Please note that this position is based in Princeton, NJ. Acadia’s hybrid model requires this role to work in our office three days per week on average.
This position will serve as a technology partner in the Research and Development (R&D) and Technology Development & Operations (TD&O) domains, providing technology leadership, operational support and project management for key projects. The IT Business Partner will work both on projects, as a critical team member, and with operational teams to help ease the introduction of new technologies and to maintain and further improve upon operational processes. The IT Business Partner will help define and document key processes, requirements, knowledge articles, and user documentation.
Primary Duties & Responsibilities:
- Act as operational lead for existing systems including holding recurring operational meetings with business partners and vendors, tracking and evaluating change requests, initiating change controls for implementation of changes, coordinating routine system patches and escalating issues as appropriate
- Work with Lead IT Business Partners to establish and enhance key relationships with business stakeholders and provide input to systems roadmaps
- Work with Business and IT Business Partners to help define and document business processes and requirements including, but not limited to, data flow, data storage, application usability, infrastructure, reporting and analytics
- Support IT project management in the implementation of technology solutions according to Acadia’s IT governance processes, including intake assessment and standard PMO reporting
- Facilitate RFP initiatives for evaluating new technology solutions
- Perform vendor management activities such as establishing contracts (e.g., NDA, MSA, SOW) and managing ongoing licensing and renewals
- Create training materials, “How To,” and knowledge items to ease user adoption of new technology
- Define standard operating procedures and perform periodic review activities for R&D systems
- Facilitate UAT with business partners
- Define, coordinate and/or execute system integration testing as needed
- Triage and facilitate resolution of application issues and escalate to vendor support as needed
- Conduct source systems data quality analysis as needed
- Perform computer systems validation activities adhering to 21 CFR Part 11 guidelines
- Provide configuration support for key ( systems, if required
Education/Experience/Skills:
Bachelor’s degree in Information Systems or equivalent technical discipline. A minimum of 8 years of progressively responsible experience in the pharmaceutical industry with a focus on R&D, Quality, and Manufacturing systems and processes, as well as computer system validation. An equivalent combination of relevant education and applicable job experience may be considered.
Key Skills:
- Experience working in a regulated environment following GxP processes
- Solid domain knowledge of business processes and related data types in functional areas (Pre-clinical, clinical development, clinical operations, regulatory, pharmacovigilance, biostatistics, data management, quality, and manufacturing), to support technology solutions
- Ability to be highly organized, self-motivated with the capability to prioritize projects and workload
- Skilled at effectively leading IT projects with cross-functional team effort and organizing resources to achieve project goals
- Adaptability to quickly and proactively implement change initiatives
- Excellent attention to detail
- Excellent interpersonal and communication skills, including tact, diplomacy, and flexibility
- Excellent skills in defining and documenting processes, requirements, and training materials
- Experience documenting SOPs and other controlled documents
- Experience with change management and computer systems validation processes
- Experience with operational systems support for key systems providing issue resolution through internal resources and vendor support
- Experience with standard systems development life cycle (SDLC) and SaaS deployment models
- Familiarity with EDC, IRT, eTMF, CTMS, SAS, Argus, clinical analytics, safety, LMS, QMS, TraceLink, Veeva Vault and/or regulatory systems
The following considered a plus:
- Familiarity with global GCP, GVP, GMP. and GLP regulations
- Experience in clinical, manufacturing, quality, and regulatory systems
- Experience supporting clinical trials in an outsourced model (working with CROs, FSPs, CSPs)
- PMP certification
Physical Requirements:
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.
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What we offer you (US-Based Employees):
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave
- Tuition assistance
EEO Statement (US-Based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
Notice for California Applicants: Please see our California Applicant Privacy Notice within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.
