decision quality, action orientation, communication savvy, and resourcefulness as the primary steward of client(s) GRMR Strategy, Submission and Assessment projects.

JOB RESPONSIBILITIES

Productivity

  • Builds positive working relationships with clients, staff, managers, leadership, and internal support teams.
  • Achieves billable utilization and managed book of business targets in service to client engagements.
  • Proactively seeks opportunities to build skills, experiences, and relationships by contributing to program engagements and internal initiatives.
  • Manages heavy workloads and competing responsibilities.

Delivery

  • Responsible for creation, maintenance and evolution of customer strategy, submission and assessment activities / workstream
  • Lead projects with cross functional involvement and supervise all functional areas that participate in strategy, submission and assessment activities
  • Ability to support multiple programs / projects simultaneously
  • Ability to understand and manage complex REMS program ETASU deliverables
  • Works with project teams on responses to FDA information requests
  • Provide subject matter expertise to project teams as they conduct activities
  • Maintain, prioritize and execute schedule of contracted submission and assessment projects
  • Collaborates with core team and oversight roles to design, manage, and execute all aspects of a client engagement according to the customers business goals and expectations. Coordinates with additional support teams as needed through program lifecycle.
  • Optimizes work processes to maintain program scope, budget, timelines, and resource allocations. Accountable for project activities and leverages internal tools and tracking systems to ensure program objectives, milestones, and timelines are met.
  • Attends client meetings and supports presentations as applicable
  • Focal point for resolving project team member questions around strategy, submission and assessment activities
  • Serves as the liaison with customer(s) for strategy, submission and assessment related questions and escalations
  • Proactively escalates problems as they emerge to project leaders.
  • Ensure project is conducted according to Syneos Health and customer SOPs, as applicable
  • Maintain project documentation to be "audit ready"
  • Participate in sponsor / regulatory audits as required
  • Leverages critical thinking and problem-solving skills to recommend creative ideas based on data analysis, personal experience, team guidance and industry best practices.
  • Works with program management / leadership to challenge and pressure test client recommendations, when appropriate. Anticipates and supports client needs, concerns, and challenges through the design of alternatives and contingency plans. Demonstrates resourcefulness.
  • Navigates and resolves project ambiguity, client changes, delays / expedites, and / or unexpected findings with maturity and professionalism. Maintains regular communication with program leadership
  • Communicate with clients, team members, and program leadership on a regular basis. Proactively communicates when timing is at risk. "Manages up" to keep program leadership informed of activities, team dynamics, project status, scope changes, potential risks, and business development opportunities
  • Exhibits professional, positive, respectful, and mature interactions internally & externally
  • Other duties as assigned
  • Community

  • Actively participates in company-sponsored events, training and professional development opportunities, meetings, and office and Advisory Group initiatives.
  • Drives a positive, collaborative, and professional team culture through words, attitude, and actions.
  • Understands personal strengths and development needs. Seeks feedback and coaching. Sets annual professional development goals and engages in appropriate developmental stretch opportunities.
  • Proactively seeks opportunities to expand knowledge of the biopharmaceutical industry, Consulting service offerings, and client products and markets. Deepens expertise in REMS requirements, service offerings, and / or functional areas.
  • Demonstrates Syneos Health core values in action and word
  • QUALIFICATION REQUIREMENTS

  • Bachelor's or higher degree (e.g. MBA, PhD, PharmD) in business or life sciences, or PMI Certified Associate in Project Management (CAPM) / Project Management Professional (PMP) or equivalent with significant experience (5+ years)
  • Background in regulatory, medical writing or FDA interactions preferred
  • Ability to assess client needs and deliver high-quality, effective communications
  • Must be fluent in English (written and spoken) with excellent PC skills including Microsoft Office, Internet fluency and other related tools
  • Excellent interpersonal, communication, presentation and influencing skills
  • Familiarity with Project Management tools (e.g. MS Project, SharePoint)
  • Demonstrated project management experience required
  • Experience managing successful working relationships in a cross-functional, matrix environment
  • Ability to multi-task, think critically and prioritize competing high focus priorities
  • Skilled in directing the work of others and driving results
  • Aptitude for translating ambiguity and uncertainty into actionable next steps through resourcefulness, resiliency, and adaptability
  • Strong meeting facilitation skills
  • Excellent time-management skills
  • The annual base salary for this position ranges from $132,685 to $179,515. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. In addition, some positions may include eligibility to earn commissions / bonus based on company and / or individual performance.

    At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

    Why Syneos Health? Here, you're a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world.

    W o r k H e r e M a t t e r s E v e r y w h e r e | How are you inspired to change lives?

    Syneos Health companies are affirmative action / equal opportunity employers (Minorities / Females / Veterans / Disabled)

    Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.

    At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.

    serp_jobs.job_alerts.create_a_job

    Assessment Specialist • Morrisville, NC, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Travel Emergency Department RN

    Travel Emergency Department RN

    Premier Medical Staffing ServicesLouisburg, NC, US
    serp_jobs.job_card.permanent
    Premier Medical Staffing Services is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Louisburg, North Carolina. Job Description & Requirements.Premier Medical Sta...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Board Certified Behavioral Analyst (BCBA) - School in Wake Forest, NC

    Travel Board Certified Behavioral Analyst (BCBA) - School in Wake Forest, NC

    AlliedTravelCareersWake Forest, NC, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with Aequor to find a qualified BCBA - School in Wake Forest, North Carolina, 27587!.Aequor is now hiring a full-time Board Certified Behavior Analyst (BCBA) for the ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    SPEECH LANGUAGE PATHOLOGIST (SLP) - GOLDEN YEARS NURSING HOME

    SPEECH LANGUAGE PATHOLOGIST (SLP) - GOLDEN YEARS NURSING HOME

    Liberty HealthFalcon, NC, US
    serp_jobs.job_card.full_time
    SPEECH LANGUAGE PATHOLOGIST (SLP) - GOLDEN YEARS NURSING HOME.Liberty Healthcare and Rehabilitation Services,.We are currently seeking an experienced : . Work with a multidisciplinary team to insure a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Intake Specialist

    Intake Specialist

    VirtualVocationsRaleigh, North Carolina, United States
    serp_jobs.job_card.full_time
    A company is looking for an Intake Specialist to manage patient referrals and support operational processes.Key Responsibilities : Accurately enter patient referrals and communicate with referral ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    CERTIFIED OCCUPATIONAL THERAPY ASSISTANT (COTA) - LOUISBURG HEALTH & REHAB CENTER

    CERTIFIED OCCUPATIONAL THERAPY ASSISTANT (COTA) - LOUISBURG HEALTH & REHAB CENTER

    Liberty Healthcare ManagementLouisburg, NC, US
    serp_jobs.job_card.full_time
    Liberty Healthcare and Rehabilitation Services,.We are currently seeking an experienced : .CERTIFIED OCCUPATIONAL THERAPY ASSISTANT (COTA). Work with a multidisciplinary team to insure a wonderful reh...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Clinical Research Lead Assistant

    Clinical Research Lead Assistant

    VirtualVocationsDurham, North Carolina, United States
    serp_jobs.job_card.full_time
    A company is looking for a Site Management Associate I / Clinical Research Lead Assistant.Key Responsibilities Coordinate and schedule internal and external meetings and provide administrative su...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Travel Emergency Department RN

    Travel Emergency Department RN

    AHS StaffingLouisburg, NC, US
    serp_jobs.job_card.full_time
    AHS Staffing is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Louisburg, North Carolina. Job Description & Requirements.Pay package is based on 12 hour shifts a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Learning Management System Specialist

    Learning Management System Specialist

    VirtualVocationsRaleigh, North Carolina, United States
    serp_jobs.job_card.full_time
    A company is looking for an HR Learning Management System Specialist.Key Responsibilities Lead the establishment and enforcement of LMS security roles, registration, scheduling, and cancellation ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Senior Prevention Specialist

    Senior Prevention Specialist

    VirtualVocationsRaleigh, North Carolina, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Prevention Technical Assistance Specialist (Sexual Assault Prevention and Response Office). Key Responsibilities Design training and practical learning tools with...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Tax Expert - Onsite

    Tax Expert - Onsite

    IntuitCREEDMOOR, North Carolina, United States
    serp_jobs.job_card.full_time
    Intuit is seeking highly motivated individuals to join our dynamic team as dedicated TurboTax Live Seasonal Local Service Experts in one of our new TurboTax locations across the United States on a ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    RN - Telemetry in Spout Springs, NC - $2,415 / week

    RN - Telemetry in Spout Springs, NC - $2,415 / week

    Vetted HealthSpout Springs, NC, US
    serp_jobs.job_card.full_time
    Vetted is seeking a RN - Telemetry for a travel job in Fayetteville, North Carolina.The job was posted 15 days ago.The assignment starts on ASAP and is 13 weeks long with 10 hour shifts 5 days a we...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Travel Emergency Department RN - $1,788 per week

    Travel Emergency Department RN - $1,788 per week

    Premier Medical Staffing ServicesLouisburg, NC, United States
    serp_jobs.job_card.full_time +1
    Premier Medical Staffing Services is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Louisburg, North Carolina. Job Description & Requirements.Premier Medical Staffin...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Learning Operations Analyst

    Learning Operations Analyst

    VirtualVocationsDurham, North Carolina, United States
    serp_jobs.job_card.full_time
    A company is looking for a Learning Operations Analyst to support learning programs and Learning Management Systems (LMS). Key Responsibilities Partner with instructional designers and stakeholder...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    LMS Training Assistant

    LMS Training Assistant

    VirtualVocationsDurham, North Carolina, United States
    serp_jobs.job_card.full_time
    A company is looking for an LMS Training Assistant.Key Responsibilities : Oversee the department Service Desk, managing service request tickets related to LMS issues and updating user learning pla...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Clinical Trials Associate

    Clinical Trials Associate

    VirtualVocationsRaleigh, North Carolina, United States
    serp_jobs.job_card.full_time
    A company is looking for a Clinical Trials Associate responsible for clinical trials administration to ensure the effective conduct of clinical research studies. Key Responsibilities Support Clini...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Regional HR Business Partner-Southern U.S. Field Operations

    Regional HR Business Partner-Southern U.S. Field Operations

    Vaco by HighspringFour Oaks, North Carolina, United States
    serp_jobs.job_card.permanent
    Regional HR Business Partner-Southern U.Regional Travel throughout North Carolina, South Carolina, and Georgia.Based in Raleigh-Durham Metro-Area, NC OR Charlotte-Metro Area, North Carolina.Onsite ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    RN - Telemetry in Spring Lake, NC - $2,415 / week

    RN - Telemetry in Spring Lake, NC - $2,415 / week

    Vetted HealthSpring Lake, NC, US
    serp_jobs.job_card.full_time
    Vetted is seeking a RN - Telemetry for a travel job in Fayetteville, North Carolina.The assignment starts on ASAP and is 13 weeks long with 10 hour shifts 5 days a week. You must live 60 miles away ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Learning Management System Assistant

    Learning Management System Assistant

    VirtualVocationsRaleigh, North Carolina, United States
    serp_jobs.job_card.full_time
    A company is looking for a Learning Management System (LMS) Training Assistant.Key Responsibilities Manage the department Service Desk by assigning and resolving service request tickets Perform ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours