Specialist, Process Engineer - Oral Solid Dosage, Clinical Manufacturing (Onsite) - Military Veterans

Job Description

Position Summary

Responsibilities :

This position supports the centralized management of technology, platforms, inspections, and related process and training for the global Statistical Programming organization. The individual supports the organization to ensure it operates in compliance with departmental and company Standard Operating Procedures, regulatory requirements, and standards.

Primary Activities :

• Business System Ownership (BSO) of platforms or applications and corresponding documents and training


• Partnership in managing, prioritizing, and implementing portfolio projects


• Drive compliance initiatives, change management and communication across multiple audiences


• Supports Audit and Inspections Center of Excellence with audits, inspections and CAPA (Corrective Action and Preventive Action) management


• Engagement with operational staff and partners globally


• Lead and actively contribute to departmental strategic initiative project teams


• Creation and maintenance of SAS/R tools used to generate metrics


• Maintenance of standard operating procedures, corresponding processes, assuring they are of high quality and complaint with regulatory requirements

Skills

Education and Minimum Requirement :

• BA/BS in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus 9 years in a clinical trial environment (Analysis & Reporting, Information Technology, Data Management etc.) in the pharmaceutical industry, and 3 years SAS or R programming experience.

• MS in Computer Science, Statistics, Applied Mathematics, Information Technology, Life Sciences, Engineering, or related field plus 6 years in a clinical trial environment (Analysis & Reporting, Information Technology, Data Management etc.) in the pharmaceutical industry, and 3 years SAS or R programming experience.

Department Required Skills and Experience:

• Effective interpersonal skills and ability to negotiate and collaborate effectively


• Effective written, oral, and presentation skills


• Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)


• A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders

Position Specific Required Skills and Experience:

• Experience gathering system user stories and documenting system requirements


• Experience authoring test cases and data sheets and executing test cases in ALM


• Broad knowledge of clinical trials processes, data structures and corresponding tools used to manage, extract, analyze & report data


• Comprehensive knowledge of reporting processes (standard operating procedures) that align with regulatory requirements (e.g., 21 CFR Part 11, ICH GCPs) and software development life cycle (SDLC)


• Understanding of Statistical, Clinical, Medical Monitoring and Data Management concepts as applied to drug/vaccine development within the pharmaceutical industry


• Ability to anticipate stakeholder requirements; focus on customers; ability to listen to and address stakeholders' needs and concerns


• Ability and interest to work across cultures and geographies including partnering with statistical programming staff in Asia Pacific and European regions and offshore programming resources


• Demonstrated ability to communicate effectively across multiple audiences and clearly explain processes and system functionality to users


• SAS or R programming experience

Preferred Skills and Experience:

• Experience with SDLC, ALM, SAS, R, Jira, Confluence, Agile, Digital SDLC


• Experience as a BSO for Good Clinical Practices (GCP) systems


• Experience as a System Business Analyst (BA)


• Experience developing and maintaining systems training content, including videos


• Experience in process assessment, improvement, and operational excellence

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NOTICE FOR INTERNAL APPLICANTS

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".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:
$135,500.00 - $213,400.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here .

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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:
Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
09/18/2024
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