About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
Additionally, please note that full vaccination for COVID-19 is a requirement for this position.Â Applicants may request a reasonable accommodation based on disability and/or religion reasons. BioLife/Takeda reserves the right to deny such requests when appropriate.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
Supports BioLife Medical Affairs Programs to ensure safety of the plasmapheresis donors and the collection of the high-quality plasma products. Be responsible for Center Physician's processes by addressing questions on hiring medical staff and Center Physician contracts (e.g. MSA, SOW, and additional SOW) to include timely payments (e.g. recurring payments and one off payments) by entering into the Takeda Financial tools. Assist in assuring that all medical/technical activities (e.g. center physicians) are performed in accordance with federal regulations and BioLife Standard Operating Procedures (SOPs) within the US.
Facility Support (60%)
Assist with and respond to BioLife Plasma Center Management questions with respect to Medical Affairs SOPs and processes in direct cooperation with the Lead â Medical Affairs.
Monitor and perform the administration of Center Physician contracts â new and renewal.
Corrective and Preventative Actions (10%)
Be available to provide support or provide responses for issues directly responsible during audits and/or regulatory inspections.
Assist in the investigation of errors (e.g. TrackWise), including corrective and preventative actions, if applicable
Investigate Center Physician payment issues with Finance as needed.
Administrative Support (30%)
Assist Lead â Medical Affairs with investigations and data collection with respect to Medical Affairs processes.
Ensure Medical Affairs documentation â paper and digital â are updated and maintained in an orderly manner and in accordance with cGMP and GDP, including filing of doucments and facilitating access to documentation at all times.
Assist with the revision of Medical Affairs SOPs as they pertain to Center Physicians as necessary.
Support other BioLife departments such as Legal, EHS, Regulatory Affairs, Quality Assurance, Laboratory, Purchasing, and Marketing with medical requirements as needed.
Other duties and responsibilities as assigned
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Strong knowledge of cGMPs and GDPs
Knowledge of the Medical Affairs SOPs and other required documents
Detail-oriented with ability to detect errors in documentation
Strong written and verbal communication skills
Demonstrate proficiency in computer operations (e.g. Excel spreadsheets, PowerPoint presentations)
Be Results Oriented
Be An Excellent Manager of Self and Others
Putting the patient at the center
Building Trust with Society
Reinforcing our Reputation
Developing the business
Effective Coaching and Counseling Skills
Decision-making and Autonomy
Ability to handle multiple projects at a time and have strong attention to detail
Ability to make decisions based on past experiences, established practices, and procedures
Strong interpersonal skills
Demonstrate good communication and leadership ability
Assist Lead, Medical Affairs on a daily basis
Assist center management teams and personnel on a daily basis
Interact on a daily basis with plasma center employees by phone and written communication, as well as with Headquarters employees
Ability to work in a fast-paced, high-volume environment performing multiple tasks as part of a goal-oriented team
Provide feedback to management for potential issues noted or potential improvements
Be flexible and quick to respond to Center Physicians and Finance
Identify plasma units determined to be unsuitable for further manufacturing
Ensure all activities are performed in accordance with BioLife SOPs and federal and foreign regulatory guidance (e.g. FDA and EMA)
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:Â
Essential: High School Diploma or Associate degree with a major in Health Care such as Nursing, Physician Assistant, Clinical Laboratory or Medicine
Desired: Prior 2 years or more experience in Health Care environment with at lease one year experience in a plasmapheresis or apheresis program
Be willing to learn and assist in new opportunities as they arise within the department.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.