CMC Manager Job at Alliance Medical Ltd (Guildford)

Client Engagement Manager, CMC

Serve as a single point of contact for CCS (Connectivity Car Service) and Mobili...

Location

United States , Costa Mesa

Salary:

103170.00 - 158873.00 USD / Year

Hyundai AutoEver America

Expiration Date

Until further notice

Requirements

Bachelor's Degree or higher in a related field
5 + years of experience in a similar role such as client relationship/ key account management, preferably in the telematics, IT or automobile industry.
Consulting experience at a Big4 consulting company, highly desirable
Understanding of telematics services, fleet management, and connected vehicle solutions preferred.
Telecommunications experience preferred, with broad knowledge of various telecommunication products, services, networks, carriers, rate plans, contracts, and invoices
Ability to solve practical problems and deal with a variety of situations.
Ability to interpret difficult instructions, derive valid conclusions, and recommend reasonable courses of actions within the scope of the position.
Well organized with ability to pay close attention to details.
Strong interpersonal skills.
Able to collaborate effectively with cross-functional teams.

Job Responsibility

Serve as a single point of contact for CCS (Connectivity Car Service) and Mobility service-related inquiries and requests from clients and partners.
Facilitates and lead new service-related contract development / amendments with clients, HMG affiliates and partners.
Engage in all aspects of client and partner interactions, collaborate with the Procurement team to manage vendor contracts and relationships, creation/negotiation with client companies, coordinate with all internal departments for client proposal creation, and provide consulting service to client companies.
Lead various projects related to account management, client service, and partner management.
Create/manage customer pricing model align with company's strategic direction
Create/manage wireless usage forecast model based on new services and vehicle volume.
Manage subordinate Business Analysts, as applicable
Staying abreast of service implementation and business operation status, keep clients informed and stay up to date with their connectivity service status
Functions as a key advocate for Client Business Units (CBUs)
Serve as a single point of contact for connectivity service-related inquiries and requests from clients

Fulltime

CMC Project Management Specialist

Location

United States

Salary:

Not provided

Enveda

Expiration Date

Until further notice

Requirements

Experience with CMC project management in the biotech or pharma industry, specifically focusing on drug substance and drug product development
Experience leading cross-functional teams
Flexibility, adaptability, and resourcefulness
Willingness to work occasional early morning or late evening meetings to accommodate different time zones
Experience managing external CROs and CDMOs

Fulltime

Integrated Care Manager

Responsible for promoting continuity of care through a collaborative process tha...

Location

United States , Phoenix

Salary:

Not provided

Blue Cross Blue Shield of Arizona

Expiration Date

Until further notice

Requirements

2 year(s) of experience in full-time equivalent of direct clinical care to the consumer
Associate’s Degree in general field of study or Post High School Nursing Diploma or Master’s Degree in a behavioral health field of study (i.e., MSW, MA, MS, M.Ed.), Ph.D. or Psy.D
Active, current, and unrestricted license to practice in the State of Arizona (or an endorsement to work in Arizona) as a behavioral health professional such as LCSW, LPC, LISAC LMFT, or licensed psychologist (Psy.D. or Ph.D.), OR an active, current, and unrestricted license to practice nursing in either the State of Arizona or another state in the United States recognized by the Nursing Licensure Compact (NLC) as an RN
Within 4 years of hire as a Care Manager employee must hold a certification in case management from the following certifications
Certified Case Manager (CCM), Certified Disability Management Specialist (CDMS), Case Management Administrator, Certified (CMAC), Case Management Certified (CMC), Certified Rehabilitation Counselor (CRC), Certified Registered Rehabilitation Counselor (CRRC), Certified Occupational Health Nurse (COHN), Registered Nurse Case Manager (RN, C), or Registered Nurse Case Manager (RN,BC).

Job Responsibility

Assess and collect data related to the member from all care settings. Interview and collaborate with case-related providers, member and family to implement the care plan
Answer a diverse and high volume of health insurance related customer calls on a daily basis
Explain to customers a variety of information concerning the organization’s services, including but not limited to, contract benefits, changes in coverage, eligibility, claims, BCBSAZ programs, provider networks, etc
Analyze medical records and apply medical necessity criteria and benefit plan requirements to determine the appropriateness of benefit requests
Present status reports on all cases to the manager/supervisor and, when indicated, to the medical director
Consult and coordinate with various internal departments, external plans, providers, businesses, and government agencies to obtain information and ensure resolution of customer inquiries
Meet quality, quantity and timeliness standards to achieve individual and department performance goals as defined within the department guidelines
Maintain all standards in consideration of state, federal, BCBSAZ, URAC, and other accreditation requirements
Maintain complete and accurate records per department policy
Demonstrate ability to apply plan policies and procedures effectively

Fulltime

CMC Project Management Specialist

Join Enveda as a CMC Project Management Specialist in a remote capacity and help...

Location

United States

Salary:

95000.00 - 115000.00 USD / Year

Enveda

Expiration Date

Until further notice

Requirements

B.S./M.S./Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar degree
1-2+ years of CMC project management experience in biotech or pharma, with exposure to drug substance and drug product development
Ability to manage cross-functional projects and communicate technical details clearly
Experience working with external CROs and CDMOs

Job Responsibility

Lead cross-functional planning and execution of CMC development activities across drug substance and drug product
Partner with internal and external teams to define and track development strategies, timelines, and deliverables
Oversee and monitor external CRO and CDMO activities, including planning, communication, and batch execution timelines
Develop and manage detailed CMC project plans, ensuring timely delivery through proactive communication and follow-up

What we offer

90% Medical, Dental, Vision
401k Match
Flexible PTO
Adoption Assistance

Fulltime

Cmc project manager i eds

ICON is looking for a CMC Project Manager I to join our Accelerated Pharmaceutic...

Location

United States , San Antonio

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

A minimum of 1 year experience in clinical, laboratory or project management role
Background in project management, preferably in a pharmaceutical setting
Familiarity with GMP regulations and compliance requirements
Excellent communication and interpersonal skills
Ability to effectively manage resources and prioritize tasks to meet project deadlines
Detail-oriented with strong organizational and problem-solving abilities
Bachelor or advanced degree in a relevant scientific field preferred, e.g. medicinal chemistry, organic chemistry, pharmaceutical sciences

Job Responsibility

Lead and manage multiple CMC projects from early development through commercialization
Coordinate cross-functional teams, including Analytical, Formulation Development, Manufacturing, Regulatory, and Quality Assurance
Review and authoring of relevant method validation, pharmaceutical analysis, QC reports and other relevant GMP documentation and deliverables
Develop and maintain detailed project plans, timelines, and risk assessments
Ensure compliance with global regulatory requirements, including FDA, EMA, and ICH guidelines
Act as the primary liaison between clients, internal teams, and third-party vendors to ensure alignment and timely execution of project deliverables
Work with planning to ensure that appropriate resources are available to complete the study to timeline
Proactively identify and address potential project risks, implementing effective mitigation strategies
Provide clear, timely, and professional communication to stakeholders regarding project progress, milestones, and potential challenges
Monitor project budgets and resource allocation to ensure efficient and cost-effective project execution and draft change order budget when scope changes occur

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Regulatory CMC Project Manager

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management)
3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls)
Strong project management skills with a track record of managing complex projects and meeting deadlines
Excellent organizational and communication skills
Excellent time management abilities
Proficient in Microsoft Office Suite
Proven experience with project management software ie. Smartsheet
Strong communication and interpersonal skills
Ability to work collaboratively in a fast-paced, dynamic environment
Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones

Job Responsibility

Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions
Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements
Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed
Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards
Health Authority Engagement: Support the preparation of materials for health authority engagements

What we offer

Flexibility of working remotely
Part of a supportive and dynamic team
Supportive and inclusive environment
Opportunities for career growth
Flexible work arrangements
Diverse and global client exposure
Learn from experts

Senior Regulatory Associate

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD)
Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory Affairs CMC
Sound knowledge in natural sciences with a focus on biological/vaccines/small molecule medicinal products
Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia)
Strong regulatory CMC writing skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements
Knowledge in Good Manufacturing Practice or related areas would be highly regarded
A degree in Regulatory Affairs is advantageous

Job Responsibility

Author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs, including responses to Health Authority requests
Prepare and review CMC packages
Support GMP submissions
Manage change control assessments
Ensure compliance with regulatory requirements across multiple regions
Conduct and deliver high quality, on time CMC regulatory activities, including compliant management of all internal tools and client systems
Author Administrative and CMC regulatory documents/deliverables and collaborate with project SMEs and client stakeholders to prepare submission packages
Full management of CMC submissions (i.e. planning, submission package compilation, RtQ preparation, Spontaneous HA queries, etc.)
General submission coordination: Submissions planning (tracker update, timelines agreement with LRA and GRA-CMC, recurrent meetings with LRAs), create submission binders and Global Content List/Submission Content Plans, coordinate the publishing aspect, review of eCTD sequences
Act as main GRA point of contact for LRAs and other stakeholders (i.e. for responding to any queries)

What we offer

Flexible work arrangements
Opportunities for career growth
Diverse and global client exposure
Learn from experts
Supportive and inclusive environment

Senior Manager, CMC Operations

Reporting to the Senior Director, CMC Operations, the Senior Manager, CMC Operat...

Location

United States , Waltham

Salary:

136000.00 - 170000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

8+ years of experience in pharmaceutical drug development and track record of success supporting multiple projects or programs simultaneously
Excellent communication/presentation skills and proficiency in Smartsheet software
Proven track record of creativity, problem solving, and productivity
Demonstrated success working in interdisciplinary and cross-functional teams
Comfortable working in a dynamic, interactive, fast-paced, and entrepreneurial environment
Bachelor’s degree in a scientific discipline

Job Responsibility

Drive Tech Ops, Quality, and Regulatory teams to ensure project priorities are clearly documented and communicated
Manage the CMC vendors to ensure all work is occurring according to the contracted scope, schedule, and budget
Responsible for the tracking of program budget and finances for CMC functions
Create and independently maintain project communication tools, such as CMC team meeting minutes, action tracking, and timeline plans
Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant stakeholders
Define and monitor progress on deliverables and provide timely updates to key stakeholders on project target dates and progress against goals
Actively manage relationships and communication between Kailera and external partners or service providers as required

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

CMC Manager

Alliance Medical Ltd

Location:
United Kingdom , Guildford

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 03, 2026

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Alliance Medical Ltd

Location:United Kingdom , Guildford

Category:Research and Development

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Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:March 03, 2026

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