Manager, Quality Assurance – Irvine, CA

Improving quality-of-life through innovations in urology.

Urovant Sciences (Nasdaq: UROV) is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions and improving the way providers and their patients confront urologic diseases that are difficult to treat.

Every employee at Urovant plays an integral role to our success.  We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve.  Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.

Urovant’s lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB).  In addition to OAB, vibegron is being evaluated for two additional potential indications:  the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of abdominal pain associated with irritable bowel syndrome (IBS).

Urovant’s second investigational product candidate, URO-902, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.

The Manager, Quality Assurance is responsible for contributing through development, implementation, and management of Urovant’s Quality Systems for R&D.

The position is based at Urovant’s site in Irvine, CA and reports to the Director of Quality.

 

Responsibilities include:

  • Manage SOP and regulated documentation systems and support the preparation and or review of new, revised SOP, test methods, and validation documents.
  • Perform GMP Batch Release of clinical, validation, and commercial product.
  • Support health authority inspections (GCP, GMP, GLP) and vendor qualification activities, including conducting or participating in supplier and internal audits.
  • Administrator of, and primary contact for Urovant R&D’s CAPA program. Provide leadership in corrective action implementation and drive follow-up on audit issues until completion.
  • Provide quality & regulatory technical guidance to internal R&D functions and external vendors (e.g. CRO, CMO).
  • Contribute to development and maintenance of the Change Control and Product Quality complaints systems.
  • Identify the need for investigations due to deviations from written procedures, review investigations into non-conformance incidents/deviations, and recommend disposition of the affected product/component.
  • Develop and provide quality metrics and trend reports for functions and leadership.
  • Perform quality and regulatory related training.

 

Education and Experience

  • Bachelor’s degree; advanced/graduate degree preferred.
  • 3+ years of experience in Quality or Quality-related roles in the Pharma/Medical Device industry
  • Experience with internal audits and health authority inspections (GCP, GMP, GLP)

 

Essential Skills and Abilities

  • Ability to work in a team environment
  • Strong project management skills and ability to perform/prioritize multiple tasks in a fast-paced, deadline-driven environment with limited supervision
  • High level interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner
  • Excellent written and oral communication skills
  • Highly proficient using Microsoft Word, Visio, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems
  • Ability to prioritize tasks and work across locations and time zones
  • Exceptional communication skills, both verbally and in writing
  • A commitment to collaborative teamwork and the maintenance of a professional culture based on trust and mutual respect

 

 

Senior Director, Regulatory Affairs

Improving quality-of-life through innovations in urology.

Urovant Sciences (Nasdaq: UROV) is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions.  Urovant is a company with an entrepreneurial focus on improving the way providers and their patients confront urologic diseases that are difficult to treat.

Every employee at Urovant plays an integral role to our success.  We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve.  Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.

Urovant’s lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist is being developed for overactive bladder (OAB).  In addition to OAB, vibegron is being evaluated for two additional potential indications:  the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of abdominal pain associated with irritable bowel syndrome (IBS).

Urovant’s second investigational product candidate, URO-902, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.

 

Position Description:

The Senior Director of Regulatory Affairs, within Urovant’s Regulatory Affairs and Quality organization, is responsible for development and implementation of regulatory affairs strategy as a member of multi-disciplinary pharmaceutical product development teams.

 

Responsibilities include:

  • Represent the regulatory affairs function on assigned cross-functional small molecule and biologic pharmaceutical product development teams.
  • Develop and implement global regulatory affairs strategy in accordance with applicable regulations/guidelines (e.g. US FDA, EMA, ICH, etc.) (for clinical trials and registration) for supported programs.
  • Plan, prepare, author, and/or review submissions (e.g. IND, CTA, BLA, NDA, MAA) to health authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products.
  • May serve as primary liaison with FDA (and other health authorities, as appropriate) for day-to-day interactions.
  • Coordinate and prepare responses to requests for information from health authorities.
  • Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings with health authorities.
  • Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs.
  • Participate in due diligence evaluations of potential in-license/partnering opportunities.

The Senior Director,  Regulatory Affairs should be able to travel, including international travel, for at least 30% of time, depending on business needs.

 

Education and Experience

  • Bachelor’s degree required, with an advanced scientific degree (PhD, PharmD, MD) strongly preferred
  • At least 6 years’ experience in Regulatory Affairs

 

Essential Skills and Abilities

  • Regulatory Affairs experience in therapeutic areas of company focus; urology, gastroenterology, and oncology
  • Regulatory Affairs experience with multiple therapeutic modalities; small molecules, biologics, gene therapies, drug/device combination products, and therapeutic devices
  • Ability to work effectively in a cross-functional team environment
  • Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables
  • Excellent written and oral communication skills
  • Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems.
  • Strong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budget
  • A commitment to collaborative leadership, management, teamwork, delegation and the maintenance of a professional culture based on trust and mutual respect

Senior Director, Pharmacovigilance

Improving quality-of-life through innovations in urology.

Urovant Sciences (Nasdaq: UROV) is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions.  Urovant is a biotechnology company with an entrepreneurial focus on improving the way providers and their patients confront urologic diseases that are difficult to treat.

Every employee at Urovant plays an integral role to our success.  We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve.  Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.

Urovant’s lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB).  In addition to OAB, vibegron is being evaluated for two additional potential indications:  the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of abdominal pain associated with irritable bowel syndrome (IBS).

Urovant’s second investigational product candidate, URO-902, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.

The Senior Director, Pharmacovigilance is responsible for all aspects of Pharmacovigilance within the organization.

The position is based at Urovant’s site in Irvine, CA and reports to the Chief Medical Officer.

 

Responsibilities include:

  • Leadership and organization of the Pharmacovigilance function and all safety aspects in clinical trials in collaboration with all functions and vendors for all clinical development programs and establish the procedures for post-marketing pharmacovigilance.
  • Provides input and responsible for the safety aspects of periodic regulatory safety reports, the Investigator’s Brochures, Informed Consents, clinical study protocols, clinical study reports, safety sections of the INDs or IMPDs or other regulatory documents, safety aspects of the CTD modules, and regulatory labels and other documents, including Medical Monitoring plans and Safety Management Plans.
  • Develop the budgets and updates and management of contracts for the Pharmacovigilance function with the safety vendors in collaboration with the Head of Project Management, Finance and Core and Clinical Development Team Leaders and other relevant functions.
  • Establish and oversee the Safety Scientist function
  • Involvement in business development activities and due diligences and working with Business Partners.
  • Involved in internal process improvement activities such as SOPs or guidance documents, as assigned.
  • Supervise direct reports, including review of performance and working on training needs for further development of the direct reports.

 

Education and Experience

  • MD degree required.
  • 10+ years of experience in global clinical safety for development projects and Pharmacovigilance of marketed products.

 

Essential Skills and Abilities

  • Leadership and collaborative capabilities for cross functional teams.
  • Good organizational skills.
  • Excellent communication skills, both verbally and in writing.
  • Strong presentation skills, including presentations to senior management, external audiences and experts.
  • Ability to work across locations and time zones.
  • Ability to work on several projects and assignments at the same time and also prioritize tasks.
  • Strong financial business acumen and analytical skills.
  • Strong interpersonal skills and ability to confront issues with vendors and cross-functional team members for a win-win outcome.
  • Thorough understanding of ICH Good Pharmacovigilance Practices and Good Clinical Practices, including broad application of knowledge in different therapeutic areas.
  • Knowledge of MedDRA and Argus or similar applications and systems.
  • A commitment to collaborative leadership, management, teamwork, delegation and the maintenance of a professional culture based on trust and mutual respect.
  • 30% travel, including international travel, depending on business needs.

 

Director, Medical Communications and Information

Improving quality-of-life through innovations in urology

Urovant Sciences (Nasdaq: UROV) is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions.  Urovant is a nimble company with an entrepreneurial focus on improving the way providers and their patients confront urologic diseases that are difficult to treat.

Every employee at Urovant plays an integral role to our success.  We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve.  Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.

Urovant’s lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist is being evaluated for overactive bladder (OAB).  In addition to OAB, vibegron is being evaluated for two additional potential indications:  the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of abdominal pain associated with irritable bowel syndrome (IBS).

Urovant’s second investigational product candidate, URO-902, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.

 

Position Description:

The Director, Medical Communications and Information (Med Comm & Info) is responsible for directing and leading the Medical Communications (Publications) functions and functional capabilities of Medical Information within Medical Affairs.

 

Responsibilities include: 

 

  • Overseeing the development/management of Urovant’s publications strategy, plan and corresponding scientific platform, including content for abstracts, manuscripts, congress presentations, monographs, advisory board meetings, slide decks, etc.
  • Overseeing Medical Information function and Medical Communications vendor/agency selection, training and management
  • Developing strategic direction, implementation and oversight of medical information services (e.g. accessing scientific literature, maintaining a repository of relevant articles to support the company, developing standard response letters and Medical Affairs tools, responding to medical inquiry escalations, and management of the Medical Information Call Center)
  • Participating in MLR (medical/legal/regulatory) review of promotional and medical materials, as needed
  • Participating and collaborating in cross-functional meetings
  • Planning for medical congresses
  • Hiring, training, coaching, performance review, and professional development of direct reports
  • Managing the Medical Communications and Information department budget

 

The Director, Medical Communications and Information position should be able to travel, including international travel, for at least 20% of time, depending on business needs.

 

Education and Experience

  • MD/DO, PharmD, or PhD in scientific field required
  • 8+ years of Medical Affairs experience within the pharmaceutical or biopharmaceutical industry
  • 5+ years of MSL experience, 3+ years of line management experience
  • CMPP certification a plus
  • Urology experience preferred
  • Knowledge of FDA regulations, ICH guidance, and GCP regulations
  • Knowledge of drug development, scientific communications and the scientific publication process (GPP)

 

Essential Skills and Abilities

 

  • Proficient organizational skills with the ability to manage multiple complex projects/tasks at the same time
  • Excellent written and oral communication skills
  • Highly proficient using Microsoft Word, Visio, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems
  • Ability to prioritize tasks and work across locations and time zones
  • A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect
  • Assists the VP, Medical Affairs in developing Medical Affairs strategy that encompasses the Medical Communications and Information (Med Comm & Info) functions. Oversees the Med Comm & Info department and provides strategic oversight of the development of high quality medical and scientific collateral
  • Participates in selection, contract negotiation, training and supervision of the work of vendors for various Medical Affairs activities, including the Medical Information Call Center, medical advisory boards, medical tool development, and medical writing; ensures work is high quality and developed on time and on budget
  • Represents Med Comm & Info as an integral member of cross-functional teams, including commercial, legal, regulatory, managed markets and clinical development
  • Hires, trains, coaches and develops Med Comm & Info team; includes setting measurable goals and ensuring team members execute successfully against the Med Comm & Info strategy
  • Manages the Medical Comm & Info department budget

Director, Medical Science Liaisons (MSLs)

Improving quality-of-life through innovations in urology.

Urovant Sciences (Nasdaq: UROV) is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions.  Urovant is a nimble company with an entrepreneurial focus on improving the way providers and their patients confront urologic diseases that are difficult to treat.

Every employee at Urovant plays an integral role to our success.  We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve.  Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.

Urovant’s lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist is being evaluated for overactive bladder (OAB).  In addition to OAB, vibegron is being evaluated for two additional potential indications:  the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of abdominal pain associated with irritable bowel syndrome (IBS).

Urovant’s second investigational product candidate, URO-902, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.

 

Position Description:

The Director, Medical Science Liaisons (MSLs) is responsible for providing leadership and strategic direction to a team of high performing urology and Managed Markets/Long-term care medical science liaisons (MSLs). The Director, MSLs is a high visibility leadership role with ultimate accountability for the effectiveness and compliance of scientific exchange conducted by the MSL teams to meet the needs of healthcare professionals in a variety of settings, including clinicians, researchers, advocacy groups, and other external and internal stakeholders.

 

Responsibilities include:

 

  • Managing Medical Science Liaison (MSL) and Managed Markets/Long Term Care MSL (MM/LTC MSL) teams
  • Provides oversight and leadership that ensures effective and compliant interactions between MSLs and internal/external stakeholders. Ensures medically/scientifically balanced and compliant communications on Urovant commercialized products, development programs and disease states
  • Hires, trains, coaches and develops the field-based medical team; includes setting measurable goals and ensuring team members execute successfully against the field medical strategy
  • Assists the VP, Medical Affairs in developing Medical Affairs strategy that encompasses the field-based medical organization
  • Organizes and communicates to cross-functional stakeholders the insights the MSL team gains about competitive landscape, unmet needs of researchers, physicians and advocacy groups; develops actionable plans to address insights
  • Oversees and participates in the creation and dissemination of effective, compliant, medically-sound information tools for use by MSLs to support the safe and effective use of company marketed products
  • Contributing to the development of the Medical Affairs strategy, and creating and aligning the field medical strategy with the overall scientific platform
  • Identifying and creating medical tools for the field-based medical teams
  • Setting measurable goals and ensuring implementation and execution of medical strategies through the field based MSL teams
  • Providing field insight reports and contributing to actionable strategy plans
  • Participating and collaborating in in cross-functional meetings
  • Participating in medical and scientific congresses
  • Hiring, training, coaching, performance review, and professional development of direct reports
  • Managing the field-based medical budget

 

The Director, Medical Science Liaisons (MSLs) should be able to travel, including international travel, for at least 60% of time, depending on business needs.

 

Education and Experience

  • MD/DO, PharmD, or PhD in scientific field required
  • 8+ years of Medical Affairs experience within the pharmaceutical or biopharmaceutical industry
  • 5+ years of MSL experience, 3+ years of line management experience
  • Field-based MSL management experience preferred
  • Urology experience preferred
  • Business degree (MBA) preferred
  • Knowledge of FDA regulations, ICH guidance, and GCP regulations
  • Possession of a valid state Driver’s License

Essential Skills and Abilities

 

  • Proficient organizational skills with the ability to manage multiple complex projects/tasks at the same time
  • Excellent written and oral communication skills
  • Highly proficient using Microsoft Word, Visio, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems
  • Ability to prioritize tasks and work across locations and time zones
  • A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect

Associate Manager, Regulatory Advertising Promotion

Improving quality-of-life through innovations in urology.

Urovant Sciences (Nasdaq: UROV) is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions.  Urovant is a nimble company with an entrepreneurial focus on improving the way providers and their patients confront urologic diseases that are difficult to treat.

Every employee at Urovant plays an integral role to our success.  We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve.  Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.

Urovant’s lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB).  In addition to OAB, vibegron is being evaluated for two additional potential indications:  the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of abdominal pain associated with irritable bowel syndrome (IBS).

Urovant’s second investigational product candidate, URO-902, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.

The Associate Manager, Regulatory Advertising Promotion is responsible for supporting Urovant’s Regulatory Affairs Advertising and Promotion function and coordinating the Promotional Review Committee (PRC) process, facilitating review and approval of promotional materials for Urovant’s products.

The position is based at Urovant’s site in Irvine, CA and reports to the Executive Director, Regulatory Advertising Promotion

Responsibilities include:

  • Facilitate the PRC process, communicating established Urovant standards for creation and dissemination of reviewed materials in accordance with appropriate SOPs.
  • Develop and maintain productive working relationships with colleagues and vendors contributing to development, review, and approval of Urovant’s promotional materials, including Marketing/Commercial (and their Agencies), Legal, Compliance, Regulatory Affairs/Labeling, and Medical Affairs.
  • Ensure appropriate training of participants in the PRC process by developing and maintaining training materials, as appropriate.
  • Schedule and manage PRC meetings, working with Marketing to ensure that agendas are appropriate. Capture and document review comments during PRC meetings.
  • Route jobs for review through the designated electronic system(s) for the PRC process.
  • Document and ensure follow-up on deviations from the standard PRC process.
  • Work closely with the Legal and Compliance departments to address identified issues, as needed.
  • Engage with R&D colleagues in Project Management, Clinical, CMC, Regulatory, Quality, and Medical Affairs, as appropriate, to meet team and functional goals.
  • Provide promotional labeling and advertising review support to Regulatory Affairs Advertising and Promotion colleagues.
  • Proofread final copy to ensure all PRC process feedback has been incorporated.
  • Provide final QC review and approval of promotional material.
  • Participate in proofreading of product labeling components, package inserts, brief summaries as required, by requested deadlines.
  • Support preparation of FDA Form 2253 submissions and requests for advisory comment submissions to FDA’s Office of Prescription Drug Promotion (OPDP), as applicable.

 

Education and Experience

  • Bachelor’s degree in science or health related discipline
  • 2 plus years of Regulatory Affairs Ad Prom, Labeling, or equivalent experience.

 

Essential Skills and Abilities

  • Ability to work in a team environment
  • Working knowledge of prescription product advertising regulations
  • Strong project management skills and ability to perform/prioritize multiple tasks in a fast-paced, deadline-driven environment with limited supervision
  • High level interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner
  • Exceptional detail-oriented focus, with the ability to promptly assess documents for accuracy as well as consistency
  • Accurate and concise oral and written communication abilities
  • Able to innovate, analyze, and solve problems
  • Exceptional communication skills, both verbally and in writing
  • Proficiency with software/systems (e.g. Veeva, Microsoft Word/Excel/PowerPoint)
  • A commitment to collaborative teamwork and the maintenance of a professional culture based on trust and mutual respect

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