https://CAREERS.PLANET-PHARMA.COM/ en-us 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
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 Drug Safety Associate

Responsibilities

• Ensure timely and accurate processing of adverse event reports in accordance with company policies and regulatory requirements
• Conduct thorough investigations and evaluations of adverse events, including reviewing medical records and collaborating with cross-functional teams
• Maintain a thorough understanding of product safety profiles and provide timely updates to internal stakeholders
• Monitor and analyze safety data to identify potential safety issues or trends and recommend appropriate actions
• Develop and maintain strong relationships with external partners, such as regulatory agencies and contract research organizations
• Assist with the development and implementation of pharmacovigilance processes and procedures
• Ensure compliance with all applicable regulations and guidelines related to pharmacovigilance
• Participate in cross-functional meetings and contribute to the development of risk management plans for products
• Support the preparation and submission of regulatory reports and responses to safety-related inquiries
• Collaborate with other departments, such as Clinical Development and Medical Affairs, to ensure the safety of products throughout their lifecycle
• Maintain accurate and up-to-date documentation of all pharmacovigilance activities
• Handling administrative tasks related to safety reporting, including filing, preparing cover letters, managing translations for required local languages, and completing submission forms as
• Working with minimal supervision, will oversee all aspects of pharmacovigilance (PV) safety reporting from project start-up through close-out, according to the agreed scope of work
• Participates in project teams, and where required provides training and support to team members in respect of safety reporting

 

Qualifications

• Education – bachelor’s degree or equivalent professional experience
• Previous experience of 2+ years of Pharmacovigilance / Drug Safety in a CRO or Pharma, Biotech environment.
• Preferably, experience of safety report distribution and submission, as well as healthcare administrative
• Training – Strong understanding of Good Clinical Practices (GCPs) and familiarity with global safety reporting regulations, including those from EMA, FDA, MHRA, other regions, and ICH guidelines
• Exceptional attention to detail with a focus on accuracy and meticulous
• Ability to multi-task, prioritize, and manage time effectively to handle multiple project assignments
• In-depth understanding of global and local pharmacovigilance (PV) regulations
• Understanding of medical terminology and familiarity with coding dictionaries g
• Experience with ArisG or a similar Safety Database a plus.
• Strong project management, interpersonal, verbal and written communication

]]> Wed, 08 Apr 2026 00:00:00 EDT 0

Join the Immunology & Respiratory Department’s Discovery Sciences Team to identify and develop transformational drugs for immune-mediated diseases.

As in vitro scientist, you will work closely with the project leader and in vitro lead to develop, validate, and execute assays to modulate lymphocytes.

Work closely in a matrix global team to meet project achievements, with the goal to deliver therapies that transform the lives of patients.

 As in vitro scientist on projects, you will design and execute in vitro assays for target validation, compound profiling and hit validations.

 Work closely with project lead and in vitro lead to deliver high quality assays.

Interact with other scientists in the group to share assay protocols and seek feedback on assay design and troubleshooting.

Maintain accurate and reliable records including electronic notebooks and all other pertinent documentation.

Present data at project team meetings and group meetings Skills:    

• Prior experience working in pharma or equivalent industry is not required but will be considered a plus.
• Prior experience with establishing and validating in vitro assays for lymphocyte functions and modulations (B and T cells) is desired.
• Experience in gene knockdown, CRISPR, validation is desired but not necessary
• Experience in immune phenotyping and functional assays, including multicolor flow cytometry (10+ colors), ICS, ELISpot, proliferation assays, and cytokine ELISA/MSD.
• Analyzing data using biological and statistical software such as Prism, FlowJo, OMIQ, Excel, etc.

Education:    

• Master’s degree from an accredited institution with one-plus (4+) years of experience in a related scientific discipline (Biology, Immunology, Cell biology) OR Bachelor’s degree from an accredited institution with seven-plus (7+) years of experience in a STEM discipline.

Pay Rate Range: $40-51/hr depending on experience ]]> Fri, 03 Apr 2026 00:00:00 EDT 1 Key Responsibilities:

• Execute tissue processing to prepare high-quality samples for analysis, ensuring consistency and adherence to established protocols.
• Conduct tissue embedding using paraffin and frozen section techniques to enable accurate sectioning and downstream applications.
• Perform tissue staining, including immunohistochemistry (IHC), immunofluorescence (IF), and histological staining, to support imaging and research goals.
• Troubleshoot and optimize protocols to ensure reproducible, high-quality results.
• Collaborate with researchers to design experiments, analyze data, and interpret findings.
• Maintain detailed records of procedures, results, and inventory in compliance with laboratory standards.

Skills:    
Required Qualifications and Skills:

• Experience: 3-5 years of hands-on experience in tissue processing, tissue staining, and tissue embedding in a research or clinical laboratory setting.
• Technical Skills:
• Proficiency in histological techniques, including paraffin and cryosectioning.
• Expertise in IHC, IF, and other histological staining methods.
• Ability to troubleshoot and optimize tissue preparation protocols.
• Analytical Skills: Strong attention to detail and ability to analyze and interpret experimental data.
• Organizational Skills: Excellent time-management and multitasking abilities to handle multiple projects efficiently.
• Communication Skills: Clear written and verbal communication for collaborating with researchers and documenting procedures.
• Teamwork: Ability to work both independently and collaboratively in a team-oriented research environment.
• Compliance: Familiarity with laboratory safety protocols and quality control standards.

Education:

• Master’s degree in biology, biomedical sciences, or a related field (bachelor’s degree with significant relevant experience may be considered).

Pay Rate Range: $30-41/hr ]]> Fri, 03 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

Provides administrative support for specific tasks within a specified department or departments.

 Support may include: data entry, coordination of conference rooms and meetings, travel arrangements, records retention and file management, inputting and tracking purchase orders, and invoices through the internal system, ordering and managing departmental supplies, expense report reconciliation, training class support, and general staff support.

Performs all Company business in accordance with all regulations and Company policy and procedures. Demonstrates high ethical and professional standards with all business contacts and BIPI employees in order to maintain the Company's excellent reputation within the medical and pharmaceutical community.
Skills:    

• Proficient in MS Word, Excel, powerpoint, and Outlook. Excellent written and verbal communication skills. Strong attention to detail and organizational skills. High degree of initiative, accountability, accuracy, problem solving ability and follow-up skills. Strong customer service skills and the ability to maintain confidentiality.
• Expereince with the following software:
  • SAP (In particular for PO creation)
  • Concur 
  • Docusign 

Education:    

• Bachelors Degree and 2-5 years of experience    

Pay Rate Range: $20-27/hr depending on experience ]]> Fri, 13 Mar 2026 00:00:00 EDT 1

Design, develop, and execute functional genomics assays, including CRISPR-based editing (e.g., RNP delivery, Perturb-seq), single-cell sequencing, spatial transcriptomics, and CITE-seq.

Provide technical guidance and training to research scientists on FGSL technologies and techniques, including assay execution, troubleshooting, and resolution of technical issues;

Documents and maintains detailed laboratory records in accordance with policies;

Operates and maintains lab equipment in collaboration with other lab members;

Assists acquisition of necessary supplies and equipment;

Defines and performs appropriate QC measures; 

Follows relevant scientific literature to ensure use of optimal methods and understand emerging practices across the field;

Demonstrates the ability to interpret the outcome of experiments, propose appropriate follow-up, and may propose new avenues of investigation;

Communicates own work effectively orally and in writing; contributes to writing protocols, procedures, and technical reports

Automate processing and results reporting and delivery;

Reports and treats data with a high level of integrity and ethics.  Skills:    

• CRISPR assays - Must have personally designed guides, performed transfections/infections, selected edited cells, and validated knockouts/knockins
• Next-generation sequencing (NGS) - Hands-on library preparation experience (not just data analysis)
• Single cell technologies - Personal experience with sample prep, library generation, and quality control
• Standard molecular biology techniques - qPCR, Western blot, cloning, gel electrophoresis
• Cell culture - Proficient in maintaining multiple cell lines, transfections, and sterile technique
• Experience in automation is a plus;
• Able to perform variety of FGS experimental techniques at the same time;
• Demonstrated experience working in a multi-disciplinary and collaborative environment;
• Ability to troubleshoot FGS experiments both individually and as part of a team.
• Excellent oral and written skills with the ability to communicate in an open, transparent, timely and consistent manner.

Education:    

• Master’s degree from an accredited institution with 4+ years of experience in molecular, cell biology, or related scientific discipline.

Pay Rate Range: $35-49/hr depending on experience ]]> Thu, 05 Mar 2026 00:00:00 EST 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.

]]> Tue, 20 Jan 2026 00:00:00 EST 0