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.
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.
Director of Quality
Asahi Kasei Pharma America (AKPA) is searching for a qualified, high-impact individual to lead our Quality Department. The position will be based in our Waltham, MA corporate offices and will travel globally as needed to ensure that quality standards are being met. We are looking for a seasoned professional possessing the professional presence and confidence to strategize and implement programs that are compliant and leading edge.
The primary responsibility of our Director of Quality is to lead the QA Department by establishing complaint unified Global Quality Systems and serve as a leader for routine QA functions (i.e. audits, Regulatory Agencies inspections, issues documentation and resolutions. The qualified candidate must have “hands on” experience in the development of and management of Quality Systems and must also have extensive knowledge, understanding and proven application of quality tasks in drug development and marketed product manufacturing and release
- Oversee the operations of all global GMP, GCP and GLP activities
- Direct operations of Quality Assurance personnel; provide mentorship to direct reports and maintain clear communication on performance to direct reports
- Initiate and support continuous process improvement
- Release product
- Oversee, and manage documentation systems including but not limited to, change control, SOPs, protocols/reports, training records, job descriptions
- Oversee the development of a comprehensive global audit program
- Lead the implementation of a Quality System that will assure that products manufactured are in compliance with cGMPs, US and EMA regulations, and clinical research carried out is in compliance with the GCPs and SOPs
- Bachelor’s Degree required
- 5-10 years of hands on experience in a Quality organization within the pharmaceutical and/or biotechnology industries
- 5+ years hands on experience in managing Quality, and possess the ability to function effectively as a member of project teams with demonstration of superior leadership skills
- The candidate should have extensive knowledge of QA, CQA, QC, Regulatory Compliance and global requirements for Quality Systems
- Full understanding of the commercialization of products (drugs and biologics)- both in the US and EU
Director of Medical Affairs (North America)
Asahi Kasei Pharma America is recruiting for an experienced Director of Medical Affairs (North America) to support US enrollment efforts of the current and upcoming global Phase 3 Clinical Trial. This position can be based anywhere in the US. Specific responsibility for this role will be the scientific presentations, and identification and implementation of strategies and tactics that enhance enrollment activities at each of our partner-sites, while reporting into the VP of Medical Affairs in the US.
On a day-to-day basis you will work with members of the site team, as appropriate, to implement programmatic initiatives aimed at accelerating enrollment. You would be expected to travel significantly (75% of the time) to various North American clinical sites and hospitals, working with hospital personnel to expedite approval of clinical trial processes. You will also identify and work with external resources and vendors to ensure that their services/products provide maximum return to Asahi Kasei Pharma America and our site partners.
This is a high impact role with significant internal and external visibility. We need someone who can clearly articulate the value of the clinical program to medical personnel on scientific terms. It will be important to influence behaviors to get the desired results while partnering with site management to identify and eliminate items that result in enrollment delays. In addition to working on and solutioning site-specific issues, the Director of Medical Affairs, North America will also interface regularly with the Principle Investigator and other site personnel to strategize on future initiatives while ensuring current initiatives are completed and implemented appropriately. This is a brand new role that has the potential to significantly accelerate the career of the qualified candidate.
- Possess appropriate scientific acumen and clinical knowledge to be able to assess site or regional issues.
- Ideal candidate will have a demonstrated track record of identifying and resolving small and large operational challenges.
- Must be able to think like a clinician and implement like an entrepreneur.
- We require a minimum of a Bachelor’s degree but would prefer a background of PharmD or PhD, and MBA.
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 firstname.lastname@example.org. 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.