Responsibilities include, but not limited to:

  • This position will report to the Manager of Quality Systems
  • This position supports document processing and records management
  • Responsibilities include the organization and migration of existing company documents into a new EDMS/e-QMS
  • The position supports staff qualification documentation and generating training reports
  • Responsibilities also include support tracking periodic review of controlled documents and proposed system enhancements within the EDMS
  • Additional duties include internal customer support within the e-QMS and assistance in the preparation for regulatory agency inspections and third-party audits

Minimum Skills/Knowledge Required:

  • Bachelor’s degree or a combination of equivalent education and work experience
  • Professional with minimum 2 years of experience in a Quality Assurance or Quality Systems role pharma, biotech or healthcare environment
  • Hands-on experience managing electronic documentation software or systems
  • Must have proficient software skills in Microsoft Word, Excel, PowerPoint and Outlook as well as an aptitude for learning new software systems
  • Strong interpersonal skills and the ability to work independently as well as part of an interdisciplinary team
  • Energetic, self-motivated, organized individual accustomed to working in a virtual company environment in a deadline-focused entrepreneurial setting
  • Ability to focus on the minutia of data entry and file organization
  • Skilled in problem solving, root cause analysis, decision-making and corrective action
  • Excellent written, verbal and presentation skills

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.

EOE

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Eiger has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment.  If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.

About Eiger BioPharmaceuticals, Inc.

Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious rare diseases.  The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.  All five Eiger rare disease programs have been granted FDA Breakthrough Therapy Designation.

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Job Description

Reporting to the Senior Director, CMC Regulatory Affairs, the Associate Director/Director, CMC Regulatory Affairs is responsible for leading regulatory support for assigned programs in small molecules, biologics and peptides to ensure sound regulatory planning and tactical implementation of US and international development and marketing authorization strategies.

Responsibilities include, but not limited to:

  • Collaborates with cross-functional project teams and external business partners to develop CMC regulatory strategies and identify regulatory risks; represents the department in cross-functional project teams
  • Identifies the required documentation and any content, quality and timeline issues for global submissions and negotiates the delivery of approved technical documents in accordance with project timelines
  • Manages the preparation, authoring and maintenance of regulatory submission documents pertaining to CMC data for global clinical trial and marketing applications, as well as post-marketing variations
  • Supports the evaluation of manufacturing changes for the potential impact on products
  • Provides expert review of CMC documentation supporting regulatory submissions and communications
  • Coordinates preparation of responses to queries from regulatory authorities, particularly focused on CMC
  • Maintains up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
  • Ensures conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments) for assigned programs
  • Provides regulatory advice to other functional areas
  • Participates in regulatory due diligence activities

Relationships:

  • Builds and maintains collaborative relationships with external business partners to achieve project regulatory goals
  • Develops and maintains collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines
  • Develops and manages relationships with external vendors and regulatory health authorities
  • Coordinates activities for meetings and conferences with FDA, EMA, and other regulatory authorities
  • Collaborates with regulatory colleagues to provide CMC expertise as needed

Minimum Skills/Knowledge Required:

  • 8+ years of drug development, including 5+ years of regulatory affairs CMC experience in the Biotech/Pharmaceutical industry; experience in small molecule, biologics and peptides is desirable.
  • Bachelor’s degree is required, preferably in chemistry or a closely related field; advanced degree is a plus
  • Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
  • Solid working knowledge of core processes: discovery, development, and manufacturing of small molecules and biologics
  • Experience with eCTD requirements and electronic submissions
  • Experience with international regulatory submissions and processes is a strong plus
  • Ability to work effectively across teams, functions and with outside partners
  • Excellent oral and written communication skills

We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.

Eiger BioPharmaceuticals is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Eiger has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment.  If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.

About Eiger BioPharmaceuticals, Inc.

Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious rare diseases.  The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.  All five Eiger rare disease programs have been granted FDA Breakthrough Therapy Designation.

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Job Description

The Director of CMC Project Management will provide critical support activities to multiple fast-moving late-stage development/commercialization programs. The major activities include establishing and refining business practices within CMC development, planning of project scope, timelines and budget, tracking of execution, facilitating communications within the team and externally, escalation of issues and knowledge management. There are regular interactions with external manufacturing sites, and with multiple service providers, suppliers and consultants. The position requires working knowledge of small and large molecules, analytical development and cGMP manufacturing workflows and practices. Successful candidate shall be an experienced technical project manager with a proven track record, who can operate in a multidisciplinary, collaborative, fast paced environment.

Responsibilities include, but not limited to:

  • Provide project management and leadership contribution to the CMC development function within the company, with ownership responsibility for all aspects of CMC development for multiple clinical late stage programs and commercial products.
  • Responsible for planning, coordinating and managing the activities of CMC development projects working closely with process, analytical, supply chain, regulatory and quality disciplines.
  • Perform project scope, budget and timeline assessments, scenario planning, sensitivity analysis, and the set up and tracking of projects.
  • Serve as project manager on cross functional project teams; communicate and collaborate with members from CMC, manufacturing, QC, QA, Regulatory Affairs, Clinical Development to achieve project goals and timelines.
  • Partner with CMC team members to ensure timely, efficient and effective communications and adequate progress on team activities to achieve project goals. Proactively identify and communicate issues, risks and mitigation plans to broader team and management. Conduct and communicate lessons learned to improve on CMC processes.
  • Provide meeting facilitation and documentation (agendas, documenting minutes, decisions, and action items).
  • Establish and refine business practices, including use of analytics and metrics to enhance efficiency and drive continuous improvement, implement use of tools and best practices, process mapping and refinement of workflows, prioritization, triaging of issues.
  • Organize project information using best practices and tools. Document decisions and lessons learned. Champion knowledge management culture within the CMC group.

Minimum Skills/Knowledge Required:

  • D., M.Sc. or B.Sc degree in Biotechnology or other relevant life science discipline with at least 12 years’ relevant industry experience, with at least 5 years’ experience in a project management role.
  • Experience participating in and leading cross functional teams.
  • Experience interfacing with internal operations groups and/or contract manufacturing organizations.
  • Demonstrated ability to apply and establish best practices of project management.
  • Knowledge and broad understanding of the CMC approaches, including cGMP operations requirements and relevant regulatory guidelines.
  • Excellent written and verbal communication skills.
  • Ability to work in a fast-paced environment, to multitask and manage multiple projects.
  • Ability to independently and rapidly evaluate impact of new information, anticipate solutions, identify the need for decisions, frame issues, inform impacted stakeholders and drive resolution using inclusive, collaborative approach and sound judgement.

We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.

EOE

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

About Eiger BioPharmaceuticals, Inc.

Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.

Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.

Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Responsibilities include, but not limited to:

  • Responsible for overseeing the planning and execution of all pharmacovigilance activities in the US and EU for marketed medications and those in-development including oversight of PV vendor in relation to the contracted PV activities.
  • Ensures the successful transition of drugs in the development-stage through to the commercial marketplace.
  • Responsible for setting-up contracts with various PV providers and CROs.
  • Accountable for working with PV vendor to ensure the completion of pharmacovigilance aggregate reports (e.g. DSUR, PBRER) and to meet global/local reporting obligations. Oversees updates to safety components of drug labels.
  • Accountable for the development and execution of safety management plans for the Company’s products.
  • Provides training and guidance to other functions to ensure the Company is compliant with all pharmacovigilance requirements.
  • Ensures timely submission of safety information to relevant health authorities and other external stakeholders.
  • Provides safety information as needed for study reports, protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA, Health Authority requests and product labeling.
  • Oversees the technical and scientific support for safety surveillance and signal detection activities for the Company’s products.
  • Responsible for ensuring that routine Safety Management Team (SMT) meetings are scheduled for team’s assigned products and overseeing outcomes.
  • Ensures appropriate stakeholder representation and input at SMT.
  • Ensures all data is appropriately compiled and presented at SMT for team review
  • Liaises with SMT chair to facilitate communication and support for decisions resulting from the SMT (e.g. update of RMPs, labeling, regulatory notifications).
  • Responsible for oversight of the development and maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk minimization activities for team’s assigned products in conjunction with QPPV vendor.
  • Provides oversight to ensure that all RMP commitments are efficiently tracked.
  • Provides oversight to ensure that RMP is updated as needed.
  • Collaborates with internal and external stakeholders outside of PV. Represents PV department in cross-functional meetings and additional activities to support clinical developmental programs and commercially available medications.
  • Provides guidance to any Drug Safety Monitoring Board if applicable.
  • Demonstrates subject matter expertise and understanding of all clinical and post-marketing activities and PV requirements for team’s assigned products.
  • Evaluates and improves current processes, as needed, to enhance medical surveillance and risk management process to ensure best practices.
  • Takes appropriate role in PV audits and inspections. Participates in audit preparedness activities and serves as subject matter expert during regulatory inspections in collaboration with team members.
  • Contributes to internal and external PV meetings based on specific topics.
  • Provides guidance, training, and oversight to pharmacovigilance vendor supporting pharmacovigilance activities, as needed.
  • Participates in new study initiation to ensure PV requirements are met including but not limited to: safety reporting, query resolution, SAE reconciliation, un-blinding process, and safety reporting training.

Minimum Skills/Knowledge Required:

  • Bachelor’s degree in health-related discipline or equivalent. RN, R.Ph., or Pharm D. degree is highly preferred. Master of Public Health also considered appropriate.
  • Minimum of 7 years of progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 1 of which were spent in a leadership/managerial role.
  • Experience in signal detection, safety surveillance, risk mitigation and risk management.
  • Expert knowledge of relevant food and drug administration (FDA), European union (EU) and international conference on Harmonization (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
  • Extensive working knowledge of medical terminology and medical dictionary of regulatory activities (MedDRA).
  • Experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality a plus.
  • Excellent verbal and written communication and skills.
  • Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Ability to influence without direct authority.
  • Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations.
  • Ability to write reports, business correspondence, and procedures.

We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.

Eiger BioPharmaceuticals is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Eiger has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment.  If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.

About Eiger BioPharmaceuticals, Inc.

Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious rare diseases.  The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.  All five Eiger rare disease programs have been granted FDA Breakthrough Therapy Designation.

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Position Overview

As one of the first colleagues to join the Eiger Medical Affairs field team, you will serve as a founding member of an expanding group that will be critical to the company’s future success. Our MSL field team will be responsible for helping to create and shape the foundation of Eiger’s Medical Affairs initiatives which will include the introduction of our company and our late-stage development programs, with a primary focus on HDV, building a key opinion leader network, developing and maintaining professional relationships with allied healthcare personnel and all external customers, and providing comprehensive medical and scientific support aligned to Eiger development and post approval initiatives. You will work collaboratively with the entire Eiger organization across all functional areas to ensure accurate and appropriate dissemination of information related to our pipeline and therapeutic areas critical to achievement of corporate objectives.

Responsibilities include, but not limited to:

  • Develop and maintain scientific and medical expertise in disease states of strategic importance to the Eiger pipeline and corporate objectives;
  • Identify, develop, and maintain peer-to-peer relationships with current and future Key Opinion Leaders (KOLs), Investigators, Allied Health Personnel;
  • Deliver clinical presentations, product presentations, and information in response to clinicians, investigators and sites, academic settings, community and healthcare provider settings, payors;
  • Report learnings and key insights from the field back into the Eiger medical team and broader organization when appropriate to support competitive awareness;
  • Support Eiger clinical development activities, including site interaction when necessary, to facilitate ongoing or planned development initiatives, including patient enrollment;
  • Develop and execute field regional plans in alignment with corporate strategic objectives and plans;
  • Support the development, implementation, and execution of medical strategies and tactics (e.g. convention activities, advisory boards, congress symposia, regional KOL plans, and speaker programs) in close coordination with corporate objectives and plans.

Minimum Skills/Knowledge Required:

  • Completed Pharm D, MD, PhD, MS in a scientific discipline preferred
  • 5+ years of total pharmaceutical industry experience preferred
  • 5+ years of post-professional degree practice or relevant experience (clinical practice, academic research, clinical operations, medical affairs) preferred
  • Experience in literature review, analysis, and medical writing
  • Hands on mentality & team-player
  • Experience in Hepatology, Gastroenterology, and or rare diseases preferred
  • Self-motivated, self-reliant, and able to work independently
  • Knowledge of legal, regulatory, and compliance regulations and guidelines relevant to industry interactions with health-care professionals
  • Ability to effectively partner and maintain relationships with external stakeholders
  • Ability to work cross functionally
  • Excellent communication skills
  • Ability to travel up to 50-60% of the time is a must

Title(s): Flexible, to be developed based on experience and fit within broader organization plan.

We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.

EOE

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

About Eiger BioPharmaceuticals, Inc.

Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.

Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.

Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Job Description

The Senior Director of Product Development will be responsible for all aspects of formulation and process development from DOEs, process development, technology transfer/scale up and process validations for drug products, devices and commercial manufacturing. The Senior Director will also serve as CMC Lead of Eiger products and projects with the responsibility of authorship of the CMC sections of global regulatory submissions for both clinical and to be marketed products. This role is a broad-based, strategic position requiring an established leader with in-depth scientific and technical knowledge of biological product development.

Responsibilities include, but not limited to:

  • Provide strategic oversight on product development activities including formulation, process development, process characterization, scale-up, technology transfer and process validation
  • Oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions.
  • Serve as SME and participate in strategy guidance for CMC related regulatory interactions
  • Collaborate effectively with Quality to ensure compliance with GMP guidelines at all times and make recommendations to ensure conformity with quality specifications.
  • Oversee and manage process characterization and process validation studies, as well as technology transfer for all phases of development and commercial products.
  • Manage external CMO activities, ensuring close partnership through open and transparent communications, scientific and strategic understanding, and attention to Eiger priorities
  • Apply sound scientific and engineering criteria to design and develop manufacturing processes, identify and execute process improvement / optimization strategies, and ensure successful commercial scale-up for all programs
  • Lead CMC projects and represent CMC in Project Development meetings, as required
  • Develop resourcing strategies, allocate budget for department to meet company objectives and efficient operations
  • Author of and/or reviews batch records, change controls, process validation and other technical documents.

Minimum Skills/Knowledge Required:

  • Ph.D., M.Sc. or B.Sc degree in Biotechnology or other relevant life science discipline with at least 12 years’ relevant industry experience, with at least 5 years’ experience in a Product and Process Development role.
  • Experience participating in and leading cross functional teams.
  • Experience interfacing with internal operations groups and/or contract manufacturing organizations.
  • Knowledge and broad understanding of the CMC approaches, including cGMP operations requirements and relevant regulatory guidelines.
  • Excellent written and verbal communication skills.
  • Ability to work in a fast-paced environment, to multitask and manage multiple projects.
  • Ability to independently and rapidly evaluate impact of new information, anticipate solutions, identify the need for decisions, frame issues, inform impacted stakeholders and drive resolution using inclusive, collaborative approach and sound judgement

We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.

EOE

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

About Eiger BioPharmaceuticals, Inc.

Eiger is a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases.

Eiger’s lead clinical programs are focused on the development of foundational therapies for Hepatitis Delta Virus (HDV) infection, the most serious form of viral hepatitis, with two complementary HDV treatments. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, type III, well-tolerated interferon entering Phase 3.

Zokinvy® for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approved product. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA).

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Job Description

The Senior Director, of Regulatory Affairs, will be responsible for developing, planning, and coordinating regulatory submissions in line with program strategies and cross-functional initiatives. He/she is expected to lead team efforts for major filing activities for global development programs. This individual will represent Regulatory Affairs on cross-functional teams, provide guidance on regulatory strategy and tactics, and coordinate with key stakeholders, as required. Organize/manage submissions to health authorities, including IND/CTAs, IND/CTA amendments, NDAs/MAAs, designation applications, meeting packages, annual reports, etc. Involve in authoring of regulatory documentation. This person may have help implement the organization's advertising and promotions regulatory operations including the filing of 2253s and prescribing information files.

Responsibilities include, but not limited to:

  • Manage key regulatory affairs personnel with the objective of providing ongoing development opportunities for their direct reports.
  • Manages/oversees regulatory workflow between departments as well as CROs as required. Serve as primary regulatory contact for submission vendors, provide general oversight to CRO regulatory operation team, and organize/manage the regulatory submissions.
  • Represents RA at project team meetings and provide expertise on regulatory matters. With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and safety.
  • Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects. Oversee development of submission plan and associated timelines with regulatory operations.
  • Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad, including INDs/CTAs and amendments, BLA/NDA/MAA and supplements, designation/special program application, meeting requests and briefing documents. annual reports, safety reports, etc.
  • Ensure regulatory submissions and activities are maintained in compliance with regulatory requirements. Prepare and maintain regulatory archive for the company.
  • Review promotional, corporate and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies. Ensure all 2253s are filed.
  • Develop and maintain current regulatory knowledge. Collaborate with external parties, i.e., partner companies, regulatory consultants, and CROs as required.

Minimum Skills/Knowledge Required:

  • Minimum 8 years of experience in the biotechnical or pharmaceutical industry and a minimum of 6 years experience in a Regulatory capacity.
  • B.S., advanced degree in life sciences preferred (PhD, PharmD, NP/PA, MD, MS, MPH)
  • Regulatory Affairs Certified
  • Experience and knowledge with eCTD. Specialized knowledge of regulatory activities including but not limited to submissions to HAs. Experience in preparation of INDs/CTAs (required) and NDA/MAA/BLA (desirable), supportive amendments and supplements (manufacturing, nonclinical, clinical), annual report, meeting packages, etc. Experience in advertisement and promotion review is a plus.
  • Ability to learn and assimilate scientific information. Ability to understand study results, to help in its interpretation for regulatory positions and strategy.
  • Experience with document formatting and publishing documents in Adobe Acrobat Professional is required. Experience in using StartingPoint template is a plus.
  • Working knowledge and understanding (application of knowledge/experience) of FDA/EMA and ICH regulatory guidance and regulations for drug therapeutics. Knowledge/experience with regulatory requirements for other regions also desirable.
  • Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle.

We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.

EOE

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

About Eiger BioPharmaceuticals, Inc.

Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious rare diseases.  The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.  All five Eiger rare disease programs have been granted FDA Breakthrough Therapy Designation.

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]

Job Description

The Trial Master File (TMF) Specialist is responsible for the day-to-day management of the TMF, including support tasks related to the set-up, maintenance, close out of the TMF and oversight of the review and approval of TMF documents. This role has a strong focus on ensuring that document management operations are performed with adherence to standard operating procedures (SOPs) and ICH GCP/regulatory guidelines and ensuring the TMFs are always inspection ready.

Responsibilities include, but not limited to:

  • Process study documentation in accordance with Standard Operating Procedures (SOPs), GCP, ICH guidelines and study specific TMF Plans.
  • Support the set-up, maintenance, and closure of TMF repositories.
  • Support documentation collection activities, including:-
    • Document scanning and indexing for trial using an electronic TMF
    • Document filing for trials using a paper TMF
  • Perform quality review of documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified 
  • Maintain compliance with departmental quality performance and utilization targets 
  • Complete administrative tasks (e.g., status reports) as requested
  • Maintain compliance with company requirements (e.g., time tracking, training)
  • Participates in preparation/reconciliation of TMF documentation related to audits, and shipments.
  • Collaborate with functional area representatives to help ensure submission-readiness and inspection-readiness of TMFs, as needed
  • Authoring and reviewing internal and external TMF-related SOPs and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes, risk-based QC processes, etc.).
  • Participates in study specific training as required. 
  • For Paper documents, responds promptly to each request received for a project document or project file, ensures timely and appropriate delivery to the requestor, and timely and accurate re-filing upon return. Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room
  • Ensures the security and compliance of all documents related to active and archived projects.

Minimum Skills/Knowledge Required:

  • Undergraduate degree in scientific/regulatory field or Business Management
  • Minimum of 5 years demonstrable records management experience.
  • Experience in a clinical trials environment highly preferred
  • Familiarity with electronic TMF system preferred
  • Strong verbal, written and organizational skills with a team-oriented approach.  
  • Ability to handle and prioritize multiple tasks to meet deadlines in a dynamic environment.
  • Proficiency in Microsoft Office Suite and Adobe Acrobat.
  • Knowledge and familiarity with industry workgroups and initiatives such as DIA Records Management Community (TMF Reference Model)
  • Knowledge of applicable TMF and Document Management regulations and guidelines such as MHRA and EMA.
  • Working knowledge of Good Clinical Practice (GCP).

TRAVEL REQUIRED

  • Minimal travel may be required (up to 10%)

We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.

EOE

The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

About Eiger BioPharmaceuticals, Inc.

Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious rare diseases.  The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.  All five Eiger rare disease programs have been granted FDA Breakthrough Therapy Designation.

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Please submit your resume to:

[email protected]