Careers

Asahi Kasei Pharma America (AKP America) is actively hiring new employees in the Boston area to support its product development efforts for ART123. AKP America offers a competitive salary and benefits, a stimulating environment that values teamwork, and the opportunity and expectation for individual excellence.

Asahi Kasei Pharma America Corporation is an Equal Opportunity Employer. Pre-employment background check and drug testing required.

Current Openings

Contracts Associate

Asahi Kasei Pharma America (AKPA) is recruiting for a Contracts Associate.  This newly created role offers the qualified candidate an opportunity to contribute to overall success and efficiency of the Alliance Management function within AKPA.

The Contracts Associate will be responsible for updating and maintaining contracts within our contracts tracking system as well as following up on the status of contracts under negotiation between parties.  He/she will also manage the internal signature control process in addition to preparing and troubleshooting global investigator payment reports.

This position operates in an environment that demands strong attention to detail, as well as strong organization, prioritization and problem solving skills.  A basic understanding of the clinical contracting process with sites and vendors is also required.

The Contracts Associate will work closely with the Manager of Clinical Contracts and our Director of Alliance Management on a day to day basis and will work with varying levels of independence on special projects/requests as appropriate.  To succeed in this role, you must have the ability to prepare and analyze detailed financial reports. You will assist in the review of contracted budget assumptions vs. actuals expenditures troubleshoot invoices, and follow up directly with clinical sites and/or vendors to ensure accurate and timely payment.  A strong professional presence along with a high level of professional maturity is required as you will interact with company senior management, principal investigators and vendors.

Experience and Qualifications

  • Minimum of 2 years’ experience in a clinical research/pharmaceutical environment in a budgeting, finance or contracts management function.
  • Bachelor’s Degree required. Business, finance or science focus preferred.
  • Experience with Clinical Trial Management System is highly desirable.
  • Able to work constructively in a matrix environment.
  • Self-motivated, pro-active with strong technical skills in all MS Office Suite programs. 

Temporary Contract Manager

Asahi Kasei Pharma America is looking to hire a temporary/contract Manager of Clinical Contracts to provide coverage during an employee LOA.  In this role the qualified candidate would be responsible for providing full-cycle contractual management of a portfolio of the firm’s contracts. Versatility, detail orientation and the ability to adapt in support of strategic priorities is fundamental to this role.

RESPONSIBILITIES: 

  • Facilitate timely contract review by disseminating information regarding contract status, compliance, and modifications to internal and external contacts
  • Ensure contracts are appropriate, equitable and enforceable
  • Maintain accurate contractual records, meet reporting deadlines and document significant events
  • Review contractual obligations in conjunction with Alliance Management department colleagues and Operations staff
  • Notify vendors/partners/subcontractors/sites formally, where issues/special circumstances or breaches of contract have taken place and ensure issues or problems are properly closed/resolved.
  • Monitor the vendor and site progress and performance to ensure goods and services conform to the contract requirements
  • Authorize payments consistent with assigned vendor or site contract terms
  • Resolve disputes in a timely manner
  • Assist and work with Director Alliance Management and Manager Clinical Contracts on special projects as needed

QUALIFICATIONS: 

  • BS in business, business administration or finance, an advanced degree or contract management certification preferred
  • At least five years of relevant experience with a strong understanding of the contract process for phases 1-4 clinical trials
  • Knowledge of federal and state laws desirable
  • Ability to remain productive while working independently.
  • Ability to work independently while interacting and influencing the Project Team
  • Impeccable writing skills; effective communication skills
  • Sound experience as a Contracts Administrator within the pharma, biotech or CRO industry is required
  • Excellent organizational skills, ability to work independently, assess priorities paying attention to detail under tight deadlines and heavy workloads
  • Advanced proficiency in Excel, MS Word and Power Point

Senior Drug Safety/Pharmacovigilance Specialist

The Senior Drug Safety/Pharmacovigilance Specialist will be responsible for case processing of serious adverse events for clinical trial and marketed products.  We will require the qualified candidate to utilize their medical background to write comprehensive case narratives for complex clinical cases in addition to interacting with study sites and CRO partners to obtain missing information.  We utilize the ARISg safety database and this role will enter case information into the database as needed.  Familiarity with ARISg is a plus.

Additionally, the Senior Drug Safety/Pharmacovigilance Specialist will assist with SUSAR regulatory submissions as well as periodic reporting including DSUR’s.  This role will also review and QC cases processed by other staff members and participate in the development of protocols, investigator brochures, safety forms and other documents.

This position operates in an environment that demands strong attention to detail, as well as strong organization, prioritization and problem solving skills.

Experience and Qualifications

  • Healthcare related education (nursing is ideal)
  • 2+ years of experience in a clinical setting
  • Able to work constructively in a matrix environment.
  • 3+ years of experience with safety case management including:
    • Safety database(s)
    • MedDRA/WhoDrug coding
    • Narrative writing – complex clinical cases (critical care, oncology)
    • Query generation
    • SAE reconciliation
  • Self-motivated, pro-active with strong technical skills in all MS Office Suite programs.
  • Working knowledge of US and global clinical trial safety regulatory reporting requirements.

Agency Notice

Asahi Kasei Pharma America (AKP America) does not accept unsolicited resumes from any third-party recruiters, agencies or individuals. Any such third party recruiters, agencies or individuals seeking to work with AKP America must first contact the staffing group at careers@akpamerica.com. Only approved staffing vendors will be allowed to provide services to AKP America. Unsolicited resumes will be deemed the property of AKP America to follow up with as it sees applicable and no fee will be paid in the event the candidate is hired as a result of the referral or by other means. Submission of unsolicited resumes does not create any implied obligation on the part of AKP America.