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Cmc Program Manager Jobs in Michigan (NOW HIRING)

MA/LPN - CMC

Sault Sainte Marie, MI ยท On-site

$24.50 - $33.25/hr

MAPS, MCIR Practice Management, Electronic Medical Records, LIS, Emageon, dictation systems, and any other necessary programs to assist providers and staff. * Demonstrates critical thinking for ...

MA/LPN - CMC

Sault Sainte Marie, MI ยท On-site

$23 - $31/hr

MAPS, MCIR Practice Management, Electronic Medical Records, LIS, Emageon, dictation systems, and any other necessary programs to assist providers and staff. * Demonstrates critical thinking for ...

Showing results 41-57

Cmc Program Manager information

What is a CMC Program Manager?

CMC Program Managers are professionals responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of pharmaceutical or biotechnology product development. They coordinate cross-functional teams to ensure that drug development activities related to product formulation, manufacturing, quality, and regulatory submissions are completed on time and within budget. Their role is crucial in advancing products through clinical development to commercialization while ensuring compliance with global regulatory requirements.

What are the key skills and qualifications needed to thrive as a CMC Program Manager?

To thrive as a CMC Program Manager, you need expertise in chemistry, manufacturing, and controls (CMC), project management experience, and an advanced degree in life sciences or a related field. Familiarity with regulatory submission systems, quality management tools, and certifications such as PMP or Six Sigma are highly valued. Strong leadership, cross-functional communication, and problem-solving skills help manage diverse teams and complex projects effectively. These skills ensure the successful development, regulatory compliance, and timely delivery of pharmaceutical products.

What are some typical challenges a CMC Program Manager faces when coordinating cross-functional teams?

A CMC Program Manager often encounters challenges in aligning the goals and timelines of diverse teams such as process development, analytical, regulatory, and manufacturing. Communication gaps and shifting priorities can complicate project execution, especially when managing external partners or contract manufacturing organizations. Proactive stakeholder engagement and clear documentation are essential to ensure that everyone remains on track and regulatory requirements are met. Successfully navigating these complexities is key to advancing products efficiently through the development pipeline.

What is the difference between Cmc Program Manager vs Cmc Project Manager?

AspectCmc Program ManagerCmc Project Manager
CredentialsTypically requires a Bachelor's degree in life sciences, engineering, or related field; often certifications like PMP or PgMPUsually holds a Bachelor's degree in a relevant field; PMP certification is common
Work EnvironmentOversees multiple projects within a program, coordinating cross-project activities in biotech or pharma industriesManages individual projects, focusing on specific deliverables within the CMC scope
Employer & IndustryPharmaceutical, biotech, or life sciences companies managing complex product developmentSimilar industry, often within the same companies, focusing on specific project execution

The Cmc Program Manager oversees multiple related projects, ensuring alignment with strategic goals, while the Cmc Project Manager focuses on executing individual projects within the CMC domain. Both roles require similar credentials and work in the same industry, but differ in scope and responsibilities.

What are popular job titles related to Cmc Program Manager jobs in Michigan?

For Cmc Program Manager jobs in Michigan, the most frequently searched job titles are:

What cities in Michigan are hiring for Cmc Program Manager jobs?

Cities in Michigan with the most Cmc Program Manager job openings:

MA/LPN - CMC

My Michigan Health

Sault Sainte Marie, MI โ€ข On-site

$24.50 - $33.25/hr

Other

Posted 19 days ago


Job description

Job Title

Under direct supervision of the provider, will be responsible for patient assessment and care, and maintaining appropriate documentation. This position must have basic knowledge of specialty and/or primary care and able to assess, plan, implement and evaluate care for patients. This position is responsible for coordinating care to assure high quality, compassionate patient care is provided. They will maintain and oversee patients at the office locations and will act as the liaison with other organizations and departments. This position may be required to order all medical, pharmacy supplies, and office supplies to manage patient care. They will assure compliance with all the policies/procedures of MyMichigan Health and follow Occupational safety and Health Administration (OSHA) guidelines, Clinical laboratory Improvement Amendments (CLIA) regulations, and all appropriate regulatory agencies. They will coordinate with and train any new employees, students and float staff as required. The clinical person will provide patient education, assist with specialty care modalities, symptom management, be available for emergencies, monitor for compliance and the effects of care management with high risk patients, educate on prescriptions and teach the patient and family the reasons for the medication and side effects, coordinate and ensure continuity of care with other providers. Also, may perform general office duties (keyboarding, filing, telephone, computer and office equipment) as needed. The expectations outlined in this job description may vary slightly depending on the practice in which you are assigned. Your immediate supervisor will be able to clarify your responsibilities for you.

Responsibilities

(30%) Triages all calls, schedules daily urgent/emergent add-ons, receives and relays test results. Supports, directs and refers patients for consults and/or testing and insurance pre-certification and documentation.

(30%) Greets patients and/or family, performs routine pre-examination procedures including vital signs, assessing and recording objective and subjective data concerning presenting condition. Updates and maintains an accurate patient record by performing but not limited to, orders reconciliation, secure messaging (if available) and other tasks as assigned. Performs medication reconciliation, enters allergy reaction type, processes refills within the scope of their certification.

(20%) Assists provider with examinations and procedures.

(20%) Prepares and cleans the patient area, sets up equipment, cleans and facilitates room set up after a procedure. Disposes of contaminated supplies and sterilizes medical instruments.

Other duties and responsibilities:

  • Provides complete patient assessment as indicated within the scope of the practice.
  • Performs patient care measures including injections, minor dressing changes, and obtaining blood specimens. In some practices may be required to, demonstrate competency to assist with procedures such as, but not limited to electrocardiogram (EKG), Pulmonary Function Test (PFT), Ankle Brachial Pressure Index (ABI), and Non-stress Test (NST).
  • Assists in maintaining a clean and safe environment for patients and co-workers. If applicable, maybe required to travel to satellite clinics.
  • Understands necessary computer functions in the office setting: MAPS, MCIR Practice Management, Electronic Medical Records, LIS, Emageon, dictation systems, and any other necessary programs to assist providers and staff.
  • Demonstrates critical thinking for patient management.
  • Maintains a high level of confidentiality and ensures patients rights in accordance with proper procedures and in compliance with HIPAA (Health Insurance Portability Accountability Act).
  • May be asked to perform clerical duties filing out insurance forms, correspondence, arranging hospital admission, answering the telephone, updating/filing patients medical records. Orders supplies and medications.
  • Maintains a system for accurately documenting and coding, in the medical record as appropriate and per policy. Participate in annual review for quality and completeness as necessary.
  • Provides for the age specific needs of the population served according to department standards and policies/procedures as evidenced by observation, documentation and peer feedback.
  • Performs other related duties as assigned.
  • MyMichigan Health is a technology driven organization and employees need to demonstrate competency in Microsoft Windows. An employee may be required to participate in further learning opportunities offered by MyMichigan Health.
Certifications and Licensures

Credential: BLS: Basic Life Support Equivalent Experience: Within 3 months of hire or transfer

Qualification Source: AHA

Credential: MA CERT: Medical Assistant Equivalent Experience: As required by Medicare and Medicaid Services (CMS) to be employed through MyMichigan Health all Medical Assistants must possess one of the following active certification/licensure: Registered Medical Assistant (RMA) through American Medical Technologist (AMT)Certified Medical Assistant (CMA) through American Association of Medical Assistants (AAMA)OR equivalent Medical Assistant Credential such as (Certified Clinical Medical Assistant CCMA, etc.).Prefer completion of a Medical Assistant program through an accredited organization. Medical First Responder, Emergency Medical Tech Basic/Specialist, or Paramedic though the State of Michigan. Registered Radiologic Technologist through American Registry of Radiologic Technologists (ARRT).

Credential: FINGERPRIN: Fingerprinting

Required Education

Education: High School Diploma or GED Equivalent Experience:

Other Information

Experience, training and skills:

Excellent interpersonal skills needed to communicate successfully with individuals and groups and interact with people at all levels to communicate ideas and concepts in a clear and understandable manner.

Mandatory Occupational Safety and Health Administration (OSHA) training must be done annually according to the Exposure Control Plan.

Knowledge of medical office policies, practices and procedures as normally acquired through three to five years working in the health care system or similar setting.

Previous experience in a physician clinic setting preferred.

Physical/Mental Requirements and Typical Working Conditions

Exposure to stressful situations, including those involving public contact, as well as, trauma, grief and death.

Able to wear personal protective equipment that includes latex materials or appropriate substitute if required for your position.

Is able to move freely about facility with or without an assisted device and must be able to perform the functions of the job as outlined in the job description.

Overall vision and hearing is necessary with or without assisted device(s).

Frequently required to sit/stand/walk for long periods of time. May require frequent postural changes such as stooping, kneeling or crouching.

Some exposure to blood borne pathogens and other potentially infectious material. Must follow MyMichigan Health bloodborne pathogen and TB testing as required.

Ability to handle multiple tasks, get along with others, work independently, regular and predictable attendance and ability to stay awake.

Overall dexterity is required including handling, reaching, grasping, fingering and feeling. May require repetition of these movements on a regular to frequent basis.

Physical Demand Level: Light. Must be able to occasionally (0-33% of the workday) lift or carry 11-20 lbs., frequently (34-66% of the workday) 10 lbs. and or Walk/Stand/Push/Pull of Arm/Leg controls.