Executive Director - Medical Information
To see similar active jobs please follow this link: Remote Management jobs
Title: Executive Director, Medical Information
Location: Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered as a subcutaneous injection once weekly that blocks both B -cell activating factor (BAFF) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce galactose deficient IgA1 (Gd-IgA1) and associated auto-antibodies which together form immune complexes which are fundamental in the pathogenesis of IgA nephropathy (IgAN). In addition, Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information please visit: www.veratx.com.
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Position Summary:
The Executive Director, Medical Information will report to the SVP, Medical Affairs and will be responsible for creating and communicating medical information compliant with industry best practices and applicable regulatory guidelines. As a key member of the Medical Affairs team the Executive Director, Medical Information will serve as a key medical resource within Vera Therapeutics. The Executive Director, Medical Information creates and communicates balanced medical information compliant with industry best practices and applicable regulatory guidelines in the US. As a member of the Medical Affairs team, the Executive Director maintains a high level of scientific knowledge and collaborates with numerous internal and external stakeholders.
Responsibilities:
Interpret and utilize scientific data to create written medical information documents (e.g. standard response letters, custom response letters, AMCP dossiers) used in response to unsolicited inquiries from healthcare professionals and consumers.
Develop and maintain a database of standard response letters (SRLs) to ensure dissemination of medical information is timely, balanced, and scientifically accurate.
Manage internal review process for SRLs, CRLs and FAQs.
Oversee and manage inbound medical information inquiries, medical writing, and other day-to-day activities.
Contribute to or lead the creation and review of medical communications content, including disease- and product-related slide decks, digital/web-based medical content, and Medical Science Liaison resources for scientific exchange.
Perform scientific/medical review of promotional materials for assigned product(s)/therapeutic area(s).
Monitor emerging relevant scientific publications through biomedical literature database searches.
Monitor medical information inquiries for trends and insights and report to relevant internal stakeholders.
Become and remain well-versed in the understanding of assigned therapeutic area, including product knowledge, disease state management, new therapies, and competitive landscape.
Support product launch and lifecycle activities, including attendance at Medical Congress Medical Information booths.
Lead the compendia submission process for Medical Affairs.
Collaborate with Medical Directors and other members of the Medical Affairs team regarding Medical Information response documents and other Medical Affairs initiatives as needed.
Conduct product and adverse event training for sales representatives and commercial partners.
Qualifications:
Bachelor’s degree required; Advanced scientific degree (MS, PharmD, MD, or PhD) strongly preferred.
10+ years of experience in pharmaceutical/biotechnology Medical Information is required.
Ability to read, understand and translate clinical study reports and interpret scientific data.
Medical information product preferred lead experience.
Experience creating and reviewing scientific content.
Experience leading cross-functional teams or projects is preferred.
Excellent written and oral communication skills.
Demonstrated expertise in drug information communication.
Knowledge of regulatory requirements and guidance for responding to unsolicited requests for information.
Vera Therapeutics Inc. is an equal-opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range begins at $252,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.
At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.
Fraud Alert
To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.
Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.
About the job
Executive Director - Medical Information
To see similar active jobs please follow this link: Remote Management jobs
Title: Executive Director, Medical Information
Location: Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered as a subcutaneous injection once weekly that blocks both B -cell activating factor (BAFF) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce galactose deficient IgA1 (Gd-IgA1) and associated auto-antibodies which together form immune complexes which are fundamental in the pathogenesis of IgA nephropathy (IgAN). In addition, Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information please visit: www.veratx.com.
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Position Summary:
The Executive Director, Medical Information will report to the SVP, Medical Affairs and will be responsible for creating and communicating medical information compliant with industry best practices and applicable regulatory guidelines. As a key member of the Medical Affairs team the Executive Director, Medical Information will serve as a key medical resource within Vera Therapeutics. The Executive Director, Medical Information creates and communicates balanced medical information compliant with industry best practices and applicable regulatory guidelines in the US. As a member of the Medical Affairs team, the Executive Director maintains a high level of scientific knowledge and collaborates with numerous internal and external stakeholders.
Responsibilities:
Interpret and utilize scientific data to create written medical information documents (e.g. standard response letters, custom response letters, AMCP dossiers) used in response to unsolicited inquiries from healthcare professionals and consumers.
Develop and maintain a database of standard response letters (SRLs) to ensure dissemination of medical information is timely, balanced, and scientifically accurate.
Manage internal review process for SRLs, CRLs and FAQs.
Oversee and manage inbound medical information inquiries, medical writing, and other day-to-day activities.
Contribute to or lead the creation and review of medical communications content, including disease- and product-related slide decks, digital/web-based medical content, and Medical Science Liaison resources for scientific exchange.
Perform scientific/medical review of promotional materials for assigned product(s)/therapeutic area(s).
Monitor emerging relevant scientific publications through biomedical literature database searches.
Monitor medical information inquiries for trends and insights and report to relevant internal stakeholders.
Become and remain well-versed in the understanding of assigned therapeutic area, including product knowledge, disease state management, new therapies, and competitive landscape.
Support product launch and lifecycle activities, including attendance at Medical Congress Medical Information booths.
Lead the compendia submission process for Medical Affairs.
Collaborate with Medical Directors and other members of the Medical Affairs team regarding Medical Information response documents and other Medical Affairs initiatives as needed.
Conduct product and adverse event training for sales representatives and commercial partners.
Qualifications:
Bachelor’s degree required; Advanced scientific degree (MS, PharmD, MD, or PhD) strongly preferred.
10+ years of experience in pharmaceutical/biotechnology Medical Information is required.
Ability to read, understand and translate clinical study reports and interpret scientific data.
Medical information product preferred lead experience.
Experience creating and reviewing scientific content.
Experience leading cross-functional teams or projects is preferred.
Excellent written and oral communication skills.
Demonstrated expertise in drug information communication.
Knowledge of regulatory requirements and guidance for responding to unsolicited requests for information.
Vera Therapeutics Inc. is an equal-opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range begins at $252,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.
At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.
Fraud Alert
To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.
Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.