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Technical & Quality Manager

Cleveland, OH | Chemicals / Manufacturing

We’re seeking a Technical & Quality Manager to lead quality systems, regulatory compliance, and technical oversight for our chemical products. This role partners closely with Operations, Legal, Marketing, and Sales to ensure products are compliant, high‑quality, and market‑ready—while driving continuous improvement and innovation.

What You’ll Do

• Own and continuously improve the Quality Management System (QMS)
• Lead quality control processes, testing protocols, audits, and CAPA activities
• Serve as the primary point of contact for regulatory compliance (OSHA HazCom, EPA, TSCA, VOC, state regulations)
• Monitor regulatory changes and assess impact to products, formulations, and labeling
• Author and maintain Safety Data Sheets (SDS), Technical Data Sheets (TDS), and compliance documentation
• Ensure accurate product labeling and hazard communication
• Support new product development, formulation improvements, and scale‑up from lab to production
• Provide technical support to internal teams and customers
• Interface with regulatory agencies, auditors, consultants, and customers as needed

What You Bring

• Bachelor’s degree in Chemistry, Chemical Engineering, or related field (advanced degree a plus)
• 5+ years of experience in quality, regulatory, or technical roles within chemical manufacturing
• Strong working knowledge of manufacturing processes, quality systems, and chemical interactions
• Experience with SDS authoring, regulatory documentation, and audit support
• Hands‑on familiarity with lab instrumentation (e.g., pH meters, viscometers, scales)
• Excellent analytical, organizational, and problem‑solving skills
• Ability to communicate clearly with both technical and non‑technical audiences

Preferred Experience

• Industrial wipes, cleaners, sealants, adhesives, or similar chemical products
• ISO‑based quality systems
• VOC and state‑level regulatory compliance (e.g., CARB)
• UL, CSA, or NSF exposure

Why This Role

This is a high‑impact role for someone who enjoys balancing regulatory rigor, quality excellence, and technical problem‑solving—while working cross‑functionally to support both operations and growth.

Benefits Include

• 401(k) match
• Medical, dental, and vision insurance
• Short and long-term disability coverage
• Life and accidental insurance
• 10 paid holidays starting immediately
• Generous PTO plan based on years of service
• Tuition reimbursement and a variety of learning, coaching, and training opportunities to foster individual growth

Company Description

F.D.R. Consulting Group brings over 20 years of expertise in legal recruitment, specializing in job placements for individual attorneys, practice groups, and facilitating mergers for law firms and corporations.

Role Description

This is a full-time on-site role for a Patent Attorney/Agent/Tech PhD with a background in Biotechnology or Chemistry. The role involves drafting and prosecuting patent applications, conducting patentability, freedom-to-operate, invalidity search/analysis; analyzing technical documents to assist with patent prosecution, counseling, post-grant proceedings, and litigations. Patent Attorneys, Agents and Technology Specialists can be considered in Boston, NY or DC.

Qualifications

• Experience in drafting and prosecuting patent applications and patent preparation
• Strong knowledge of Patent Law and patentability
• Advanced degree (Ph.D. preferred) in Biotechnology, Chemistry, or a related field
• Attorneys should have admission to a Bar and the USPTO
• Patent Agents should be registered USPTO
• Excellent communication skills
• Prior experience in a legal or intellectual property role

About the Role

Kolon TissueGene, Inc. is seeking an Associate Director, Clinical Quality Assurance responsible for maintaining the Quality Management System and other programs to support Clinical Operations and commercialization of biopharmaceutical products. This role will ensure that all Clinical QA details are managed efficiently and exhibit continuous improvement.

Reporting to the Head of Quality Assurance, this role will support Inspection Readiness, regulatory Inspections, Quality policies and procedures. The Associate Director, Quality Assurance will work with Clinical Operations and Regulatory Affairs to ensure adherence to KTG policies, programs, and procedures in support of commercialization. A fundamental measure of success for the position will be a successful BLA Approval Inspection and launch of commercialized drug products.

This position is based on-site at our Rockville, Maryland headquarters.

Key Responsibilities

Quality Systems Leadership

• Lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), including Change Control, Deviations, Complaints, Vendor Management, and Audit programs.
• Ensure quality processes and systems meet FDA and global regulatory expectations.
• Oversee electronic quality systems supporting training management and GxP document control.

Clinical Quality Oversight

• Drive the GCP Quality strategy across clinical development programs.
• Provide independent Quality oversight of Clinical Operations to ensure compliance with regulatory and internal quality requirements.
• Review and approve clinical and nonclinical documentation, including protocols, amendments, deviations, CAPAs, and change controls.
• Oversee the development and maintenance of Clinical SOPs.
• Manage training qualification and compliance for Clinical Operations and Data Management teams.

Inspection Readiness & Regulatory Support

• Lead inspection readiness activities across clinical programs.
• Serve as a lead representative during FDA inspections and vendor audits.
• Support regulatory interactions including GCP inspections, Pre-Approval/BLA inspections, and investigator site inspections.
• Ensure clinical programs maintain inspection-ready documentation and processes.

Risk Management & Continuous Improvement

• Lead quality risk management initiatives, facilitating risk assessments and implementing mitigation strategies.
• Identify opportunities for process improvements and quality system enhancements.
• Ensure quality initiatives and projects are properly resourced and executed within established timelines.

Leadership & Team Development

• Build and lead a high-performing Clinical QA team.
• Manage hiring, coaching, and development of Quality staff.
• Promote a culture of quality, compliance, and “first-time-right” execution.
• Ensure team members maintain appropriate training and qualifications.

Operational & Strategic Support

• Develop and manage Quality department timelines, budgets, and resource planning.
• Provide regular updates to senior leadership and project teams regarding Clinical QA activities and inspection readiness.
• Manage Quality vendor relationships and contracts, including quality consultants and electronic quality system providers.

Qualifications

Education

• Bachelor’s degree in Biological Sciences, Life Sciences, Physical Sciences, or a related discipline required
• Advanced degree (M.S., Ph.D., or equivalent) preferred

Experience

• 10+ years of experience in the biopharmaceutical industry, with a minimum of 8 years demonstrated experience of direct interaction with FDA and other regulatory agencies through GCP, Pre-Approval/BLA Inspections, and Investigator Site inspections.
• 6+ years of leadership experience in Clinical Quality Assurance roles
• Experience developing, implementing, and maintaining Quality Management Systems (QMS)
• Experience working with Clinical Operations and Regulatory Affairs teams in regulated development environments
• Experience in cell and gene therapy programs or advanced biologics preferred

Core Competencies

• Strong knowledge of ICH guidelines, FDA regulations, and GCP compliance requirements
• Expertise in Quality Management Systems, including change control, deviations, CAPA, audits, and vendor oversight
• Ability to maintain independent Quality oversight of Clinical Operations
• Strong leadership, organizational, and team development skills
• Excellent written and verbal communication skills
• Strong problem-solving and risk management capabilities
• Demonstrated commitment to quality, compliance, and continuous improvement

Work Environment & Physical Requirements

• On-site position with up to approximately 20% travel.
• Extensive computer and keyboard use involving repetitive motion.
• Regular telephone and in-person communication.
• Ability to lift up to 25 pounds, with or without reasonable accommodation.

Kolon TissueGene will provide reasonable accommodations for qualified individuals with disabilities in accordance with the Americans with Disabilities Act (ADA) and applicable state law.

Why Join Kolon TissueGene?

Kolon TissueGene is advancing innovative regenerative cell and gene therapies designed to address the root causes of disease. As a member of our Bioinformatics team, you will contribute directly to the scientific rigor and data integrity that enable safe, effective therapies to reach patients.

About Us

Kolon TissueGene, Inc. (KTG) is a clinical-stage biopharmaceutical company developing first-in-class regenerative therapies, including TG-C for osteoarthritis of the knee. We are building a mission-driven team committed to scientific excellence, regulatory compliance, and patient impact.

Benefits Highlights:

• Onsite yet Flexible work schedules
• Premium-free global health insurance (50% dependent coverage)
• 401(k) with immediate eligibility
• Long-term incentive bonuses
• On-site gym & wellness perks
• Extra PTO accrual every year
• Global and local training opportunities
• Visa sponsorship available for qualified candidates

Equal Opportunity Employer

Kolon TissueGene, Inc. is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration without regard to race, color, religion, gender, identity, sexual orientation, national origin, disability, or veteran status.

Apply today to shape the future of regenerative medicine with precision, rigor, and purpos

Industry: Pharmaceuticals

Title: Quality Control Analyst III

Job ID: NORT000022

Location: Norton, MA

Duration: 10 months contract (+Possibility of extension)

This position is onsite and will be primarily located in Norton, MA. There may be occasional responsibilities at a secondary location in Cambridge, MA.

Overview

The Quality Control Operations (QCO) LEQ Analyst III plays a crucial role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization. This position is responsible for supporting and executing laboratory equipment qualification activities in compliance with USP and applicable regulatory requirements. This role ensures laboratory instruments are fit for intended use throughout their lifecycle and supports data integrity, compliance, and continuous improvement within the laboratory quality system. By ensuring these critical activities are executed with precision, the LEQ Analyst III significantly contributes to routine laboratory operations, thereby enhancing the overall efficiency and effectiveness of the QC functions .

Key Responsibilities (including but not limited to):

• Perform and support laboratory equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with USP .
• Classify laboratory instruments (Groups A, B, and C) and determine appropriate qualification strategies.
• Review and approve qualification protocols, test scripts, and reports.
• Support equipment lifecycle management, including calibration, maintenance, requalification, and change control.
• Review vendor documentation (URS, manuals, certificates) to support qualification and compliance.
• Investigate and document deviations, discrepancies, and out-of-tolerance events related to equipment performance.
• Ensure qualification activities comply with internal SOPs, cGMP, data integrity principles, and regulatory expectations (e.g., FDA, EMA).
• Collaborate with laboratory staff, quality assurance, validation, facilities, and vendors to resolve equipment-related issues.
• Maintain accurate and complete documentation in electronic quality systems.
• Support audits and inspections by providing qualification documentation and technical explanations as needed.
• Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance.
• Actively participate in continuous improvement efforts by identifying and suggesting enhancements to laboratory processes, particularly those related to efficiency and reliability.
• Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.

Qualifications

• B.S. in chemistry, biology, or biochemistry, or related scientific field ;
• Pharmaceutical/Biotech industry experience with 6-10 years in a GMP Quality Control function or equivalent, relevant industry experience
• Hands-on experience with laboratory equipment qualification in a regulated environment.
• Strong working knowledge of USP and laboratory instrument lifecycle management.
• Familiarity with cGMP, GLP, and data integrity requirements.
• Experience with common laboratory instruments (e.g., HPLC, GC, balances, dissolution, UV/Vis, pH meters, spectrometers).
• Ability to write clear, compliant technical documentation.
• Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously
• Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment
• Experience in pharmaceutical, biotech, or contract testing laboratory environments.
• Exposure to computerized systems validation (CSV) as it relates to laboratory instruments.
• Familiarity with calibration and maintenance programs.
• Experience supporting regulatory inspections or internal audits.

Located in Thousand Oaks, California, 20BLOC is a small privately held development-stage biopharmaceutical company, driven by a mission to create breakthrough protein-based drugs to save lives. Our lead product is an innovative solution to provide oxygen to tissues. Check us out at

We are looking for a motivated and hands-on Head of Manufacturing to join our team.

How you will add value to 20BLOC

The Head of Manufacturing will lead our manufacturing and MSAT teams as we transition from pre-clinical manufacturing and move into our newly built cGMP production facility. This role is responsible for the management and day-to-day oversight of our manufacturing and MSAT functions and will provide strategic direction to the business as we continue to scale and plan for future production needs. The Head of Manufacturing works closely with quality, supply chain, R&D, and other cross-functional teams to ensure product quality, data integrity, and regulatory compliance.

Key Responsibilities

Manufacturing and MSAT Leadership

• Lead Production and MSAT as tightly integrated functions, owning day-to-day manufacturing execution and technical decision-making as the company transitions from pre-clinical operations into a new cGMP manufacturing facility
• Own day-to-day execution of manufacturing operations ensuring safe, compliant, and reliable batch execution
• Establish clear accountability for process ownership including yield, throughput, deviations, and continuous improvement

cGMP Facility and Scale-Up

• Lead manufacturing readiness activities for the new facility including operational readiness, staffing, training, and go-live execution
• Work hands-on with Engineering, Facilities, Quality, and 3rd parties to support equipment qualification and manufacturing area readiness
• Develop manufacturing strategies to support early and late-stage clinical as well as commercial manufacturing for future production and capacity expansion

MSAT & Process Ownership

• Oversee MSAT responsibilities including process characterization, tech transfer, and process validation
• Hold the MSAT team to a high bar for scientific and engineering excellence, ensuring process decisions are grounded in robust data and mechanistic understanding
• Drive data-driven process improvements under manufacturing and analytical data to improve robustness and consistency

People, Strategy, and Organizational Development

• Build, mentor, and develop a high-performing Manufacturing and MSAT team capable of operating in a fast-moving startup environment
• Establish and implement lightweight manufacturing organizational structures, workflows, and standard practices appropriate for a growing GMP operation
• Provide clear technical and operational input to leadership on manufacturing risks, timelines, and scale-up strategy

Education

• Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Chemistry, or a closely related technical discipline required
• Advanced degree (M.S. or Ph.D.) in a related field preferred

Experience

• 8 years+ of experience in GMP manufacturing, MSAT, process engineering, or technical operations within biotech, biopharma, or related regulated manufacturing environments
• Demonstrated experience leading or directly supporting GMP manufacturing operations including hands-on involvement
• Prior experience supporting or leading startup activities in new facilities or new manufacturing suites
• Experience managing and developing small, highly technical teams, preferably in a startup environment
• Experience in early-stage or clinical manufacturing environments (pre-IND through Phase II) strongly preferred

Skills & Competencies

• Strong engineering or related technical foundation, with the ability to reason from first principles about process behavior, risk, and variability
• Hands-on GMP manufacturing expertise, including deviation investigation, root-cause analysis, and process troubleshooting on the production floor
• Data driven decision making, using experimental design and trend analysis of manufacturing data to improve robustness and consistency
• Ability to translate experimental processes into manufacturable GMP operations, balancing rigor, speed, and fit-for-stage execution
• Clear technical and organizational communicator and cross functional collaborator. Able to align operations, engineers, scientists, and leadership around sound technical decisions

Please apply at – in subject line: Head of Manufacturing

This is a full-time, on-site position located in Thousand Oaks, California, and requires working on-site Monday through Friday.All applicants must be authorized to work in the United States. We are not sponsoring employment visas.

Compensation: The salary range for this position is $130,000.00. to $180,000.00 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.

20BLOC is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status, or other applicable legally protected characteristics.

We offer competitive compensation and benefits including health, dental, vision and life insurance, 401(k) and paid time off.

We are seeking a Senior Materials Engineer to join a rapidly growing advanced manufacturing company in the sustainable technology sector. This role will support the scale-up of high-performance, powder-based manufacturing processes and play a key role in the company’s next phase of technical growth.

What you’ll do

• Lead hands-on experimental development across powder processing, consolidation, forming, and thermal processing
• Design and execute experiments that translate into scalable manufacturing improvements
• Apply materials characterization techniques (SEM, XRD, particle size analysis, etc.) to drive process optimization
• Partner with production and R&D teams to scale processes from pilot to manufacturing
• Mentor technicians and engineers; develop SOPs and technical documentation

What we’re looking for

• M.S. or Ph.D. in Materials Science, Metallurgy, Mechanical Engineering, or related field
• 5+ years of experience in manufacturing or process development
• Strong background in powder-based materials processing
• Hands-on experience with pressing, sintering, or related thermal processes
• Ability to manage multiple projects in a fast-paced environment

This is a high-impact opportunity offering competitive compensation, strong benefits, and long-term growth while working on advanced manufacturing technologies of strategic importance.

*This is not a job with ForceBrands*

Our client is a family-run, rapidly expanding juice and beverage facility launching a brand new state-of-the-art production lab and processing operation. Our work includes juice production, blending, co-packing, and new product development (R&D). We value people who are hands-on, responsible, and excited to grow with a dynamic team.

Position Overview

We’re seeking aManagerto oversee daily quality testing, ensure product integrity, and support R&D and production teams. Winery knowledge is not required, but general beverage or food lab experience is helpful.

Key Responsibilities

• Perform routine lab analysis (Brix, pH, acidity, micro checks, visual checks, etc.)
• Monitor QC checkpoints during receiving, blending, and packaging.
• Assist with R&D trials, new beverage formulations, and pilot batches
• Maintain lab cleanliness, calibration, safety standards, and documentation
• Communicate data clearly to production team and ownership
• Support compliance with food safety programs (HACCP, FSMA, etc.)
• Work closely with leadership in a fast-moving production environment

Qualifications

Required:

• Experience in beverage, juice or related laboratory testing
• Work as an important team player with all related disciplines: blending, storing, processing, bottling
• Understanding of basic lab instrumentation and QC record-keeping
• Strong attention to detail and problem-solving skills
• Ability to work well within a team and take initiative

Preferred (but not required):

• Experience in beverage manufacturing, blending, juicing, co-packing, or similar roles
• Lab work with wine and alcohol a plus
• R&D or new product development experience
• Food safety certifications (HACCP, PCQI, etc.)

Why Join Us?

• Be part of a new, cutting-edge juice and beverage facility
• Work directly with ownership in a family-run environment
• Growth opportunities as we expand production and R&D
• Competitive salary, benefits, and performance incentives.
• Long-term leadership potential.

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person

Title

Electrical Controls Engineer/Industrial Electrician

Report to

Facility/Engineering Director.

Job Summary

Individual must be able to perform design,engineering, and field start up responsibilities for System Integration in the Electrical Controls Industry. In addition, proven trouble

shooting skills are necessary.

Job Duties / Responsibilities

• Design, fabricate, and install PLC based process control panels.
• Troubleshoot and upgrade existing control panels.
• Maintain inventory of all PLC/HMIrack systems and programs.
• Work to install110V, 220V, and 480V 3 phase wiring.
• Real electrical schematics and wiring diagrams.
• Be able to troubleshoot 480V electrical control systems.
• Specify wiring and motor controls for 480V systems.
• Install power distribution and protection systems.
• HMI Interfaces
• Temperature Controllers and Transmitters
• Pressure Transmitters
• 4-20ma Loop Controllers
• Burner Controllers and Actuators
• Industrial pH Meters
• Level Transmitters
• Flow Meters
• Variable Frequency Drives

Work Conditions

• Physically available to lift up to 50lb.
• Exposure to hazardous conditions associated with the Company
• 24/7 availability may be required.
• Manual dexterity and the ability to remain standing, crouching, and bending for long periods of time
• Overtime as needed.

Job Requirements

• AS, BSEE, BSEET, or technical degree.
• 3-5 years of industry experience.
• Review projects including quotes, job specifications, and resolve any quote to job specifications differences.
• System Architecture including non-standard material and control pane lpower requirements/distribution.
• Review specifications and standard practices – inclusive of the internal hardwired and logic standards, general specifications and scope of work.
• Design requirements which include establishing non-standard designs, generating system map layouts, generating a sequence of operations, reviewing cycle time

studies and dimension switch layouts, generation of design packages, design logic, enter logic, and the design of Smart Displays.

• Material responsibility includes advance material order, specifying Mod Box material, specifying Panel material, writing Mod Box EBMs and writing panel material EBMs.
• Assisting with installation • Debugging with no additional support • Launchand Standby
• As Builts

Technology Requirements

• RSLogix 5, 5000
• RS Networx for DeviceNet, ControlNet, EtherNet IP
• DriveExecutive, DriveExplorer

• PanelBuilder PDS, 1400e, 32
• RSView Studio
• Trouble Shooting PID Loops
• Calibrating Process Control Equipment
• Microsoft Office Suite

Benefits

• Competitive Compensation

- 401(k)

• 401(k) Matching
• Medical, Dental,and Vision Benefits
• Paid Time Off and Paid Holiday’s

Classification

Full Time Position

Job Location:

Sacramento, CA 95834.

About the Job:

Title of the Position: Automation Technician

The Automation Technician ensures reliable operation of sterile pharmaceutical manufacturing systems by installing, maintaining, calibrating, and troubleshooting automation components, process instrumentation, drives, motors, control devices, clean utility systems, and aseptic production equipment. The role supports continuous and compliant operations under cGMP, FDA 21 CFR Part 11, and cleanroom standards.

Responsibilities:

• Install, maintain, calibrate, and troubleshoot sensors and transmitters for pressure, temperature, flow, level, pH, conductivity, and environmental monitoring.
• Support in performing GMP‑compliant calibrations with complete traceability and accurate documentation.
• Install, maintain, and troubleshoot motors, pumps, fans, drives, control devices, and sterile manufacturing equipment.
• Perform conduit bending, cable routing, wire pulling, cable termination, tray installation, and equipment connections in accordance with plant procedures.
• Install and modify control panels, junction boxes, and instrumentation assemblies.
• Diagnose issues in circuits, protection components, sensors, actuators, drives, and automated machines.
• Use diagnostic tools such as multimeters, clamp meters, insulation testers, and calibration instruments.
• Support PLC, HMI, SCADA, BMS, and EMS platforms, including troubleshooting and system checks.
• Conduct loop checks, functional tests, FAT/SAT, commissioning, and support validation activities (IQ/OQ/PQ).
• Maintain and troubleshoot systems for PW, WFI, Clean Steam, CIP/SIP, HVAC/HEPA controls, and aseptic filling/packaging operations.
• Read and interpret P&IDs, wiring diagrams, schematics, ladder logic, and loop drawings.
• Maintain cleanroom support systems, including differential pressure controls, HEPA filtration, and environmental monitoring.
• Ensure compliance with cGMP, cleanroom classification requirements, FDA 21 CFR Part 11, and data integrity principles.
• Perform preventive, corrective, and predictive maintenance.
• Conduct root‑cause analysis and implement CAPA actions.
• Maintain accurate CMMS entries, calibration logs, and audit‑ready documentation.

Working Condition:

• Ability to work rotating, weekend, or extended shifts.
• Exposure to high‑noise areas (PPE provided).
• Frequent work on mezzanine floors, elevated platforms, ladders, and step‑ups.
• Work inside aseptic cleanrooms and controlled environments (ISO 5/7/8) wearing full gowning.
• Exposure to hot, cold, humid, or pressurized utility systems such as PW, WFI, Clean Steam, and HVAC units.
• Occasional work in tight spaces, behind panels, or equipment enclosures.
• Regular use of PPE, including sterile gowning, gloves, and eye protection.
• Ability to lift to 50 lbs and perform hands-on tasks for extended periods.

Qualifications:

Education:

• BE – Mechanical/Chemical from a reputed University

Experience: Minimum 5 to 10 years of professional experience in the field of pharmaceutical or manufacturing industry.

Knowledge, Skills, and Abilities: Functional:

• Strong troubleshooting skills across sensors, transmitters, motors, drives, actuators, control components, automated machinery, and process systems.
• Experience with conduit bending, tray installation, cable pulling, wire routing, cable dressing, and termination.
• Proficiency in installing and modifying panels, junction boxes, and equipment assemblies.
• Skilled in using multimeters, clamp meters, insulation testers, and calibration devices.
• Ability to install, connect, and terminate control wiring and instrument cabling for field devices.
• Understanding of circuits, drives, starters, protection components, actuators, and control system diagnostics.
• Ability to read and interpret P&IDs, schematics, wiring diagrams, ladder logic, and loop documentation.
• Knowledge of GMP requirements, sterile manufacturing, cleanroom practices, aseptic operations, and validation processes.
• Strong documentation discipline, attention to detail, and audit readiness.
• Ability to work efficiently and safely in regulated manufacturing environments.

Behavioral:

• Result oriented
• Innovative thinking
• Time Management, Professional Work Conduct at all times
• Problem-solving ability & High level of self-motivation
• Strong interpersonal relationship skills
• Strong written & verbal communication skills

Requirements:

• Valid driver's license and acceptable driving record
• Legally authorized to be employed in the United States
• Must live or be willing to move to the Sacramento Metropolitan Region (Approx 40 miles' radius)

Benefits:

• Competitive Salary: $80,000 - $90,000
• Yearly bonus eligibility
• Benefits: offers a wide variety of benefits and programs to support health and well-being, including medical, dental, and vision coverage
• Paid time off plan
• 401k savings plan

Immediate need for a talented Specialist 4 - Medical Writing/Medical Writer, Medical Information, Payer and Health Systems. This is a 06 Months Contract opportunity with long-term potential and is located in Titusville, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-06073

Pay Range: $50 - $69/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Payer Scientific Content and Materials – 70%
• Supports the development and timely dissemination of tailored, evidence-based scientific materials for assigned therapeutic area products.
• Member of the multi-disciplinary team tasked with reviewing and approving of Payer regulated content prior to it being used
• Supports the development of AMCP standard and pre-approval dossiers, Medicaid formulary requests, and custom requests working collaboratively with Medical Affairs and Real-World Value & Evidence (RW V&E) therapeutic area leads.
• Engages in shaping and development of the Payer Digital Assets in collaboration with Med Info CSI/
• Digital partners.
• Works closely with RW V&E Field, Medical Affairs Therapeutic Area team(s) and Medical Information Scientific Engagement Contact Center to guide creation and delivery of responses to unsolicited Medical Information Requests from Payers and Health Systems
• Supports the development and dissemination of scientific information in support of assigned products to Clinical Decision Resource Organizations (CDRO) in partnership with Medical Information Affairs, RW V&E, SCG, Therapeutic Teams
• Support interactions with drug compendia and collaborates with AD, Med Info PHS and business partners to evaluate strategies for compendia interactions.
• Ensures optimized delivery of high-quality and efficient Payer scientific content and materials by vendors, provides real-time feedback and first line scientific review of materials as needed. Voice of Customer and Metrics – 20%
• Leverage voice of customer and other sources of customer information and identify actionable items to enhance the development of Payer and Health Systems materials.
• Projects and Research – 10%
• Participates in ad-hoc projects and activities as assigned by management.
• Conducts benchmark and research on the landscape of Payer, Healthcare Intermediaries, and health systems

Key Requirements and Technology Experience:

• Key skills: Payer Scientific Content and Materials
• Voice of Customer and Metrics
• Works closely with RW V&E Field, Medical Affairs Therapeutic Area team(s) and Medical Information Scientific Engagement Contact Center
• Excellence in leadership skills, collaboration in a matrix environment, influencing, ability to work both individually and as a team contributor
• Excellence in communication (both written and presentation), pharmaceutical industry experience
• Expertise in the healthcare industry, clinical knowledge, or practice across multiple therapeutic areas

Our client is a leading Pharmaceutical industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

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