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14 days old

Project Manager - Scientific

Kelly Services
Deerfield, IL 60015
Kelly Services is currently seeking a Project Manager in Deerfield, IL to work a contract assignment of 12 months for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.



**Primary Responsibilities of the** Project Manager **includes:**



Deliverable Project Manager




+ The healthcare industry requires that we abide by medical device regulations from around the world.

+ Part of the requirements is to produce documents which describe the safety and performance of our medical devices.

+ We are looking for individuals to manage the execution and successful completion of document deliverables to ensure required timelines are met.

+ The ideal candidates must have project management experience, be fluent in English (both writing and speaking) and possess critical thinking and analysis skills.



Essential Duties and Responsibilities:




+ Facilitates communication between the WWM-S&D Team, Subject Matter Experts (SMEs), and the Medical Writer (internal or external vendor) to ensure on-time delivery of high-quality regulatory documents for medical devices, Risk Class I through III.

+ These regulatory documents include: Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up Plans and Reports (PMCFPs, PMCFRs), and Summary of Safety & Clinical Performance (SSCPs).

+ Manages the successful completion of deliverables for regularly scheduled updates (On-Cycle Periodic Review/Updates) as well as ad-hoc updates (Off-Cycle Updates)

+ Develops deliverable project plans/schedules; working closely with the Master Schedule Manager and Medical Writer to ensure timelines are met.

+ Schedules deliverable kick-off meetings to confirm deliverable scope, project schedule, assigned SMEs, and availability of source documents.

+ Ultimately responsible to drive the effort in successfully delivering the required documents by the required timelines. If anything places that delivery at risk, collaborates with cross functional business partners to mitigate that risk.

+ Owns the historical context of each of the deliverables including why historical decisions were made around each of the assigned deliverables. Communicates this context during the next document update and ensures the correct decisions are made based on this history.

+ Proactively partners with cross functional business partners (i.e., SMEs) such as WWM-Medical Affairs, Post Market Surveillance (PMS), Quality, Research & Development (R&D), Regulatory Affairs (RA), and potentially external vendors.

+ Collaborates with Medical writers and ensures all source documents are obtained timely from Team Center Database or SMEs. If vendor is not contracted to provide this data gathering scope, Deliverable PM will gather the source documents.

+ Implements an effective communication model with cross functional team members that provides deliverable status updates and supports timely completion of deliverables.

+ Anticipates potential deliverable schedule conflicts and challenges for proactive solutions and manages deliverable schedule for win-win results.

+ Ensures escalation of risk management response strategies to leadership within WWM, as well as SME Leadership Team.

+ May participate in workshops and company initiatives to help define processes globally and to provide best practices for continuous process improvement.



The Project Leader must demonstrate:




+ Expertise in project management

+ Excellent oral and written communication skills

+ Strong organizational skills, attention to detail, and business acumen

+ Must possess knowledge and expertise in Microsoft Word, Microsoft Excel, Microsoft Project and Adobe Acrobat products. Knowledge in Microsoft Visio is a plus.

+ Must have a flexible mindset, able to work in a fast-changing environment with competing priorities

+ Able to problem solve and resolve issues/obstacles to successfully meet deliverable timelines

+ Proven ability to work collaboratively with cross functional teams to meet timelines where competing priorities may exist

+ PMI or IPMA or equivalent certification preferred

+ Experience within the medical device industry preferred



Strongly Desired:

1. At least 3+ years of on-the job project management experience

2. NPD (New Product Development) project management experience particularly in the Life Sciences a plus

3. Experience in a highly matrixed organization

4. Experience running a project in a multi-cultural/global setting

5. PMI or IPMA or equivalent certification preferred

6. Experience within the medical device industry preferred

7. Software: Microsoft: Word, Excel, Outlook, Project and PowerPoint; Adobe Acrobat products; Knowledge in Microsoft Visio is a plus.

8. Local candidates preferred, but not required (must be able to work on an EST schedule)



**Education and Experience Requirement of the** Project Manager **includes** :




+ Minimum of a Bachelors Degree (discipline Business or Sciences preferred)

+ At least 3 years of on-the-job project management experience required



**Additional Information:**




+ Contract assignment, duration 12 months.

+ Work schedule: full-time, first shift.



**Kelly Temporary Employee Perks:**




+ Group medical, prescription, vision, dental, life, and short-term disability insurance options that are available for purchaseand the coverage is portable*

+ Service bonus plan and Holiday pay plan, if qualified

+ Weekly electronic pay options

+ Free online training campus available

+ Exclusive online employee community

+ Corporate discounts



**Apply Now!**



This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position you must submit your resume to the Scientific Recruiter listed below:



Please email your resume directly to Sandy at: Sanm174@KellyServices.com [reference BH Job #2611728]



Thank you for your interest in the assignment.






**Why Kelly** **** **?**



Kelly Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2020-06-29 Expires: 2020-07-30

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Project Manager - Scientific

Kelly Services
Deerfield, IL 60015

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