1,344 Medical Information jobs in the United States

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

The Multilingual Medical Information Specialist (MMIS) position is part of the ProPharma Medical Information Contact Center and follows all corresponding regulations, industry standards, and client/internal policies regarding medical information and the collection and documentation of adverse events, special situation events, and product complaints

*LOOKING FOR CANDIDATES LOCATED IN BRAZIL ONLY

Essential Functions Include:Medical Information service delivery
• Responds to unsolicited consumer, health care professional and other external customer requests for medical and safety information received via telephone, website/e-mail, letter, fax, and scientific meetings on behalf of ProPharma` s pharmaceutical clients.
• Provides labeled and unlabeled medical/safety information responses in accordance with regulatory requirements, industry standards and client and ProPharma internal policies and practices.
• Accurately identifies, documents and reports adverse events, pregnancy reports, special situation events and product complaints in a clear and concise manner per government regulations, ProPharma`s Standard Operating Procedures (SOPs) and client Working Practices (WPs).
• Translating English documents into the target language or vice versa and delivering these translated responses either on the phone or in writing.
• Ensures tasks are completed within the deadlines documented in the agreed ProPharma SOPs and WPs.
• Formulates and provides accurate responses utilizing approved labeling and company standard responses, published literature and other data. Assists with writing custom medical information responses utilizing this data.
• Logging all enquiries handled in an accurate, comprehensive, and timely fashion into Inquiry Handling Systems. Quality Assurance
• Maintains quality in all areas of the job, including performing quality checks on Adverse Events, Product Quality Complaints, correspondence, and enquiries logged into the Inquiry Handling Systems
• Quality checking translations in line with the translation SOP. General
• Provides after-hours coverage on a rotated basis subject to business requirements.
• Adheres to company and country-specific privacy policies, ensuring any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations described in ProPharma SOPs and the Confidentiality Statement within the Contract of Employment.
• Complies with the Company's health and safety policies.
• Other activities as assigned as delegated by the Manager.

Qualified candidates must have:
• Life science degree OR Nursing degree (RN/BS/BA/MS) OR Pharmacy degree.
• Mother tongue in Brazilian Portuguese.
• Fluent in English.
• Strong translation skills.
• Excellent verbal and written communication skills, including proofreading, professional telephone etiquette and empathetic customer service skills.
• Ability to write in a fluent and grammatically correct manner in the target language for the role
• English language proficiency. Japan-based roles only: TOEIC 800=<
• Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards.
• Strong cognitive abilities, including verbal reasoning, critical thinking and analytical ability.
• Ability to multitask with attention to detail within restrictive timeframes, including sound planning, prioritizing and organizational skills.
• Proactive with demonstrative ability to independently identify problems and suggest effective solutions.
• Ability to learn, take instruction and apply to daily operations/tasks.
• Receptive to constructive feedback and able to take responsibility for work allocated.
• Self-motivating. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects.
• Effectively work independently and as part of a team.
• Highly proficient in computer applications, including Microsoft Office software platforms and Adobe Acrobat, and experience using a document management system. Aptitude to learn other computer systems including inquiry handling database.

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#LI-REMOTE

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

The Director, Medical Information & Content Approval, Vaccines plays a critical role in managing a team that ensures the US and global promotional and non-promotional content meets the highest standards of quality, scientific accuracy, balance, and compliance that meets the scientific needs of customers to help inform clinical care and formulary access decisions. This includes ensuring the adherence to internal GSK standards and applicable external regulations, including an understanding of the ABPI code of practice. This role supports the Sr. MI &CA Director to develop and execute the Medical Information and Content Approval strategy, including innovative digital MI solutions. The Director serves as an influential partner to Medical Affairs, Commercial and other key business stakeholders.

Key Responsibilities:

Leadership:

• Lead and oversee the Global Medical Information and Content Approval Team for the Vaccines therapeutic area (TA), who are sought out as subject matter experts for their products within the broader medical organization.
• Contribute to the development and execution of the Global Medical Information and Content Approval strategic priorities, including digital solutions, to ensure internal/external stakeholder information needs are optimally met.
• Leading and managing team members to ensure performance objectives are met, providing mentorship and coaching team to support development and resolve challenges.
• Mentor and develop team members, ensuring they have adequate training and tools, and facilitate their professional development through differentiated development plans.
• Act as a delegate of the Senior Director, Medical Information and Content Approval at Leadership team meetings and other relevant meetings requiring TA specific leadership attendance, as required.

• Accountable for MI launch readiness plans including planning and maintaining a robust, high quality and up to date MI database incorporating medical insights to help inform clinical decision making by HCPs
• Maintain a robust understanding of, and stay up to date with changes to, the ABPI Code of Practice and other regulatory guidelines to assist team members and escalate, when appropriate.
• Ensures team members complete thorough and timely review of promotional and non-promotional US and global materials, ensuring content is scientifically accurate, meets the scientific rigor (i.e., levels of evidence); is fair-balanced and meets the compliance requirements/standards.
• Accountable for ensuring MI requirements of the payer strategy for the U.S are met.
• Partner with GMI Contact Centre (MI CC) Director/s to ensure the MI CC staff are well trained on new products or new scientific data in a timely manner.
• Work alongside various business partners and leaders (e.g., Legal, Medical, Clinical, Regulatory, Commercial) to align, validate, and identify solutions to ensure content is of the highest quality and relevant to the audience.
• Support GMI&CA team activities (e.g. MI content creation, medical review and approval), when required and in onboarding new team members.

• Strategically partner with key global TA and US medical stakeholders to maintain a good understanding of the medical strategy of high-priority assets of the TA and ensure MI meets the needs of HCPs worldwide.
• Ensure effective scientific exchange with external customers, driving excellence in MI activities at important US and Global Congresses, leveraging innovative digital solutions.
• Represent Medical Information and Content Approval on cross functional or medical leadership meetings/forums of the TA area of responsibility.
• Work alongside various business partners and leaders (e.g., Legal, Medical, Clinical, Regulatory, Commercial) to align, validate, and identify solutions to ensure content is of the highest quality and relevant to the audience.

• PharmD, MD, PhD, or equivalent.
• 6+ years of experience in the pharmaceutical industry.
• 4+ years of experience in medical writing and/or promotional review and approval.
• 4+ years of experience in customer-focused, problem-solving, and conflict resolution roles.
• Experience in people leadership, management and development
• Experience working in a highly dynamic, changing, and matrixed environment.

• Experience communicating and translating evidence and customer insights to/with matrix team partners; proven ability to develop innovative, customer-focused medical solutions and resources
• Experience of working at both global and local country level
• Experience in Vaccines
• Experience influencing internal and external stakeholders on priorities and needs to fill scientific data gaps or needs of external customers
• Strong understanding of international Codes of Practice FDA, IFPMA, EFIPIA, IPHA, ABPI, etc.
• Experience in reviewing and approving promotional and non-promotional content
• Ability to develop and maintain strong trusted relationships with internal stakeholders.
• Demonstrated customer-focus, problem-solving abilities, and strong conflict resolution skills.
• Strong clinical literature evaluation skills
• Strong communication skills

Compiles, processes, and maintains health records in a manner consistent with medical, administrative, ethical, legal, and regulatory requirements of the health care system. Prepares health records in accordance with health information management policies and procedures. Processes incoming health records for scanning and ensures the health information is up to date. Prepares deceased, inactive, and paper health records for archiving. Deactivates deceased into EHR/RPMS. Maintains health records in accordance with health information principles. Protects health records so that confidentiality is maintained. Conducts quality audits to verify the integrity and overall quality of scanned images. Prepares deceased and inactive health records for archiving by adhering to Indian Health Service disposition schedule. Processes routine requests for the release of information (ROI) that present in person, mail, fax, and/or phone while ensuring identification and authorization before release. Ensures rules and regulations of the Privacy Act of 1974, the HIPAA Privacy Rule, and HITECH are adhered to. Maintains log for release of information in accordance with the HIPAA Privacy Rule. Maintains health information exchange with the Indian Health Service, tribal/urban facilities, hospitals, and other healthcare professionals for continuity of care. Routinely monitors Updox. Weekly/daily pick up of scanning from all WRFCHC locations. Tracking scanning errors in EHR. Other duties as assigned to maintain and enhance the operation of the department.

The Area Supervisor is responsible for managing the daily scheduling of the ROI Specialists at specified client sites. The Area Supervisor will act as the liaison between MRO and Client Management staff to ensure that all ROI activities are compliant with established client policies, federal and state regulations and are completed in a timely manner.

Position requires travel throughout Vero Beach, Port. St. Lucie, and Weston, Florida.

Tasks and Responsibilities:

• Manages workflow among on-site employees at multiple client sites to ensure maximum productivity and quality standards are met.
• Adjusts work assignments as needed to cover peak periods, leave and vacancies at the staffed hospital sites.
• Provides coverage in event of backlogs, illness, vacation or leave of absence of ROI Specialists.
• Performs Quality Assurance monitoring of work performance for the ROI Specialists.
• In conjunction with and under the direction of the Area Manager, conducts productivity and work performance reviews for ROI Specialist in accordance with MRO/customer policies and procedures and Federal/State law.
• In conjunction with and under the direction of the Area Manager, monitors performance and provides performance feedback for ROI Specialists.
• Manages employee schedules and approves bi-weekly payroll to include approval of PTO requests.
• Promotes a positive self-image of MRO with emphasis on customer service by treating patients, co-workers, and medical center personnel with courtesy and respect. Responds to customer needs in a positive and efficient manner.
• Provides support to the Area Manager as needed.

Skills|Experience:

• High School Diploma/GED required.
• Bachelor's and/or Associates Degree in Health Information Management, Business Administration or health related field or equivalent experience is preferred.
• 1 years supervisory/management experience in acute care setting.
• Knowledge of HIPAA privacy information standards required.
• Demonstrates excellence in written communication and interpersonal skills.
• Proficiency in Microsoft Office Applications required.

Physical Requirements:

• Position requires standing, sitting, lifting to 20 pounds.
• Position is performed in office and hospital settings.
• Valid Driver's license and ability to travel to client sites

*This job description reflects management's assignment of essential functions. It does not prescribe or reflect the tasks that may be assigned.

Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.