Location: West Point,PA, USA
**Job Description**
Our company is a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
Employees within the Regulated PK/ADA Bioanalytical Outsourcing group provide oversight for outsourcing of regulated clinical and preclinical assay method development, validation, and sample testing in support of biologics and small-molecule programs. This group is seeking a dynamic and collaborative employee with project management experience to provide strategic oversight for bioanalytical outsourcing. Job responsibilities will support third party lab operational oversight and associated activities including management of assay transfer and validations, study sample analysis contracting, relationship management, meeting organization, and vendor performance to ensure quality, timeliness, and compliance of outsourced bioanalytical work.
**PLEASE NOTE THAT THIS IS NOT A LABORATORY-BASED POSITION.**
**Job Summary:**
Our company's Regulated PK/ADA Bioanalytical Outsourcing (PDMB Outsourcing) Group is seeking a highly motivated Project Manager to join our dynamic team. The successful candidate will play a crucial role in tracking outsourced bioanalytical projects and ensuring smooth coordination between internal teams and external partners. This position offers an excellent opportunity to enhance project management skills in a fast-paced, scientifically driven environment.
**Specific Responsibilities include:**
Project Coordination: Support the planning, tracking, and monitoring of bioanalytical PK and ADA projects outsourced to Contract Research Organizations (CROs). Develop and maintain dashboards and provide updates to outsourcing leads and internal customers. Embrace opportunities for automation to achieve a high performing organization.
Communication: Serve as a point of contact between internal company stakeholders (e.g., scientific teams, procurement, and quality) and external partners regarding communication of project milestones, timelines, and deliverables. Organize meetings between internal teams and external partners, assist with site visit and travel planning, slide preparation, SharePoint management, and vendor performance plans.
Timeline Management: Track project timelines, deliverables, and milestones. Work closely with internal team members and customers to confirm deliverables are provided on time.
Cross-Functional Collaboration: Work closely with stakeholders to facilitate seamless project execution.
Documentation: Ensure all project-related documentation, contracts, and agreements are accurately maintained/updated and compliant with company policies.
Issue Resolution: Identify project risks/delays and work proactively with the Outsourcing Leads and teams to implement solutions.
Budget Management: Assist in forecasting and tracking project budgets.
**Required Qualification and Skills:**
+ Bachelor's degree in Life Sciences, Chemistry, Business, or a related field.
+ Demonstrated project management skills and/or certification.
+ Familiarity with project management methodologies or software tools (e.g., MS Project, Smartsheet, PowerBI, or similar). Experience with automation to optimize efficiency.
+ Excellent verbal and written communication skills.
+ Ability to work collaboratively in a team environment.
+ Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint, Project Management tools).
+ Knows when and how to speak up and appropriately raise issues to the team and management.
+ Travel Requirements: 20%
**Preferred Experience and Skills:**
+ Prior internship or work experience in the pharmaceutical or biotech industry.
+ Experience with process improvement methodologies (e.g. Six sigma, process mapping, Kaizen).
+ Basic knowledge of bioanalytical sciences, outsourcing, and immunoassay and LC/MS assays.
+ Strong organizational and multitasking skills.
+ Familiarity with regulatory requirements related to bioanalytical studies is desirable.
+ Experience managing budgets and providing financial forecasts.
**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.
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**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here ( if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
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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, Monday - 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 .
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**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:**
Regular
**Relocation:**
Domestic
**VISA Sponsorship:**
No
**Travel Requirements:**
25%
**Flexible Work Arrangements:**
Hybrid
**Shift:**
Not Indicated
**Valid Driving License:**
No
**Hazardous Material(s):**
N/A
**Job Posting End Date:**
11/13/2024
***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:** R318606