Please note that this position can be based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.
Position Summary:
This role will work closely with the other team members in Quality Risk & Compliance (QRC) to assist in assessment, reporting on compliance and improvement of processes, tools and systems for Acadia clinical trials' execution in a Good Clinical Practices (GCP) regulated environment. Additional areas of support include Good Pharmacovigilance Practices (GvP), and Good Laboratory Practices (GLP). Involvement in process improvement projects with Subject Matter Experts (SMEs) of multiple functions in clinical research and other departments, is often part of daily activities. This position requires great timekeeping skills, interpersonal collaboration and a great level of independence to carry out assigned tasks.
Primary Responsibilities:
- Independently calculate, track, QC, and report assigned Key Quality Indicator (KQI) metrics as surrogates for process compliance (semi-automated metrics and manual Spot-Checks) in order to reinforce adherence to processes and procedures and to identify areas for improvement. Liaise between QRM team and clinical study team members on responses to escalations and when thresholds are reached.
- Create and design, where appropriate, KQI metrics / Spot-Check instructions to harmonize the calculation and reporting to R&D functional areas and other departments. Suggest automation and improvements to KQI calculations, where applicable. Contribute to the automation efforts with the owner of the KQI or the system component.
- Assist QRM team members with the creation and maintenance of a regulatory framework for Quality Risk Management (QRM) related activities, including review or creation of Controlled Documents (e.g. SOPs, Work Instructions) and/or tools, and templates. Assisting in creation of eLearnings, training materials related to GCP, GLP, GvP.
- Where assigned, provide support to a clinical study team, provide independent feedback in case of study- or clinical site-specific compliance issues, study risks and work with study teams on implementing and documenting solutions and preventive measures, where appropriate. Lead Study-specific staff members through the Veeva Quality Management System (QMS) process for Deviation and CAPA Management, if applicable.
- Contribute and lead the implementation of Process Improvements in the Acadia R&D (Research & Development) and/or GMP space and contribute to oversight of Process Improvement projects and assist with project management activities as part of the PI3 (Process Improvement and Innovation Ideas) process. Act as SME on Process Improvement initiatives, including brainstorming, risk assessments, implementing changes and action planning, where assigned.
- Contribute to User Requirement assessments and User Acceptance Testing (UAT) for general technology implementation of new or updated IT applications used for clinical trial management.
- Also contribute to activities related to Health Authority Inspections, under supervision of senior members of the Quality team.
- Assist in onboarding of other (new) members of the QRC team where applicable.
Education and Experience
Bachelor’s degree in life sciences, neuroscience, psychology, biochemistry, engineering, Quality (and/or Risk) Management, Clinical Pharmacology or related field. Targeting 2+ years of Pharmaceutical/Health Care experience in a R&D regulated environment including some experience in Risk-Based Quality Management or R&D Quality Assurance systems and Health Authority regulations (e.g. ICH E6; FDA 21 CFR). An equivalent combination of relevant education and applicable job experience may be considered.
Key Skills:
- Experience with R&D specific IT application systems for document, data and trial management, and/or Pharmacovigilance.
- Experience with data visualization and/or analytics tools and ability to build, program and modify new reports and visualizations.
- Experience with Clinical Trial related systems, e.g. Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF, preferably Veeva Vault), Electronic Data Capture (EDC, preferably Medidata RAVE) and Large Scale Data Analytics (such as SpotFire, CluePoints, JReview or similar).
- Highly proficient in Information Technology systems, including Microsoft Office suite and related generative A.I. systems.
- Proven experience in time management, and good email practice in order to work on multiple assignments at the same time.
- Proven record of working inside a team with different colleagues in any position, including being in the Lead. Being able to tailor feedback on compliance to different levels in the organization from Assistant roles to executive VP levels and in between.
- Knowledge of statistical methods and being able to apply that to detect outliers in data sets and/or to create thresholds such as Quality Tolerance Limits (QTLs) as required by ICH E6 (GCP) is a strong preference.
- Strong preference for candidates with a Project Management certificate and/or proven experience in project management for R&D related projects.
- Pursuing or in possession of a (Lean) Six Sigma certification (yellow, green, black, or master black belt) is a big plus
- Strong analytic skills for large quantities of compliance, risk management and clinical data and calculation of related KQIs and Spot Checks depending on those data sets.
- Strong interest in Pharmaceutical Development, mainly in the clinical research (R&D) aspects of drug development.
- Interest in, and/or experience with organizational change management, as it relates to embracing and promoting a culture of quality.
- Ability to travel in exceptional cases.
Scope
Works both as a member of teams as well as independently without direct supervision. Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors ad an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.
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 and independently from remote locations. Employee must occasionally lift and/or move up to 50 pounds. Ability to travel independently overnight up to 10% of the time and work after hours if required by travel schedule or business needs.
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In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.
What we offer US-based Employees:
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- Employer-paid life, disability, business travel and EAP coverage
- 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
- 13 -15 paid holidays, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave benefit
- 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 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 strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe 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 accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
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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 the absence of an executed search agreement will not obligate Acadia in any way with 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.
Skills Required
- Bachelor's degree in life sciences, neuroscience, psychology, biochemistry, engineering, Quality/Risk Management, Clinical Pharmacology or related field
- Minimum 2+ years pharmaceutical/healthcare experience in an R&D regulated environment with exposure to Risk-Based Quality Management or R&D Quality Assurance and ICH E6; FDA 21 CFR
- Experience with R&D IT application systems for document, data and trial management and/or pharmacovigilance systems
- Experience with data visualization and/or analytics tools and ability to build, program and modify reports and visualizations
- Experience with clinical trial systems (CTMS, eTMF preferably Veeva Vault, EDC preferably Medidata RAVE) and large-scale analytics (SpotFire, CluePoints, JReview or similar)
- Highly proficient in Microsoft Office and related generative AI systems
- Proven time management, multitasking, and professional email/practice skills
- Proven ability to work collaboratively and provide tailored compliance feedback to all organizational levels
- Experience with User Requirement assessments and User Acceptance Testing (UAT) for clinical/IT applications
- Ability to support Health Authority inspection activities and QMS processes (Deviation/CAPA management in Veeva QMS)
- Knowledge of statistical methods to detect outliers and set Quality Tolerance Limits (QTLs) per ICH E6
- Project Management certification or proven project management experience for R&D projects
- Pursuing or possession of Lean Six Sigma certification (yellow/green/black/master black belt)
- Ability to travel overnight independently up to 10% of the time and work after hours as needed
What We Do
Our Acadia family of care-ageous warriors aspire to enable brighter moments for patients and their loved ones. For 30 years, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapies for hallucinations and delusions associated with Parkinson’s disease psychosis and for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Alzheimer’s disease psychosis and neuropsychiatric symptoms in central nervous system disorders. Important Notice for Candidates - Be Aware of Fraudulent Recruiting Activity Acadia Pharmaceuticals has become aware of fraudulent recruiting activity being circulated via email and LinkedIn by individuals impersonating Acadia Talent Acquisition employees. These communications may appear legitimate due to an official-looking Acadia email address or website, referencing of an actual recruiter and/or manager at Acadia (easily found on LinkedIn), and/or offer documents falsely signed by an Acadia executive. The impostor uses the incentive of a job interview and job offer to solicit sensitive personal information from the intended victim. Please note that the Acadia Talent Acquisition and HR Team will ONLY interact with a candidate from "Acadia-pharm.com" domain sourced emails. We do not request sensitive personal information, such as a Social Security Number, or payments of any kind during the interview or job offer process. Acadia strongly recommends individuals, who receive email solicitations, to carefully verify the authenticity of the correspondence before responding. Never provide personal information or click on links if you are unsure a communication’s legitimacy. If in doubt, please contact [email protected] to verify.
