https://CAREERS.PLANET-PHARMA.COM/ en-us CMC Technical Writer – MSAT (Contract)
? US Remote or Hybrid
? 3–6 Month Contract
 
About the Role
We are seeking a highly experienced CMC Technical Writer to serve as the primary author for global regulatory submissions supporting commercial pharmaceutical products. This is a high?impact, senior individual contributor role with full ownership of complex CMC content across global markets.

The ideal candidate brings deep expertise in CMC documentation, strong scientific and manufacturing understanding, and proven success writing for FDA, EMA, and other major health authorities. This role offers full autonomy, cross?functional visibility, and the opportunity to influence regulatory success across a global supply network.

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Why This Role Is a Great Opportunity

• Act as the primary CMC author for global submissions on commercial and late?stage assets
• Highly autonomous role with no people?management responsibilities
• Significant impact on regulatory strategy, submission quality, and inspection readiness
• Broad cross?functional exposure (MSAT, Regulatory, Quality, CMOs)
• Remote?friendly position supporting global product lifecycle activities

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Key Responsibilities CMC Technical Writing & Documentation

• Independently author and revise complex CMC sections for global regulatory submissions, including original applications, supplements, variations, and technical responses.
• Translate MSAT, manufacturing, and CMO data into clear, accurate, regulator?ready content.
• Ensure documentation accurately reflects process understanding, control strategies, and commercial manufacturing activities.

MSAT Collaboration & Technical Alignment

• Partner with MSAT SMEs to capture, structure, and articulate detailed product and process knowledge.
• Maintain consistency across internal technical documentation and global regulatory filings.
• Serve as a documentation authority, advising on structure, detail, and clarity.

Global Regulatory CMC Support

• Provide hands?on authorship for global submissions (FDA, EMA, international agencies).
• Prepare and refine technically complex responses to health authority questions.
• Support inspection preparation through high?quality, inspection?facing documents.

Lifecycle & Change Management Support

• Manage CMC documentation updates to support post?approval changes.
• Ensure global consistency across historical and current filings.
• Support documentation for change controls, deviations, investigations, and process changes.

External Partner / CMO Collaboration

• Work directly with CMOs to obtain and integrate technical information.
• Support onboarding of new manufacturing partners with accurate documentation capture.

Quality, Compliance & Independence

• Deliver inspection?ready, compliant submissions aligned with ICH, GMP, and global CMC guidelines.
• Apply and refine templates, style guides, and documentation standards.
• Operate independently, managing timelines and priorities with minimal oversight.

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Top Required Skills

• 15–20 years of experience in CMC documentation, regulatory writing, MSAT, or technical operations
• Extensive authorship of CMC sections for FDA, EMA, and global submissions
• Advanced degree (MS/PhD) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline
• Deep understanding of drug substance/drug product manufacturing, control strategies, and lifecycle management
• Expert knowledge of ICH guidelines, GMP expectations, and global CMC requirements

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Preferred Qualifications

• Experience supporting multi?regional submissions and post?approval changes
• Background in process chemistry or pharmaceutical development
• Proven success preparing documentation used during regulatory inspections
• Experience as a documentation authority within MSAT or Technical Operations

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Key Competencies

• Expert?level technical writing and editing
• Ability to independently synthesize complex scientific information
• Strong judgment and attention to detail in a regulated environment
• Effective communication across technical and non?technical teams
• Ability to manage multiple complex documents and timelines autonomously

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Location & Travel

• US Remote, or Hybrid (PA)
• Up to 5–10% travel to domestic or international manufacturing sites

]]> Mon, 13 Apr 2026 00:00:00 EDT 0

Lead end-to-end implementation, configuration, and integration of Thermo Fisher SampleManager LIMS

Gather existing laboratory and shop-floor workflows; translate them into digital processes

Coordinate interfaces between LIMS and laboratory systems.

Drive CSV activities: author URS, execute IQ/OQ/PQ protocols, and other deliverables.

Provide on-site deployment and hypercare support for go-live

Collaborate with cross-functional stakeholders to ensure user adoption Requirements:

• Minimum of Bachelors Degree in STEM field.
• Experience working with Thermo SampleManager LIMS and GMP environments.
• Proven track record implementing and validating enterprise applications.
• Solid experience integrating LIMS with slaboratory systems.
• Hands-on expertise in CSV (Computer System Validation) and GMP compliance.
• Strong stakeholder management skills.

 ]]> Mon, 13 Apr 2026 00:00:00 EDT 1 *depending on experience

Brief Description:

The R&D Project Planner role works closely with and under the direction of Project Management Leads (PMLs) or R&D PMs, providing day to day project planning to support the timely execution of specific project goals and objectives and to maintain accurate reporting information. 

Essential Functions
•    The Project Planner supports the PML or R&D PM:
o    Generating and updating accurate day to day project plans under the direction of the PML, requiring interaction with Functional Matrix Teams (FMTs) to understand their activities, their interdependencies across the project.
o    Gathering updates from FMTs to monitor and reporting progress to the agreed plan, with particular awareness and focus on critical path activities, alerting the PML and R&D PM promptly to facilitate resolution.
o    Creating and maintaining standard Gantt views for team review, following the R&D PM conventions.
o    Generating scenario options ahead of project team meetings, sometimes at short notice and on occasion live in group settings.
o    Presenting and providing detailed planning project knowledge in working meetings, advising teams of interdependencies and in particular impact on the critical path to key milestones
o    Ensuring with the PML, that Planisware (the official corporate planning system) is maintained accurately to support downstream Portfolio Reporting and Divisional resource forecasting
•    Serves as the Planisware scheduling ‘super user’ for the R&D Project Management Team
o    Provides professional planning direct input and support for multiple Project Teams
o    Interacts with the Business Support Organisation (BSO) to maintain Planisware compliance and to facilitate system updates, improvements and user training.

Required Knowledge, Skills, and Abilities
•    Team player
•    Experience using Planisware for project planning purposes
•    Ability to collaborate cross-functionally, leveraging appropriate company tools
•    Curious and inquisitive mind with confidence to ask questions and seek clarifications
•    Excellent technical aptitude and computer software skills
•    Aptitude for working with computer systems
•    Previous experience or Interest in the drug development process and Project Management
•    Working knowledge and ideally a track record of using planning applications e.g. Microsoft Project, Planisware, etc.
•    Attention to detail
•    Problem solver
•    Excellent written and verbal communications skills

Required/Preferred Education and Licenses
•    Bachelor in science degree or equivalent ideally in a life sciences, mathematics, or engineering discipline
•    Project Management Professional Qualification (e.g. PMP, PRINCE2, etc) a plus

 ]]> Mon, 13 Apr 2026 00:00:00 EDT 1 ?Essential Functions/Responsibilities
??Collaborate with BPOs, SMEs and relevant stakeholders to create or revise
process?documents
? Promote continuous process improvement across R&D, in alignment with best
practices and?regulations
??Provide process expertise and document guidance to R&D BPOs across multiple
functional?areas
??Support the integration of process documents
??Support BPOs with timely completion of process document periodic reviews
??Create process maps using Microsoft Visio, as applicable
? Support the development of training materials and quizzes as required
??Promote the use of R&D BPO networks to ensure a consistent approach to
process?development
? Support ongoing inspection or audit readiness activities
? Perform the role of training coordinator if necessary for applicable process
documents.
? Lead or contribute to authoring and implementation of change controls in EDMS
related to procedural documentation, as applicable
?

?Required Knowledge, Skills, and Abilities

??Self-motivated and achievement-oriented, with the ability to operate in a
changing?environment
??Excellent understanding of processes within Biopharmaceutical
R&Dorganization
??Demonstrated success in authoring process documents or functioning as a
business process?owner (preferred)
??Strong negotiation skills, routinely demonstrated in a cross-functional setting
??Strong networking skills, with the ability to facilitate, collaborate with cross-
functional teams such as?Pharmacovigilance, Global Regulatory Affairs, and
Clinical Operations
??Demonstrated track record of driving process improvement activities
??GxP knowledge
??Strong attention to detail, along with excellent written and verbal communication
skills
??Strong ability to implement a systematic approach to problem solving and
prioritize tasks to?meet deadlines
??Maintain a continuous process improvement mindset
??Strong EDMS experience
??Proficient in Microsoft Office, including Visio
?Required/Preferred Education and Licenses
??Bachelor’s degree with 5 years of experience in a scientific, clinical, process
improvement, or?similar role (required)
]]> Mon, 13 Apr 2026 00:00:00 EDT 1
Scientist, III – Biocompatibility, Tissue Material Sciences (Contractor)

JOB SUMMARY:
The Senior Scientist I - Biocompatibility is a SME related to the biocompatibility and nonclinical safety evaluations of medical devices, biomaterials, tissue products, and combination products as a part of R&D. This individual must possess an extensive knowledge of ISO-10993 Standards and prior experience working in biocompatibility. The position will be responsible for cross-functional and cross-site collaborations and recommendations of biocompatibility activities, including establishing requirements, planning, execution and approval of biocompatibility requirements in support of regulatory submissions, project teams, operations, with a large focus on manufacturing and change control (product support).

KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE:

• Function as Subject Matter Expert for ISO-10993 (biocompatibility) assessment management with minimal supervision. This will include the design, execution and interpretation of biocompatibility evaluation strategies and programs according to relevant regulatory requirements, including biological risk assessments, technical reports, technical memoranda and other documents for internal and external distribution, including regulatory submissions.
• Responsible for creating detailed Project Plans including scientific strategy and realistic deliverables with timelines. Actively involved in the planning, execution and management of experimental studies for the safety characterization of novel and existing products.
• May serve as a sub-team or core-team member, providing support as needed for all project Teams.
• Support for on-market products, including global change-control activities as they relate to biocompatibility. Requires interacting with Manufacturing Sites.
• Maintain knowledge of medical device regulations to assure compliance and conformance of programs for evaluation of medical device and other products. This includes performing gap analysis relevant to changes in biocompatibility standards or guidance.
• Prepare and deliver technical presentations to internal and external stakeholders with minimal supervision. Assist the team in functional training initiatives.
• Build and maintain strong connections and relationships with Contract Research Organizations, Toxicologists and Consultants for Biological Risk Assessments as needed.

Education and Experience
• Bachelor’s Degree in Life Science/Biomedical Engineering or related field with minimal 6 years of experience in a scientific role in the medical device or pharma industry or Master’s degree (with thesis) in Life Science/Biomedical Engineering or related field with at least 4 years of experience in a scientific role in the medical device or pharma industry.
• Medical device, pharmaceutical or related experience or experience in a regulated environment with a proven record of success supporting patient safety studies for R&D projects is preferred.
• Significant experience and knowledge of medical device and combination product regulations
• Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations.
• Strong technical writing and verbal communication skills.
• Experience managing outsourced contract research (GLP, non-GLP, GMP activities).
• Strong familiarity with the product development process for medical devices or biologics
• Demonstrate critical thinking and problem-solving skills, including analysis and presentation of data.
• Self-motivated and proactive; ability to execute with minimal supervision and direction. Can work independently or part of a team.
• Ability to communicate complex technical information in a clear and easy-to-understand way (both verbally and in writing).
• Author internal reports and procedures as well as collaborating on manuscripts and abstracts for external submissions.
• Knowledge of Good Documentation Practices, maintain accurate documentation & related record retention documentation.
• Knowledge of Good Laboratory Practices (21 CFR, Part 58) and ISO-10993 standards .
• Proficient in required software including Word, Excel, PowerPoint, and Outlook, and statistical software]]> Fri, 10 Apr 2026 00:00:00 EDT 1 • Lead end to end program management for CLIA based diagnostic initiatives, including IUO assay design and development, analytical verification, assay transfer, and CLIA validation.
• Drive Design Control rigor across design inputs/outputs, risk management, traceability, design reviews, and Design History File (DHF) readiness in alignment with established TM QMS.
• Partner with Pathology/IHC, Molecular Diagnostics, Device Quality, Regulatory Affairs, and Lab Compliance to ensure compliant and timely clinical enablement.
• Integrate diagnostic strategies into clinical protocols to support patient stratification and early development decision making.

Bioanalysis Program Management (GLP)
• Coordinate GLP compliant bioanalytical programs (PK/PD/ADA) supporting clinical studies, including oversight of assay timelines, critical reagents, data transfers, and CRO deliverables.
• Ensure alignment of bioanalytical execution with IND enabling and clinical milestone expectations, in partnership with Regulatory and QA.
• Proactively manage interdependencies between diagnostics and bioanalysis where programs require coordinated execution.
• Provide program management for GLP quality execution, including inspection readiness, audit/inspection coordination, and CAPA governance in partnership with QA and study teams as needed

Quality, Compliance & Data Integrity
• Operationalize QMSR/21 CFR 820, GLP, CLIA/CAP, EU IVDR, ISO 13485, and 21 CFR Part 11 requirements across laboratory operations, vendors, and data flows.
• Enforce Good Documentation Practices (GDP) and ALCOA/ALCOA+ principles across sample, method, and data lifecycles.
• Maintain inspection ready execution through disciplined documentation, validated systems (LIMS/EDMS), and audit ready records.
External Partnerships & Vendor Oversight
• Serve as the primary program interface with CROs, CLIA laboratories, IVD/CDx partners, and specialty vendors.
• Define scopes of work, timelines, and deliverables; manage risks, issues, and escalations with a patient impact lens.
• Ensure vendors meet quality, compliance, and performance expectations.
Program, Portfolio & Financial Management
• Build and manage integrated project plans, risks, and dependencies across diagnostics and bioanalysis.
• Track timelines, forecast resources, and support budget visibility for program leadership.
• Provide concise, decision focused updates to stakeholders and leadership; escalate risks early with data backed mitigation options.
Ways of Working & Culture
• Model Behaviors: Urgency & Agility, Accountability, Innovation, Integrity, and Passion for Excellence.
• Simplify interfaces, reduce operational friction, and apply data driven and AI enabled workflows where appropriate to accelerate execution.

Qualifications
Required
• Bachelor’s degree in a scientific or engineering discipline; MS preferred.
• 6+ years of experience in GxP regulated environments, spanning Precision Medicine / Diagnostics and/or Bioanalysis.
• Hands on experience with Design Control execution for IVD/CDx or IUO assays.
• Strong working knowledge of FDA QMSR (21 CFR 820), GLP, CLIA/CAP, EU IVDR, ISO 13485, and 21 CFR Part 11.
• Proven ability to lead complex, cross functional programs in matrixed organizations.  
Pay Rate Range: $55.00 - $61.00/hr/hr depending on experience ]]> Thu, 09 Apr 2026 00:00:00 EDT 1
Candidate Profile:

• 10+ years of relevant experience in an administrative or executive support role
• Experience in the biotech/pharmaceutical industry preferred
• Strong organizational and multitasking skills
• IT-savy, with the ability to work with systems like SAP

Contract Details:

• On-site presence required 2–3 days per week in Princeton, NJ
• Start date: ASAP
• Duration: 6-month contract

 

We are looking for a highly organized and proactive Management Assistant to support the Head of Global Product Quality and other executive leader in managing day-to-day activities and ensuring the efficient operation of our US activities. The ideal candidate will have exceptional administrative skills, excellent communication abilities, and the ability to thrive in a fast-paced and dynamic environment within the biotech industry.

Your mission

• Provide administrative support to the Head of Global Quality and other executive, including calendar management, scheduling meetings, and coordinating travel arrangements, and expenses management.
• Prepare and distribute presentations, and reports on behalf of management for various audiences.
• Assist in the organization and coordination of internal and external meetings and business trips.
• Act as a liaison between management and internal/external stakeholders, handling inquiries and requests in a professional and timely manner.
• Maintain accurate and up-to-date electronic and physical filing systems, ensuring accessibility and confidentiality of documents.
• Assist in the preparation and distribution of materials for board meetings, team meetings, and other strategic sessions.
• Support conducting of research and compilation of data for management to conduct decision-making and strategic initiatives
• Coordinate special projects and initiatives as assigned by management, ensuring timely completion and adherence to deadlines.
• Uphold confidentiality and discretion in handling sensitive information and communications.

Job requirements

• Bachelor's degree in Business Administration, Life Sciences, or related field preferred with 10+ years of relevant experience.
• Proven experience in an administrative or executive support role, preferably within the biotechnology or pharmaceutical industry.
• Strong proficiency with digital tools such as: Word, Excel, PowerPoint, Outlook and other relevant software applications, including business applications such as SAP, Concur and SuccessFactors
• Excellent organizational skills with the ability to prioritize tasks effectively and meet deadlines in a dynamic environment.
• Exceptional communication skills, both written and verbal, with a high level of professionalism and attention to detail.
• Ability to work independently with minimal supervision and as part of a collaborative team.
• Strong interpersonal skills with the ability to build relationships and interact effectively with individuals at all levels of the organization.

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