Pharmaceutical Medical Writer

Medical Information Specialist RoleJob DescriptionThe Medical Information Specialist position is part of a global team that handles medical information inquiries and follows all corresponding regulations, industry standards, and internal policies regarding medical information and the collection and documentation of adverse events, special situation events, and product complaints.Key Responsibilities Include: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 pharmaceutical clients.Provides labeled and unlabeled medical/safety information responses in accordance with regulatory requirements, industry standards, and client and internal policies and practices.Acknowledges and accurately documents and reports adverse events, pregnancy reports, special situation events, and product complaints in a clear and concise manner per government regulations, Standard Operating Procedures (SOPs), and Working Practices (WPs).
Ensures tasks are completed within the deadlines documented in the agreed 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.Logs all enquiries handled in an accurate, comprehensive, and timely fashion into Inquiry Handling Systems.
Quality AssuranceMaintains 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 GeneralProvides 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 pharmaceutical companies and their clients is managed in accordance with Data Privacy regulations described in SOPs and the Confidentiality Statement within the Contract of Employment.Complies with the Company's health and safety policies.Other activities as assigned by the Manager.Required Skills and QualificationsEssential Qualifications Include:Nursing degree (RN/BS/BA/MS) mandatory.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.Mother tongue in Brazilian Portuguese, fluent in English.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.