Project Manager, Scientific Operations Technical & Medical Writing
The Scientific Operations (SciOps) Project Manager will lead project management activities associated with the execution of medical & regulatory documentation including Clinical Evaluations, Literature Reviews, and Periodic Safety Update Reports. The Project Manager will focus on providing leadership and support to program level activities such as submissions and inquiries with Notified Bodies, managing the organization's translation program, supporting business planning and finance processes, and supporting process improvement initiatives.
Additionally, the Project Manager will support a team of technical managers and medical writers using project management tools and established processes in a global setting. Specifically, the project manager will support multiple MedTech portfolios with a focus on Electrophysiology, Neurovascular Care, and/or Aesthetic Reconstruction products. The project manager will maintain relationships through extensive interdependent partnering, benchmarking, and forming strategic alliances with cross functional business partners to drive key business goals and objectives. The project manager should have a pro-active, can-do attitude, a high level of personal initiative, and the ability to function with minimal supervision.
Responsibilities:
Leads end to end project management activities including project plan development, dashboard generation, metrics tracking, risk identification and mitigations, resource planning, and development communication strategies.
Supports a team of scientists, engineers, and medical professionals across multiple businesses to gather and analyze product related safety and performance data. Defines deliverables & project milestones. Prioritizes and navigates competing demands and projects.
Is responsible for the effective optimization and harmonization of Scientific Operations processes within MedTech incorporating process excellence tools while aligning with available guidelines. Supports creation of project value propositions as needed.
Provides strong connectivity with Medical Affairs, R&D, Regulatory Affairs, and Clinical Affairs partners and leverage capabilities from the central team across franchises.
Ensures deliverables are linked to appropriate Quality Systems and Regulatory Processes to ensure information is accessible where needed. Supports document creation, preparation, routing, and management.
Maintains and monitors metrics relevant to the team's activities providing visibility of issues to enable corrective and preventive action to be taken, as needed
Assists with project delivery resources and provides guidance and direction to achieve project goals.
Implements project plans as directed by department leaders.
Qualifications:
Required:
Minimum of a Bachelor's degree (University Degree), and 3 years of combined related experience on project management, project coordination, or document coordination
Proficient using Microsoft Applications (Word, Excel, Outlook, Teams, and PowerPoint), and Adobe Acrobat
Proficient with project planning tools such as Wrike, MS Project, or Smartsheet
Strong written and oral communication skills across different organization levels
Preferred:
Prior experience in medical devices or other regulated industry
Knowledge of clinical evaluation or literature reviews inputs and requirements
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
