AddressJob Description
Responsibilities
As a Design Control andRisk Management Data Manager, you are a key member of the DeviceDevelopment Team. Your will main responsibility is to develop and manage the datarelationships through the development and life cycle of a product.
Key responsibilities includethe following:
Partner with the Design Control andRisk Management leads to determine the data relationships andmapping.
Lead data review meetings with content owners and Quality.
Create and manage data linkages and relationships. Manage open deliverables and tasks.
Manage the Global Design File from concept, launch and post market.
Support second person review with source data for regulatory filing.
Support Design Transfer and Manufacturing readiness.
Manage data management approval workflows.
Support impact assessments for design changes during development and post market.
Utilize library data to drive cross project consistency.
Become the IT system SME and trainer.
Drive continuous process improvements.
Management updates to data and templates.
Basic Qualifications
Bachelor's degree in a Science, Technology, Engineering, or Math (STEM) field
2-3 years in the medical device or pharmaceutical industry.
Additional Skills & Preferences
Demonstrated ability work multi-functional teams, work effectively across boundaries,and to effectively influence without authority
Strong collaboration skills and ability to work productively in an interdisciplinaryenvironment.
Integrated technical knowledge for ITsystem.
Excellent written and verbal communication skills, able to effectively interact at alllevels of the organization - business leaders, senior technical/scientific personnel,internal/external customers/suppliers/teammates
Strong project management skills.
#EligibleForERP
NOTICEFORINTERNALAPPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$83,100.00 - $130,900.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
YesHazardous Material(s):
N/AJob Posting End Date:
05/24/2024*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:05/24/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R294431
PDN-9c11c77f-807a-4922-892e-518d694116af
