Risk Management Director jobs in Trenton, NJ

Risk Management Director manages and administers an organization's risk-management programs. Implements policies, procedures, and controls to monitor and minimize the risk exposure of assets. Being a Risk Management Director researches internal and external risk factors including economic, market, and regulatory risks that may affect the organization. Routinely evaluates the effectiveness of procedures and collaborates with internal stakeholders to monitor changes in the business environment. Additionally, Risk Management Director manages statistical analysis and designing of financial models to predict the risk exposure of an organization's assets. Reviews risk analysis reports to ensure risks are identified and managed effectively. Requires a bachelor's degree. Typically reports to a director. The Risk Management Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Risk Management Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Senior Director Drug Safety & PV Risk Management
  • Acadia Pharmaceuticals Inc.
  • Princeton, NJ FULL_TIME
  • The Senior Director, Risk Management (RM) is responsible for managing the Acadia Risk Management System including the process for signal detection and safety issue assessment and for leading any related risk management or epidemiologic activities for both marketed and investigational products at Acadia. This individual ensures risk management planning and implementation activities are consistent with US, EU and international guidelines and regulations and industry best practices. This individual maintains a thorough knowledge of pharmacovigilance signal detection and risk management methods to ensure thorough monitoring of safety signals, and applicable risk mitigation strategies are in place as appropriate. This individual also provides project leadership for the development and implementation of epidemiology methods and technology used in the assessment of potential and identified risks. The Senior Director will help build the RM infrastructure to optimize benefit-risk throughout the life cycle of Acadia products.

    Primary Responsibilities

    • Leads the development and management of a comprehensive risk management system for risk detection, risk assessment and risk minimization for all products.
    • Integral member of safety signaling committee and potentially other internal multi-disciplinary teams as assigned.
    • Ensures Risk Management System and Risk Management Plans (marketed product and developmental) are compliant with US, EU and International regulations and standards including ICH and EU GVP.
    • Support any applicable regulatory submissions including Marketing Authorization Applications (MAA), New Drug Applications (NDA) and Biologic License Applications (BLA).
    • Manages safety related committees, including the Signaling Committee, Executive Safety Committee, and SERM team.
    • Oversight and Management of Empirica and Topics to ensure all safety signals are documented appropriately.
    • Directs and collaborates on the development of product specific Risk Evaluation and Mitigation Strategy (REMS) in the event needed.
    • Manages process related to the REMS delivery team and general oversight of REMS programs for Acadia products where a REMS would be required.
    • Oversight and collaboration with stakeholders for preparation of Periodic Benefit Risk Evaluation Reports (PBRERs) for marketed products. Ensure data analysis provided are accurate and support logical safety conclusions.
    • Ensure sound safety analysis and responses to regulatory query as applicable, including in response to PBRER assessment report.
    • Directs and collaborates on the development of Risk Management Plans (RMPs/dRMPs), as required for Acadia's marketed and investigational products.
    • Assure successful completion of any future RMP commitments including post-authorization safety studies (PASS) and measuring the effectiveness of any risk minimization strategies.
    • Directs and collaborates on the production of Safety Discussion Documents (SDDs) in collaboration with Safety Physicians to assess and track safety signals.
    • Functions as a subject matter expert internal to DSP for epidemiology and provides in-house epidemiology expertise to other departments upon request.
    • Partners with Clinical Development and Medical Affairs teams in clinical trial planning regarding creation and conduct of risk management strategies utilizing pharmacoepidemiology research techniques (as applicable).
    • Provides estimates of incidence and prevalence of health conditions, disease progression and disease-specific risk factors.
    • Responsible for analysis of safety data requests from Health Authorities in collaboration with safety physicians.
    • Participates in cross functional teams and provides risk management and epidemiologic input, as needed.
    • Authors epidemiology relevant information and/or reports for submission to health authorities as required, and provide support for manuscripts for publication.
    • Provides epidemiologic consultation on the identification and assessment of safety risks, safety data interpretation as well as observational study and registry design, as needed.
    • Consults with safety systems programmers in the development of standard adverse event and tables generated for signal detection.
    • Draft SOPs and work instructions related to risk management, epidemiology and signal detection.
    • Collaborate with Clinical Development, Medical Affairs and others to design, implement, and publish study results.
    • Other duties may be assigned.

    Education/Experience/Skills

    Master's Degree in Public Health or related field required. Targeting 10 years of progressive applied epidemiology experience in a regulated biotechnology or pharmaceutical industries required or PhD with 4 years of progressive applied epidemiology experience in a regulated biotech or pharmaceutical industries. Prior experience with Drug Safety and Risk Management strongly preferred. An equivalent combination of relevant education and experience may be considered.

    Key Skills:

    • Experience in regulatory requirements and guidelines pertaining to Drug Safety and Pharmacovigilance are required.
    • Proficiency in performing data mining activities for analysis of safety data.
    • Experience with publishing original research in peer-reviewed journals and formal presentations at scientific meetings preferred.
    • Must be proficient in MS Office Suite.
    • Proficiency with standard desktop and pharmacovigilance computing programs such as Argus and Arisg preferred.
    • Proficiency with Empirica/Topics, Spotfire or other signal management tools preferred.
    • Excellent written and oral communications. Ability to effectively communicate (verbal and written) and defend findings and recommended strategies and activities to address these findings.
    • Ability to prioritize and organize work to meet deadlines.
    • Excellent project and time management as well as strategic planning skills.
    • Ability to work independently as well as in a team environment.
    • Ability to serve on multiple interdepartmental teams and to act as a team leader when appropriate.
    • Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environment.

    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 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

    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 or contact us at or .

    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 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.


    ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity


     

  • 14 Days Ago

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Business Analyst - Risk management
  • Datasys Consulting & Software Inc
  • Princeton, NJ FULL_TIME,CONTRACTOR
  • Title: Business Analyst -Must have strong Exp. in Risk management in the Banking/Financial domain (IF not please don't response or share the profile & excuse us) Location: NJ (Hybrid) Locals prefered ...
  • 10 Days Ago

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Insurance Risk Management Specialist
  • StoneMor Inc.
  • Bensalem, PA FULL_TIME
  • StoneMor is hiring an experienced Insurance Risk Management Specialist to join its corporate Legal team. This role will be responsible for overseeing and managing all property and liability claims for...
  • Just Posted

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HR Risk Management Specialist
  • Oaks Integrated Care
  • Mount Holly, NJ FULL_TIME
  • Join our team today and immerse yourself in a rewarding career for years to come! As the HR Risk Management Specialist you will be working in an office based setting within our HR department located i...
  • 22 Days Ago

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Risk Management Graduate Rotational Analyst
  • NRG Energy
  • Princeton, NJ FULL_TIME
  • At NRG, we're bringing the power of energy to people and organizations by putting customers at the center of everything we do. We generate electricity and provide energy solutions and natural gas to m...
  • 5 Days Ago

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Commercial Lines Customer Service Representative (CSR)
  • Nistar Risk Management NJ LLC qualified by...
  • Trenton, NJ FULL_TIME
  • Nistar is a fast growing Property & Casualty insurance brokerage placing various insurance policies for all different types of businesses. Nistar’s creativity and client-first approach has enabled us ...
  • 10 Days Ago

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0 Risk Management Director jobs found in Trenton, NJ area

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Senior Director, I&T Risk Management and Compliance
  • CSL
  • King Of Prussia, PA
  • The Opportunity The Senior Director I&T Risk and Compliance Management Services for CSL's technology function (I&T), dev...
  • 3/18/2024 12:00:00 AM

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Director, Quality and Risk Management
  • Haven Behavioral Healthcare
  • Philadelphia, PA
  • Quality & Risk Management Director About Haven Behavioral Hospital of Philadelphia Haven Behavioral Hospital of Philadel...
  • 3/17/2024 12:00:00 AM

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Manager, Portfolio Management
  • Nonprofit Finance Fund
  • Philadelphia, PA
  • Position Reports to: Director, Portfolio Management Location: Preference is for the position to be in commutable distanc...
  • 3/17/2024 12:00:00 AM

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Executive Director
  • Sunrise Senior Living
  • Morrisville, PA
  • : Sunrise Senior Living was again certified as a Great Place to Work by Activated Insights. This is the 6th time Sunrise...
  • 3/17/2024 12:00:00 AM

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Code Compliance Associate
  • Edgewood Properties
  • Piscataway, NJ
  • Overview: Since its founding in 1992, Edgewood Properties has established itself as a leading real estate development an...
  • 3/16/2024 12:00:00 AM

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Audit Senior Manager (Remote)
  • CBRE
  • Trenton, NJ
  • Audit Senior Manager (Remote) Job ID 152590 Posted 01-Feb-2024 Service line Corporate Segment Role type Full-time Areas ...
  • 3/16/2024 12:00:00 AM

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Solutions Director- Northeast Remote
  • CBRE
  • Trenton, NJ
  • Solutions Director- Northeast Remote Job ID 147965 Posted 11-Mar-2024 Service line GWS Segment Role type Full-time Areas...
  • 3/14/2024 12:00:00 AM

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LPN Med Care Manager
  • Sunrise Senior Living
  • Yardley, PA
  • Overview The LPN Medication Care Manager is responsible for providing the highest degree of quality care and services by...
  • 3/5/2024 12:00:00 AM

According to the United States Census Bureau, the city had a total area of 8.155 square miles (21.122 km2), including 7.648 square miles (19.809 km2) of land and 0.507 square mile (1.313 km2) of water (6.21%). Several bridges across the Delaware River – the Trenton–Morrisville Toll Bridge, Lower Trenton Bridge and Calhoun Street Bridge – connect Trenton to Morrisville, Pennsylvania, all of which are operated by the Delaware River Joint Toll Bridge Commission. Trenton is located near the exact geographic center of the state, which is 5 miles (8.0 km) located southeast of Trenton. The city is so...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Risk Management Director jobs
$175,714 to $237,378
Trenton, New Jersey area prices
were up 1.5% from a year ago

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