Company Overview:

Inozyme Pharma,Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical companydeveloping novel therapeutics for the treatment of diseases of abnormalmineralization impacting the vasculature, soft tissue, and skeleton. Throughour in-depth understanding of the biological pathways involved inmineralization, we are pursuing the development of therapeutics to address theunderlying causes of these debilitating diseases. It is well established thattwo genes, ENPP1 and ABCC6, play key roles in a critical mineralization pathwayand that defects in these genes lead to abnormal mineralization. We areinitially focused on developing a novel therapy, INZ-701, to treat the raregenetic diseases of ENPP1 and ABCC6Deficiencies. INZ-701 is currently in Phase1/2 clinical trials for the treatment of ENPP1 Deficiency and ABCC6 Deficiency.

Position Overview:

As the Senior Manager/Associate Director ofRegulatory Strategy, you will play a critical role in driving the developmentand execution of regulatory strategies for our rare disease therapeuticprograms. Your expertise and leadership will be instrumental in navigating thecomplex regulatory landscape and ensuring compliance with regulatoryrequirements.

You will develop and implement US regulatorydevelopment strategy leading to successful registration and life-cyclemanagement of unique and technologically complex products serving patients withrare diseases and unmet medical needs. You will collaborate closely withcross-functional teams, including Clinical Development, Medical Affairs,Quality Assurance, and Commercial, to achieve regulatory milestones and supportsuccessful product development and commercialization.

Responsibilities:

Provides support to regulatory affairsreviewers for due diligence initiatives, including opportunity and riskassessment.

1. Develop and implement globalregulatory strategies for rare disease therapeutic programs, ensuring alignmentwith corporate objectives and regulatory requirements.

2. Accountable for preparation andexecution of regional aspects of the regulatory global strategy. Can includesetting direction for junior staff to execute regional regulatory tasksaccording to strategy.

3. Provide strategic guidance andleadership to cross-functional teams on regulatory requirements, agencyinteractions, and submission strategies throughout the product lifecycle.

4. Lead the preparation, review, andsubmission of high-quality regulatory documents, including INDs, BLAs, NDAs,and other relevant filings, ensuring compliance with applicable regulations andguidelines.

5. Monitors the development of newregulatory requirements or guidance documents and advises product teams of theimpact on the business or development programs

6. Proactively monitor and analyzeregulatory trends, guidelines, and developments related to rare diseasetherapies, and provide strategic recommendations to senior management.

7. Serve as the primary point of contactfor regulatory agencies (FDA, EMA, etc.), representing the company ininteractions, meetings, and negotiations.

8. Collaborate with cross-functionalteams to develop and execute regulatory communication plans, includingscientific advice meetings, pre-submission meetings, and regulatory authorityinteractions.

9. Build and maintain effectiverelationships with key stakeholders, including regulatory agencies, key opinionleaders, and external consultants.

10. Stay current with evolving regulatoryrequirements and best practices, and ensure compliance with all applicableregulations, guidelines, and industry standards.

11. Provide regulatory guidance andsupport to internal teams to ensure compliance with regulatory obligationsthroughout the organization.

12. Mentor and develop regulatory teammembers, fostering a culture of excellence, collaboration, and continuouslearning.

Qualifications:

1. Advanced degree (Ph.D., Pharm.D., orequivalent) in life sciences or a related field.

2. Minimum of 6 years of regulatoryaffairs experience in the biopharmaceutical industry, with a focus on rarediseases and orphan drug development.

3. Strong knowledge of global regulatoryrequirements and guidelines for drug development and registration, includingFDA and EMA regulations.

4. Proven track record of successfullyleading regulatory strategy and submissions for rare disease therapeuticprograms.

5. Experience with regulatoryinteractions, including FDA meetings (pre-IND, end-of-Phase 2, pre-NDA, etc.)and EMA scientific advice procedures.

6. Demonstrated ability to providestrategic regulatory guidance and effectively communicate complex regulatoryinformation to cross-functional teams and senior management.

7. Strong leadership and peoplemanagement skills, with the ability to motivate and develop high-performanceteams.

8. Excellent written and verbalcommunication skills, with the ability to influence and negotiate with internaland external stakeholders.

9. Ability to work effectively in afast-paced, dynamic environment with a high degree of flexibility andadaptability.

10. Regulatory affairs certifications(RAC) or other relevant professional certifications are a plus.

Apply now

RESUME

Upload Your Resume

Max file size 10MB.

Uploading...

fileuploaded.jpg

Upload failed. Max size for files is 10 MB.

Thank you! Your job applicant submission has been received!

Oops! Something went wrong while submitting the form.

EEOC Statement:

To all recruitment agencies: Inozyme Pharma, Inc. does not accept agency resumes. Please do not forward resumes to our job's alias, Inozyme employees or any other organization location. Inozyme is not responsible for any fees related to unsolicited resumes.

Clinical Trial Associate

We are seeking a highly motivated individual to join our team as a Clinical Trial Associate (CTA) to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). The individual is an integral member of the study team who will facilitate operational efficiencies in clinical trials, guided by SOPs and ICH-GCP.

Prior to joining, your experience will have been from a clinical research organization, hospital or large medical specialty clinic, or work at another biopharma. You will be familiar with clinical data and clinical trial terminology, be able to read standard medical abbreviations that are used in the world of medical practice and clinical studies. You will have familiarity with FDA regulations, GCP, essential study documents, and key study activities such as; tracking patient screening and enrollment, clinical laboratory sample collection, regulatory documents, and study team communications. Problem solving skills will be used daily. And did we mention - being highly organized is essential.

Essential Duties and Responsibilities:

* Assist with the setup, maintenance and oversight of the Trial Master Files (TMF), including TMF plan.

* Support the cross-functional team with the circulation of documents for cross functional review, filing of documents in study working folders, and collation and QC of documents for the TMF submission.

* Assist the clinical project manager/lead and study team with the drafting of meeting agendas, meeting minutes, and managing meeting logistics (meeting room, calendar invites).

* Assist in the planning and preparation for internal/external meetings (e.g. CRO Face-to-face meetings, investigator meetings, conferences).

* Ensure the completeness and accuracy of essential regulatory documents for study drug shipment.

* Assist the Clinical Operations team with preparing and reviewing documentation (e.g. study manuals and plans) for assigned trials.

* Access study systems e.g. clinical database, eTMF, CTMS, etc. to support study oversight activities.

* Assist with the tracking and oversight of laboratory sample collection, processing and shipping information.

* Assist the study team with the update and maintenance of study status trackers and status reports.

* Develop and maintain study team roster and vendor contact lists.

* Assists with the development of study materials, e.g. study newsletters, study templates etc., as needed.

* Source and distribute study supplies, as needed.

* Maintain study tracking tools and study calendars.

* Assist with tracking invoices and obtaining internal approvals for payments; work with CPM to verify accuracy of information prior to approval.

* Assist with the creation and circulation of Purchase Orders for approval.

* Assist the study team with preparing study updates for internal and external stakeholders.

* Balance competing and evolving priorities across trials.

* Collaborate closely with internal and external stakeholders to support the execution of clinical studies.

* Other duties as assigned.

Desired Skills & Experience:

* BS / MS or equivalent

* 2-3 years' experience in clinical research at a hospital, CRO, or biopharmaceutical company is desirable.

* Superior understanding of Microsoft Office

* Aptitude for organizational detail

* Capacity to complete tasks independently in a highly regulated environment

* Flexibility to function well within a team environment and within condensed timelines.

* Excellent written and verbal communication skills

* Strong interpersonal skills

* Basic understanding of learn FDA regulatory requirements and good clinical practice (GCP)

Apply now

RESUME

Upload Your Resume

Max file size 10MB.

Uploading...

fileuploaded.jpg

Upload failed. Max size for files is 10 MB.

Thank you! Your job applicant submission has been received!

Oops! Something went wrong while submitting the form.

EEOC Statement:

To all recruitment agencies: Inozyme Pharma, Inc. does not accept agency resumes. Please do not forward resumes to our job's alias, Inozyme employees or any other organization location. Inozyme is not responsible for any fees related to unsolicited resumes.

Part-Time Office Assistant

We are seeking a highly motivated and detail-oriented Part-Time Office Assistant to join our G&A team. In this role, you will be pivotal in ensuring the efficient day-to-day operations of our office, providing exceptional administrative, clerical, and facilities support, while contributing to our positive work environment. This role will be hourly and approximately 16-20 hours per week.

Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological pathways involved in mineralization, we are pursuing the development of therapeutics to address the underlying causes of these debilitating diseases. It is well established that two genes, ENPP1 and ABCC6, play key roles in a critical mineralization pathway and that defects in these genes lead to abnormal mineralization. We are initially focused on developing a novel therapy, INZ-701, to treat the rare genetic diseases of ENPP1 and ABCC6Deficiencies. INZ-701 is currently in Phase 1/2 clinical trials for the treatment of ENPP1 Deficiency and ABCC6 Deficiency.

Responsibilities:

* Maintain a well-stocked inventory of office supplies and equipment, proactively placing orders and restocking on a weekly basis.

* Assist with clinical shipping needs.

* Maintain copier supplies and shredding services.

* Responsible for ordering Chaser Tickets for adequate employee commuter reimbursement.

* Coordinate lunch orders for company Team Weeks and BoD Meetings.

* Set up conference rooms for meetings, ensuring they are well-equipped and ready for use.

* Identify and address minor maintenance issues in the office or coordinate with facilities personnel for repairs.

* Ensure a clean, organized, and professional environment is maintained throughout the office

* Demonstrate initiative and adaptability, taking on a variety of other adhoc duties, as assigned, to contribute to the team's overall efficiency.

Qualifications:

* 1-2 years of experience in a similar clerical, facilities, or assistant-type role, with a proven track record of success in organization and communication.

* Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) is essential.

* Possess excellent written and verbal communication skills, with the ability to articulate information clearly and concisely to a diverse audience.

* Highly organized and detail-oriented, with the ability to prioritize tasks effectively, manage time efficiently, and thrive in a fast-paced environment.

* A self-starter with the ability to work independently while also being a team player who enjoys collaborating with others.

* Possess a positive attitude, a willingness to learn, and a desire to contribute to a growing and dynamic company.