Medical Review Manager
Xeris Pharmaceuticals, Inc.
6 months ago
Remote friendly (Chicago, IL)
United States
Medical Affairs
Responsibilities:
- Serve as an active contributor to the Medical Review Process (MedRP) for medical materials and the Material Approval Process (MAP) for promotional materials.
- Independently review and approve medical and scientific information using advanced clinical expertise (e.g., Medical Information Standard/Custom Response Letters, Clinical Dossiers, FAQs, and other requested documents).
- Lead medical review for all product promotional activities to ensure accuracy, balance, and compliance with FDA guidance/regulations, internal policies, and medical review standards; collaborate with Regulatory Affairs, Legal, Compliance, Marketing, and Training.
- Provide signature authority approval for cross-functional promotional review activities, including strategic scientific consultations on brand messages, reviewing promotional materials for content/accuracy, and coordinating review/approval of clinical data on file to support promotional claims.
- Maintain expert knowledge of products, disease states, treatment guidelines, scientific literature, and competitive landscape; provide subject matter expertise to support clinical and business decisions.
- Critically evaluate scientific literature and interpret data to support promotional messages; identify potential risks and propose mitigation strategies; communicate decisions and rationale.
- Compile highlights and metrics for quarterly outcomes reports to Senior Leadership.
- Coach and mentor interns/other team members as identified.
- Develop and deliver training materials for departmental colleagues and others as identified.
- Perform medical review of other materials as required.
- Proactively identify and develop initiatives to improve and streamline Medical Affairs processes for internal/external customers.
Qualifications:
- Doctoral degree in a health sciences-related field (e.g., PharmD, MD, or PhD) with thorough grasp of the pharmaceutical industry.
- 2–3 years of healthcare/related experience after the doctoral degree, including a minimum of 2 years of medical communications experience within the pharmaceutical industry.
- Advanced oral and written communication skills; ability to build trust and respect.
- Ability to communicate effectively using highly technical/scientific language with cross-functional stakeholders.
- Strong understanding of the drug development process (pre- and post-marketing research phases/processes/techniques).
- Proven teamwork, leadership, timely decision-making, and results orientation.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Working conditions (required):
- Periodic evening/weekend work as needed.
- Overnight travel up to 20%.
- Hybrid role based in Chicago office; minimum 3 days/week in office (on-site requirement may change).
Compensation/benefits (if explicitly stated):
- Anticipated base salary range: $120,000–$175,000; eligibility for bonus and equity; additional benefits (paid time off, health insurance, retirement) described at conditional offer.
Application instructions:
- Candidates may inquire about the compensation and benefits package during the interview process.
- Serve as an active contributor to the Medical Review Process (MedRP) for medical materials and the Material Approval Process (MAP) for promotional materials.
- Independently review and approve medical and scientific information using advanced clinical expertise (e.g., Medical Information Standard/Custom Response Letters, Clinical Dossiers, FAQs, and other requested documents).
- Lead medical review for all product promotional activities to ensure accuracy, balance, and compliance with FDA guidance/regulations, internal policies, and medical review standards; collaborate with Regulatory Affairs, Legal, Compliance, Marketing, and Training.
- Provide signature authority approval for cross-functional promotional review activities, including strategic scientific consultations on brand messages, reviewing promotional materials for content/accuracy, and coordinating review/approval of clinical data on file to support promotional claims.
- Maintain expert knowledge of products, disease states, treatment guidelines, scientific literature, and competitive landscape; provide subject matter expertise to support clinical and business decisions.
- Critically evaluate scientific literature and interpret data to support promotional messages; identify potential risks and propose mitigation strategies; communicate decisions and rationale.
- Compile highlights and metrics for quarterly outcomes reports to Senior Leadership.
- Coach and mentor interns/other team members as identified.
- Develop and deliver training materials for departmental colleagues and others as identified.
- Perform medical review of other materials as required.
- Proactively identify and develop initiatives to improve and streamline Medical Affairs processes for internal/external customers.
Qualifications:
- Doctoral degree in a health sciences-related field (e.g., PharmD, MD, or PhD) with thorough grasp of the pharmaceutical industry.
- 2–3 years of healthcare/related experience after the doctoral degree, including a minimum of 2 years of medical communications experience within the pharmaceutical industry.
- Advanced oral and written communication skills; ability to build trust and respect.
- Ability to communicate effectively using highly technical/scientific language with cross-functional stakeholders.
- Strong understanding of the drug development process (pre- and post-marketing research phases/processes/techniques).
- Proven teamwork, leadership, timely decision-making, and results orientation.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Working conditions (required):
- Periodic evening/weekend work as needed.
- Overnight travel up to 20%.
- Hybrid role based in Chicago office; minimum 3 days/week in office (on-site requirement may change).
Compensation/benefits (if explicitly stated):
- Anticipated base salary range: $120,000–$175,000; eligibility for bonus and equity; additional benefits (paid time off, health insurance, retirement) described at conditional offer.
Application instructions:
- Candidates may inquire about the compensation and benefits package during the interview process.