KalVista Pharmaceuticals, Inc.
Sr. Mgr., Medical Information & Communications
KalVista Pharmaceuticals, Inc., Cambridge, Massachusetts, us, 02140
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a global pharmaceutical company whose mission is to develop and deliver life-changing, oral medicines for people affected by rare diseases with significant unmet need. Sebetralstat, our novel, investigational candidate for the oral, on-demand treatment of hereditary angioedema, is under regulatory review by the U.S. FDA with a PDUFA goal date of June 17, 2025. In addition, we have completed marketing authorization application (MAA) submissions for sebetralstat to the European Medicines Agency as well as the United Kingdom, Switzerland, Australia and Singapore, and we anticipate filing a MAA in Japan in late 2024.
For more information about KalVista, please visit
www.kalvista.com
or follow on social media at
@KalVista
and
LinkedIn .
About the role:
As a Senior Manager, Medical Information and Communications you will be responsible for developing, reviewing, and updating local medical information content. This role will oversee the day-to-day implementation of the global Medical Information strategy, ensuring the delivery of evidence-based information to both internal and external stakeholders. This role will also support medical communication activities.
Responsibilities:Assist with the creation of a comprehensive medical information strategy for and lead implementation effortsDevelop and lead all functional aspects of the Medical Information roleCreate, review, and update standard response documents and FAQsDevelop and maintain a comprehensive knowledge database to house SRDs, FAQs, and other essential communications and informational documentsRespond to medical information inquiries in a timely manner, escalating issues where appropriate and ensuring cross-functional communication with key internal stakeholders as necessaryDevelop and manage a contact center, monitoring closely for quality and effectivenessAct as the medical reviewer for all promotional and non-promotional materialsOversee quality control to ensure all medical information activities comply with regulatory requirements, industry standards, and company policies.Conduct regular audits and quality checksAs needed, participate in the execution of medical communication deliverablesCompletes all assigned SOPs and training within designated timeframe and adheres to job-specific SOPs and work instructionsSupport medical and scientific discussions, presentations, data exchange, and internal training and education through ongoing dialogue with and support to the field-based teamsAggregate, analyze, and derive scientifically significant conclusions from shared data and issue reports to relevant stakeholdersStay up to date on scientific publications and congress activities in the therapy area and circulate relevant papers to stakeholdersRepresent
KalVista Pharmaceuticals
and own the information both for congresses, conferences, and other eventsVendor and contractor management including performance, quality, and budget oversightActs as a subject matter expert for one or more therapeutic areas (TAs)Proactively develops and updates local medical information content that is current, complete, medically accurate, and fair- balancedQualifications:
5+ years of experience in Medical Information services for the pharmaceutical industry.Launch experience preferredThorough understanding of the medical/promotional review processDemonstrated experience providing medical review of MLR materialsExperience using and implementing medical information databases and supporting softwareExperience developing and distributing scientific materials pertaining to pharmaceuticalsProficient in medical writing for medical information response documentsAbility to summarize medical literature/ accurately and appropriately (creating medical information response documents that are accurate, current, scientifically fair- balanced, and of high quality)Outstanding communication skills to relay complex information in a comprehensive way to both internal and external audiencesTravel up to 10%
KalVista is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
Important Notice to Third-Party Recruiters & Staffing Agencies:
The current job openings advertised on this website are for the sole purpose of candidates to apply directly. Unsolicited and anonymous CVs submitted in any manner to KalVista employees, including to employee personal e-mail accounts, are considered to be the property of KalVista and will not qualify for a fee to be paid. Referral fees will only be payable where KalVista has agreed with an agency to work on a specific appointment, and then only in conjunction with a fully-executed contract for service.
If any Agency representative contacts a KalVista Hiring Manager or company employee, other than a member of the KalVista Talent Acquisition team, to solicit an appointment to engage on a job opening, that Agency will not be considered for that specific job opening or future opportunities with KalVista.
Thank you for your understanding and cooperation.
KalVista Pharmaceuticals, Inc. is a global pharmaceutical company whose mission is to develop and deliver life-changing, oral medicines for people affected by rare diseases with significant unmet need. Sebetralstat, our novel, investigational candidate for the oral, on-demand treatment of hereditary angioedema, is under regulatory review by the U.S. FDA with a PDUFA goal date of June 17, 2025. In addition, we have completed marketing authorization application (MAA) submissions for sebetralstat to the European Medicines Agency as well as the United Kingdom, Switzerland, Australia and Singapore, and we anticipate filing a MAA in Japan in late 2024.
For more information about KalVista, please visit
www.kalvista.com
or follow on social media at
@KalVista
and
LinkedIn .
About the role:
As a Senior Manager, Medical Information and Communications you will be responsible for developing, reviewing, and updating local medical information content. This role will oversee the day-to-day implementation of the global Medical Information strategy, ensuring the delivery of evidence-based information to both internal and external stakeholders. This role will also support medical communication activities.
Responsibilities:Assist with the creation of a comprehensive medical information strategy for and lead implementation effortsDevelop and lead all functional aspects of the Medical Information roleCreate, review, and update standard response documents and FAQsDevelop and maintain a comprehensive knowledge database to house SRDs, FAQs, and other essential communications and informational documentsRespond to medical information inquiries in a timely manner, escalating issues where appropriate and ensuring cross-functional communication with key internal stakeholders as necessaryDevelop and manage a contact center, monitoring closely for quality and effectivenessAct as the medical reviewer for all promotional and non-promotional materialsOversee quality control to ensure all medical information activities comply with regulatory requirements, industry standards, and company policies.Conduct regular audits and quality checksAs needed, participate in the execution of medical communication deliverablesCompletes all assigned SOPs and training within designated timeframe and adheres to job-specific SOPs and work instructionsSupport medical and scientific discussions, presentations, data exchange, and internal training and education through ongoing dialogue with and support to the field-based teamsAggregate, analyze, and derive scientifically significant conclusions from shared data and issue reports to relevant stakeholdersStay up to date on scientific publications and congress activities in the therapy area and circulate relevant papers to stakeholdersRepresent
KalVista Pharmaceuticals
and own the information both for congresses, conferences, and other eventsVendor and contractor management including performance, quality, and budget oversightActs as a subject matter expert for one or more therapeutic areas (TAs)Proactively develops and updates local medical information content that is current, complete, medically accurate, and fair- balancedQualifications:
5+ years of experience in Medical Information services for the pharmaceutical industry.Launch experience preferredThorough understanding of the medical/promotional review processDemonstrated experience providing medical review of MLR materialsExperience using and implementing medical information databases and supporting softwareExperience developing and distributing scientific materials pertaining to pharmaceuticalsProficient in medical writing for medical information response documentsAbility to summarize medical literature/ accurately and appropriately (creating medical information response documents that are accurate, current, scientifically fair- balanced, and of high quality)Outstanding communication skills to relay complex information in a comprehensive way to both internal and external audiencesTravel up to 10%
KalVista is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
Important Notice to Third-Party Recruiters & Staffing Agencies:
The current job openings advertised on this website are for the sole purpose of candidates to apply directly. Unsolicited and anonymous CVs submitted in any manner to KalVista employees, including to employee personal e-mail accounts, are considered to be the property of KalVista and will not qualify for a fee to be paid. Referral fees will only be payable where KalVista has agreed with an agency to work on a specific appointment, and then only in conjunction with a fully-executed contract for service.
If any Agency representative contacts a KalVista Hiring Manager or company employee, other than a member of the KalVista Talent Acquisition team, to solicit an appointment to engage on a job opening, that Agency will not be considered for that specific job opening or future opportunities with KalVista.
Thank you for your understanding and cooperation.