Sr Manager, Global Medical Information

We need to output HTML fragment with sections: About the role? The posting includes "Why Us?" which is like about the company. Could map to "About the role" or maybe "About the company". The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to decide which sections have content. We have: - Why Us? (company description) could be "About the role" or maybe "About the company". Since they said "About the role" as example, we can use that heading for the Why Us? content. - Job Description Summary: could be part of responsibilities? Actually summary is like overview. Could be placed under "About the role" as well, but we already used that. Maybe we treat "Job Description Summary" as part of responsibilities? But we have a separate "Responsibilities" section later with essential functions. So we could put the summary under "About the role" and then responsibilities under "Responsibilities". That seems fine. - Responsibilities: The "Job Description ESSENTIAL FUNCTIONS:" list. That's responsibilities. - Requirements: Education MINIMUM REQUIREMENTS: Advanced degree... Experience: minimum of five years... So we can combine education and experience under "Requirements". Also maybe "Preferred Skills/Qualifications" could go under "Qualifications" or "Skills". The instruction: Use headings for Qualifications, Skills, Benefits, Pay, Schedule. So we have "Preferred Skills/Qualifications" maybe under "Qualifications". Then "Skills/Competencies" and "Other Skills/Competencies" could go under "Skills". Also "Organizational Relationships/Scope" maybe not needed; could be omitted as not a standard heading. "Working Conditions" maybe not needed; could be omitted unless we have a heading like "Work Environment" but not in list. So we may drop. - Benefits, Pay, Schedule: Not present, so omit. Thus sections: About the role (Why Us? + Job Description Summary), Responsibilities (Essential Functions), Requirements (Education + Experience), Qualifications (Preferred Skills/Qualifications), Skills (Skills/Competencies + Other Skills/Competencies). Possibly also include "Organizational Relationships/Scope" as a section? Not in allowed headings; we could omit. We must preserve all substantive information, not invent or summarize away detail. Must not include boilerplate like EEO, Disclaimer, etc. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we need to strip the Disclaimer and EEO Statement. Also remove duplicated lines: there may be duplicates? Not obvious. We need to output only HTML fragment, no /, no markdown fences. Let's extract content. Why Us? paragraph: "Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day." Job Description Summary: "The Global Medical Information Lead provides oversight and management of all activities pertaining to medical information inquiries for products marketed by Par Health (The Company) to ensure safe product usage and a regulatory compliant work environment. Responsible for providing technical and clinical information regarding product usage and performance. Clinically educate other members of the post-market surveillance team, call center and medical information vendor personnel, and other personnel within The Company as needed. Provide support and review of The Company’s medical and promotional material. Serve as the Business owner for the call center and medical information vendor/CRO to ensure compliant medical information globally." We can combine these under About the role. Responsibilities: list of essential functions. Need to convert each bullet into

. The text after "ESSENTIAL FUNCTIONS:" includes many sentences separated by semicolons or line breaks. We need to parse into list items. Let's list them: - Leadership of the medical information team - Responsible for the compliance and trending of medical information inquiries with company procedures - Composes and maintains standardized response letters (SRLs); serves as the business owner for SRLs - Performs continual independent review of medical/scientific literature on The Company’s products and competitor's pharmaceutical products - Critically evaluates medical/scientific literature and determine appropriate usage - Provide support for medical review of The Company’s medical and promotional materials - Participates on cross-functional teams concerned with development or support of products as needed - Provides professional consultation in matters related to safety, efficacy, and proper product usage as needed - Provides support for Pharmacovigilance and Product Monitoring (i.e. Health Hazard Evaluations, customer letters) as needed - Serves as a member of the Signal Action Committee which performs medical and scientific review of safety signals that have been identified by the Pharmacovigilance department. - Complies with all relevant related guidelines, standards and regulations pertaining to medical information provided to customers globally - Maintains Standard Operating Procedures (SOP’s) for responding to unsolicited requests for medical information globally - Collaboratively and effectively communicates with various departments, including Legal, Regulatory Affairs, R&D, Engineering, Business Development Leadership, Commercial, Pharmacovigilance, and Customer Service. - Provide guidance to the call center and medical information vendor/CRO regarding the provision of medical information for The Company’s products globally, including ensuring the vendor has the most recent product labeling for each country. - Monitor the vendor/CRO’s performance and adherence to company policies and procedures. - Performs internal quality assessments and medical review of information provided by The Company’s personnel. - Acts as the subject matter expert for medical information during audits and regulatory inspections. - Participate in the drafting of audit and inspection responses and assist in the coordination and completion of corrective actions related to audits and inspections. - Prepare and deliver accurate medical information and other post-market reports on regular and ad-hoc basis and identify potential performance issues and alert appropriate management personnel when needed. - Identify, hire, train, develop and manage medical information specialists. We need to ensure each is a separate

. Some items have multiple clauses separated by semicolons but we keep as one item. Now Requirements: Education MINIMUM REQUIREMENTS: Advanced degree in relevant medical specialty required (i.e. PharmD, RPh, Physician’s Assistant (PA), etc.) Experience: A minimum of five years of clinical/practical experience in a relevant clinical environment or related Post-Market Surveillance experience in the pharmaceutical and/or medical device industry. We can combine into a

with two items. Qualifications: Preferred Skills/Qualifications: Healthcare certification; Previous Medical Affairs, Regulatory Affairs, and or Medical Communications experience in the pharmaceutical industry; Experience interacting with regulatory agencies such as the FDA.; Writing skills necessary to effectively communicate technical/clinical information to others. We can list each as
• . Skills: Skills/Competencies: Flexible leader; Highly self-motivated; Strong Communication and Presentation skills; Problem Solving and Scientific evaluation skills. Other Skills/Competencies: Sound organizational skills with the ability to prioritize tasks; Ability to build productive relationships with personnel within and outside of the department and company; Demonstrated ability to manage complex processes and cross-functional teams. We can combine both lists under Skills heading. We should not include Organizational Relationships/Scope or Working Conditions. Now ensure we don't include any boilerplate like Disclaimer, EEO Statement. Now produce HTML:

  About the role

  Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

  The Global Medical Information Lead provides oversight and management of all activities pertaining to medical information inquiries for products marketed by Par Health (The Company) to ensure safe product usage and a regulatory compliant work environment. Responsible for providing technical and clinical information regarding product usage and performance. Clinically educate other members of the post-market surveillance team, call center and medical information vendor personnel, and other personnel within The Company as needed. Provide support and review of The Company’s medical and promotional material. Serve as the Business owner for the call center and medical information vendor/CRO to ensure compliant medical information globally.

  Then Responsibilities:

  Responsibilities

  • Leadership of the medical information team
  • Responsible for the compliance and trending of medical information inquiries with company procedures
  • Composes and maintains standardized response letters (SRLs); serves as the business owner for SRLs
  • Performs continual independent review of medical/scientific literature on The Company’s products and competitor's pharmaceutical products
  • Critically evaluates medical/scientific literature and determine appropriate usage
  • Provide support for medical review of The Company’s medical and promotional materials
  • Participates on cross-functional teams concerned with development or support of products as needed
  • Provides professional consultation in matters related to safety, efficacy, and proper product usage as needed
  • Provides support for Pharmacovigilance and Product Monitoring (i.e. Health Hazard Evaluations, customer letters) as needed
  • Serves as a member of the Signal Action Committee which performs medical and scientific review of safety signals that have been identified by the Pharmacovigilance department.
  • Complies with all relevant related guidelines, standards and regulations pertaining to medical information provided to customers globally
  • Maintains Standard Operating Procedures (SOP’s) for responding to unsolicited requests for medical information globally
  • Collaboratively and effectively communicates with various departments, including Legal, Regulatory Affairs, R&D, Engineering, Business Development Leadership, Commercial, Pharmacovigilance, and Customer Service.
  • Provide guidance to the call center and medical information vendor/CRO regarding the provision of medical information for The Company’s products globally, including ensuring the vendor has the most recent product labeling for each country.
  • Monitor the vendor/CRO’s performance and adherence to company policies and procedures.
  • Performs internal quality assessments and medical review of information provided by The Company’s personnel.
  • Acts as the subject matter expert for medical information during audits and regulatory inspections.
  • Participate in the drafting of audit and inspection responses and assist in the coordination and completion of corrective actions related to audits and inspections.
  • Prepare and deliver accurate medical information and other post-market reports on regular and ad-hoc basis and identify potential performance issues and alert appropriate management personnel when needed.
  • Identify, hire, train, develop and manage medical information specialists.
  Requirements:

  Requirements

  • Advanced degree in relevant medical specialty required (i.e. PharmD, RPh, Physician’s Assistant (PA), etc.)
  • A minimum of five years of clinical/practical experience in a relevant clinical environment or related Post-Market Surveillance experience in the pharmaceutical and/or medical device industry.
  Qualifications:

  Qualifications

  • Healthcare certification
  • Previous Medical Affairs, Regulatory Affairs, and or Medical Communications experience in the pharmaceutical industry
  • Experience interacting with regulatory agencies such as the FDA.
  • Writing skills necessary to effectively communicate technical/clinical information to others.
  Skills:

  Skills

  • Flexible leader
  • Highly self-motivated
  • Strong Communication and Presentation skills
  • Problem Solving and Scientific evaluation skills