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 Overview:
The Commercial Data Enablement team within IT is seeking a consultant to support the management, documentation, data lineage tracking and delivery of data-driven initiatives supporting Commercial Effectiveness, Market Access and Marketing teams. The consultant will report to the Associate Director, Commercial Data Enablement, and collaborate closely with IT, business stakeholders, and the change advisory board to ensure commercial KPIs, business requirements, and project deliverables are accurately defined, documented, and implemented.

Key Responsibilities:

· Partner with Commercial Effectiveness, Market Access, and IT stakeholders to document business requirements for data and analytics initiatives.

· Facilitate requirement walkthroughs, impact assessments, and coordination across IT, business, and vendor teams.

· Leverage data expertise to depict data lineage for business rules using Snowflake and to brainstorm using data flow charts.

· Maintain and update KPI documentation, ensuring alignment across data sources, definitions, and reporting tools.

· Ensure documentation and requirements are properly stored, version-controlled, and accessible in Confluence.

· Perform quality assurance checks and execute validation of data across Snowflake, SQL Server, and BI environments.

· Perform UAT testing ensuring business requirements are met to serve stakeholder needs and to help deliver patient outcomes.

· Support project lifecycle activities, including requirements review, sign-off, and successful UAT completion.

· Drive consistent processes for change control, release validation, and stakeholder communication.

Required Skills & Experience:

· Excellent communication, stakeholder management, and cross-functional collaboration skills with ability to own and follow through on initiatives assigned.

· Demonstrated ability to coordinate business and IT teams through requirement gathering and UAT execution.

· Strong understanding of commercial data environments, including Specialty Pharmacy (SP), Claims, Specialty Distributor (SD), and HUB data.

· Hands-on experience with linking data sets using (Snowflake) and SQL.

· Familiarity with commercial data concepts (Rx claims, patient journey).

· Proficiency with JIRA and Confluence for project tracking and documentation.

Preferred Qualifications:

· Experience with BI tools (Qlik, Tableau, Power BI) for KPI visualization and Agentic AI for driving autonomous commercial workflows.

· Experience in Marketing Analytics and Salesforce Marketing Cloud (SFMC).

· Exposure to global commercial and medical affairs teams (e.g., US, Europe, Japan).

· Understanding of data cataloging, metadata management, or data quality frameworks.

Education

Bachelors degree in computer, marketing or life sciences majors. Masters preferred.

Skills and Experience

The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.
Pay Range: $80-85/hr *based on experience ]]> Mon, 13 Apr 2026 00:00:00 EDT 1

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 *depending on experience

MUST haves -

5+ years' directly relevant experience in:
• Agency recruitment - headhunting and recruiting contractors/consultants (not just direct hire positions)
• Pharma/Biotech cGMP industry experience
• 2+ years' minimum experience headhunting senior- and executive-level, technical roles.
o roles like Senior Automation Engineers, Principal Validation Engineers, Senior Project Managers (pharma industry), Capital Project Managers, Capital Project Design Engineers (greenfield sites)
• Extensive experience in LinkedIn Recruiter, hunting for qualified talent and conducting InMail outreach and follow-up]]> Wed, 08 Apr 2026 00:00:00 EDT 1 We are looking for a seasoned Enterprise Architect to join our team on a contract-to-hire basis. Your goal is to bridge the gap between complex current-state limitations and a streamlined, scalable target state that enables our business and IT partners to thrive. You’ll have a seat at the table for the most "impactful" use cases on our roadmap.

Key Responsibilities & Deliverables
Architecture Strategy & Point of View (PoV) Development
Current State Assessment: Deep dive into existing architectures to identify bottlenecks, technical debt, and scalability limitations.
Option Appraisal: Evaluate multiple architectural alternatives, providing a clear-eyed analysis of pros, cons, costs, risks & impact for each by keeping an unbiased & vendor neutral approach.
Target State Definition: Define robust target state architectures and create Architecture Point of Views (POVs) for high priority use cases in Data, AI, Cloud, Integrations and Collaboration platforms
Standardization: Develop and document architecture best practices, standards and Reference Architectures for common, repeatable use cases to ensure consistency across the enterprise.
Governance & The ARB
ARB Leadership: Present PoVs and architectural designs to the Architecture Review Board (ARB), defending technical choices while remaining open to collaborative refinement.
Process Improvement: Act as a key contributor to the evolution of our EA governance process, making it more agile, effective & non-disruptive.
Finalization: Work closely with the ARB to finalize and formalize all architectural artifacts.
Stakeholder Collaboration & Socialization
Cross-Functional Partnership: Act as the "connective tissue" between Data, Analytics, AI, and Enterprise Integration functions.
Partner Enablement: Socialize finalized standards and best practices with the application / data / solution teams & external consulting partners to ensure high-quality delivery.
Business Alignment: Translate complex technical roadmaps into business value for non-technical stakeholders.

Skills:    
Experience: 15+ years in IT, with at least 5+ years in an Enterprise Architecture role and 5+ years in a Solution / Application / Data Architecture role preferably within the Life Sciences, Med Tech or Healthcare sector

Technical Breadth: Proven experience in Cloud (GCP / AWS), Data Lake & Warehouses (Snowflake), AI/ML (Predictive AI, Generative AI, Agentic AI), Integrations (APIs, Pub-Sub, Streams, File Transfers)

Industry Domain: Prior experience in the Biopharma / Life Sciences industry is recommended or nice-to-have

Domain Knowledge: Familiarity with Life Sciences capabilities, functions (R&D, Drug Development or Clinical, Regulatory, Pharmacovigilance, Manufacturing, Medical Affairs, Commercial), and common GxP / regulated use cases

Education:    
Education: Bachelor’s or master’s degree in Enterprise Architecture, Computer Science, Information Technology, Information Management or a related discipline
Frameworks / Certifications: Certified or strong familiarity with TOGAF, Zachman Ontology Framework or similar EA framework or methodologies (but with a practical, non-dogmatic application mindset)

Minimum Degree Required:  Bachelor's Degree

Pay Range: $70-78/hr *based on experience ]]> Thu, 02 Apr 2026 00:00:00 EDT 1 Description:

Summary:
The main function of a DevOps Engineer is to build functional systems that improve software experience.
A typical DevOps engineer is responsible for deploying product updates, identifying and troubleshooting production issues as well as implementing integrations.

Job Responsibilities:

• Modify existing software to correct errors, allow it to adapt to new hardware, or to improve its performance.
• Implement integrations as requested by internal/external customers.
• Analyse user needs and software requirements to determine feasibility of design within time and cost constraints.
• Coordinate software system installation and monitor equipment functioning to ensure specifications are met.
• Design, develop and modify software systems, using scientific analysis and mathematical models to predict and measure outcome and consequences of design.
• Analyse information to determine, recommend, and plan computer specifications and layouts, and peripheral equipment modifications.
• Obtain and evaluate information on factors such as reporting formats required, costs, and security needs to determine hardware configuration.

Skills:

• Strong knowledge of DevOps practices.
• Verbal and written communication skills, problem solving skills, customer service and interpersonal skills.
• Ability to work independently and manage one’s time.
• Knowledge of computer hardware and software.
• Understanding of how various IT systems work.
• Knowledge of design techniques and principles involved in production of drawings and models.
• Experience with DevOps tools such as Puppet, Kubernetes, Jenkins or others.
• Assist in the design, implementation, and management of AWS infrastructure using EKS, ECS, API Gateway and other related technologies.
• Contribute to the automation of deployment processes using Terraform, CloudFormation, and scripting languages.
• Participate in the design, implementation, monitoring and alerting of systems and applications to ensure high availability and performance.
• Collaborate with development teams to integrate and deploy applications on AWS.
• Troubleshoot and resolve infrastructure and application deployment issues.
• Contribute to the development and maintenance of CI/CD pipelines.
• Implement best practices for security, scalability, and cost optimization in AWS.
• Document processes and configurations.
• Stay up to date with the latest AWS services and DevOps trends.

Qualifications

• Bachelor’s degree in computer science, Engineering, or a related field (or equivalent practical experience).
• Experience with the following technologies:
• Containerization technologies (e.g., Docker, EKS, Kubernetes).
• Infrastructure as code (IaC), specifically Terraform.
• Monitoring tools (e.g., CloudWatch, Prometheus, Grafana).
• Configuration management tools (e.g., Packer, Ansible).
• Relational database technology (e.g., SQL/PSQL).
• Experience with at least one scripting language (e.g., Python, Bash).
• CI/CD pipelines and related technologies.
• Linux operating systems.
• Strong problem-solving and analytical skills.
• Excellent communication and collaboration skills.
• A proactive attitude and a willingness to learn.

Pay Rate Range: $70-84/hr depending on experience  ]]> Tue, 24 Mar 2026 00:00:00 EDT 1 *Depending on experience

Responsibilities
· Provides complex medical information for the assigned therapeutic area(s). This includes developing, maintaining and using product/disease state subject matter expertise to respond to medical information inquiries escalated from affiliate and medical information call center staff, and managing the development, approval, and maintenance of global and region-specific medical/technical global content documents used for product inquiries from internal customers such as country affiliate staff, and from external customers including healthcare professionals (e.g., External Experts, physicians, pharmacists, nurses, etc.) and consumers.
· Provides timely and accurate development of GCs, summarizes literature and clinical guidelines, and assists in the development/approval of Data on File in accordance with established policies and practice standards. Ensures content conveys a clear and appropriate medical message. Provides review and approval of medical content, including complex and sensitive information. Ensures compliance with regulatory and corporate requirements.
· Able to evaluate data, and maintain an in-depth understanding of product knowledge, associated disease states, treatment guidelines, labeling, and relevant internal data for assigned therapeutic area.
· May partner with internal colleagues to ensure creation of relevant core content to meet customer needs.
· Assists in providing solutions to deliver medical information to customers in unique and innovative ways.
· Critically evaluates literature, interprets complex data, and adapts delivery of information to a variety of audiences.
· Identify global medical information insights based on Medical Information inquiries.

Essential Skills/Abilities
· Must be self-motivated, highly organized, detail-oriented and able to multitask with delivering high quality work.
· Mastery of use of computer systems, database, and software applications, including Microsoft Office, Excel, PowerPoint and knowledge of medical information’s inquiry repository, such as Veeva Vault and Salesforce preferred.
· Ability to coordinate and lead multidisciplinary and cross-functional meetings. Must possess excellent interpersonal, communication, and leadership skills.
· Understanding of the legal and regulatory environment of pharmaceutical industry desired.
· Possesses strong teamwork attributes and cultural sensitivity.
· Must possess excellent oral and written English communication skills. Medical writing skills highly desired.
· Maintains expert understanding of product knowledge, labeling, and relevant data. Able to apply knowledge across multiple therapeutic areas.
· Solid clinical understanding of disease states and the implications of treatment. Strong knowledge of clinical trial methodology, statistical concepts, and independent evaluation and interpretation of complex literature.

Qualifications (education and experience)
· Bachelor’s degree and graduation from an accredited Nursing, PA, Pharmacy, PhD in Health Sciences, or MD/DO program.
· Advanced degree preferred.]]> Mon, 16 Mar 2026 00:00:00 EDT 1  

Associate Director, Global Submission Management

The Associate Director of Global Submission Management (GSM) is responsible for leading, managing, strategizing, and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. This role involves providing hands-on operational support for submission activities while ensuring strategic alignment and process optimization across different regions. It also includes resource planning, budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads of Submissions Management for the EU and Japan as needed and utilize “Follow-the-sun” processes to ensure submission timelines are met regardless of the region.

The Associate Director, Global Submission Management (GSM, is responsible for the effective operation of Global Submission projects, ensuring the consistent application of global procedures and standards, and proactively assessing process performance for necessary optimizations.  The Associate Director serves as the primary liaison between R&D functions, acting as the submission lead for designated global applications (e.g., INDs, NDAs, MAAs, supplements, amendments, and variations), to facilitate cross-functional logistics and communication that support submission planning. This role provides submission leadership by managing the operational aspects of global regulatory submissions to produce high-quality, time-sensitive deliverables in accordance with agreed-upon submission timelines.  Additionally, the AD oversees the process for creating and updating the Global Regulatory Operations Submission Content Plan (GSCP) for major regulatory submission final deliverables, ensuring compliance with applicable regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, HC, PMDA, Emerging Markets, ICH, CDISC) within defined timelines.

 

Essential Functions:

 

Leadership and Strategy

• Provides leadership for the Global Submissions Team ensuring projects are appropriately resourced, partnering with other regional Submission Heads for additional support for resources when needed. 
• Provides the Regulatory Submission Management for a lead compound or submission project that has been identified as critical to business success.
• Provides management oversight for the Global Submission Management department, supporting the generation, and when necessary, the re-engineering of “Best Practices” related to global submission management and dossier development in pursuit of optimal processing performance while maintaining full compliance with Health Authority requirements and guideline.

 

Global Collaboration

• Collaborates with the EU and Japan Heads of Submission Management to optimize resource allocation and implement “follow-the-sun” workflows for timely submissions across all regions.
• Foster strong cross-regional communication and collaboration to support global objectives.
• Promotes a culture of performance and teamwork, with a focus on staff development in technical skills, interpersonal skills, education, and training, enhancing competency and professionalism.
• Maintains visibility within the organization by regularly presenting on various GSM-related topics. This includes showcasing the achievements, ongoing projects, and developments of the GSM organization, as well as emerging trends in eCTD regulatory submissions. Additionally, cultivate positive and constructive relationships with other members of the Global Regulatory Operations (GRO) team and regulatory colleagues.
• Actively participates in agency/industry events regularly, staying abreast of current developments, trends, and technologies, fostering constructive business relations with other industry peers, Health Authority representatives, and critical business partners/vendors.
• Analyzes trends and evaluates the impact of changes in Health Authority requirements for e-submissions, communicating these changes to the relevant areas within and driving the necessary changes to processes and procedures.
• Ensure the timely completion of all administrative tasks for this position, including but not limited to monthly reports, performance objective setting, performance reviews, and training, for self and staff.

 

Hands-On Submission Support

• Actively participates in submission planning and execution, including document compilation, publishing, and quality checks.
• Provide technical oversight and troubleshooting for eCTD submissions and related systems.

 

Operational Excellence

• Ensure consistent application of GSM global procedures and standards.
• Proactively monitors and assess process performance, identifying opportunities for continuous improvement.

 

 

Requirements

• Bachelor’s degree in scientific or information technology field; advanced degree preferred
• 8+ years of pharmaceutical industry regulatory experience
• 5+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions required
• Proficient with U.S. and EU submission requirements including but not limited to Emerging Markets
• Advance experience with the drug development process and eCTD regulatory submission standards
• Expert understanding of Project Management concepts and techniques
• Ability to apply SOPs regulations pertaining to electronic submissions
• Ability to lead cross-functional team, establish effective relationships with team members and work well in a cross functional team environment
• Advance experience creating timelines for the development and submission of drug filings to regulatory health authorities
• Excellent organizational skills to support multi-task and manage submission timelines in a fast-paced environment with changing priorities
• Well-organized with the ability to multi-task and work with minimal supervision
• Ability to manage change to support organization’s effectiveness by implementing change
• Effectively communicates written and verbal communication skills
• Demonstrates strong analytical, problem solving and critical thinking skills with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution.
• Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)

 

Technical Skills Required

• Advance working knowledge of global regulatory submission standards, publishing software, software validation concepts, and regulatory publishing best practices
• Proficiency in eCTD publishing tools (e.g., Lorenz docuBridge, Extedo eCTDmanager, or equivalent).
•  Strong understanding of ICH guidelines, regional regulatory requirements, and data standards (e.g., CDISC).
• Extensive experience with Regulatory Information Management (RIM) systems and Document Management Systems (e.g., Veeva Vault, SharePoint, Documentum)
• PowerPoint, SharePoint, XML, Adobe Acrobat, ISI Toolbox and eData transfer systems
• Ability to troubleshoot technical issues related to electronic submissions and publishing.

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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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