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Key Responsibilities and Required Skills for Medical Information Communication Specialist

💰 $70,000 - $120,000

Medical AffairsPharmaceuticalHealthcare CommunicationsRegulatory

🎯 Role Definition

The Medical Information Communication Specialist is a subject-matter expert responsible for receiving, triaging, researching, and delivering scientifically accurate, compliant medical and scientific responses to healthcare professionals, patients, and internal stakeholders. This role ensures that medical information is evidence-based, aligned with applicable regulations (e.g., FDA, EMA), and consistent with company policy and SOPs, while partnering closely with pharmacovigilance, regulatory, clinical, commercial, and medical affairs teams. Ideal candidates combine therapeutic-area knowledge, medical writing and literature-search skills, and a customer-focused communication style.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Clinical Pharmacist or Registered Nurse transitioning to industry medical information
  • Medical Writer / Scientific Communicator with healthcare background
  • Pharmacovigilance or Drug Safety Associate with exposure to medical inquiries

Advancement To:

  • Senior Medical Information Specialist / Lead
  • Medical Information Manager / Medical Communications Manager
  • Medical Affairs or Scientific Communications Director
  • Medical Science Liaison (MSL) or Therapeutic Area Lead

Lateral Moves:

  • Medical Writing (publications, regulatory writing)
  • Pharmacovigilance / Drug Safety
  • Regulatory Affairs
  • Clinical Operations or Field Medical roles

Core Responsibilities

Primary Functions

  • Receive, triage, and manage inbound medical information inquiries from healthcare professionals, patients, payers, and internal colleagues via phone, email, web portals, and CRM systems; ensure timely acknowledgement and escalation according to SLA and SOPs.
  • Conduct comprehensive, evidence-based literature searches (PubMed, Embase, Cochrane, clinicaltrials.gov) to identify, appraise, and synthesize peer-reviewed data to support written medical responses and scientific exchanges.
  • Draft, review, and finalize medically and scientifically accurate response letters, FAQs, standard response documents (SRDs), and customized medical information materials that align with approved labeling and internal policies.
  • Ensure all medical information responses are in compliance with company SOPs, global and regional regulations (e.g., FDA, EMA), promotional vs non-promotional guidance, and applicable industry codes of conduct.
  • Collaborate with pharmacovigilance/drug safety teams to identify, document, and report adverse events and product quality complaints discovered during medical inquiry handling, ensuring timely reporting and accurate case records.
  • Maintain and update the medical information knowledgebase and core response library by incorporating new scientific evidence, label changes, and cross-functional input to ensure consistency and accuracy across responses.
  • Provide medical review and scientific input for internal and external materials, including field medical slide decks, patient education content, SOPs, and promotional materials to ensure medical accuracy and regulatory compliance.
  • Provide expert medical guidance and point-of-contact support for cross-functional teams (regulatory, clinical, commercial, market access), helping translate scientific data into clear, compliant messaging for external stakeholders.
  • Prepare and deliver professional scientific responses for complex requests such as off-label use questions, mechanistic inquiries, pharmacology/pharmacokinetics, dosing and administration, contraindications and drug interactions.
  • Coordinate complex inquiries that require multi-stakeholder input (clinical development, safety, regulatory) and manage the internal review and approval workflow to deliver timely and accurate responses.
  • Provide triage and escalation management for high-priority inquiries such as product shortages, medication errors, safety signals, or requests from key opinion leaders (KOLs), ensuring rapid coordination across functional teams.
  • Participate in periodic medical information audits and quality assurance reviews; identify root causes for deviations and drive corrective and preventive actions (CAPAs) to improve response quality and compliance.
  • Develop and deliver medical information training and coaching for customer-facing teams (sales, field medical, patient support) to enhance scientific knowledge, appropriate escalation, and compliant communication.
  • Monitor scientific literature, conference proceedings, and health authority updates to proactively identify evidence that could impact product information and update internal stakeholders and the MI knowledgebase.
  • Support publication planning and scientific communications by drafting, formatting, and reviewing abstracts, posters, and manuscript content or by providing medical input and literature references.
  • Generate metrics and operational reports (e.g., inquiry volumes, response turnaround times, topic trends) to identify patterns, inform resource planning, and drive continuous improvement initiatives for the MI function.
  • Manage vendor relationships and external service providers (e.g., literature search vendors, medical writing contractors) when outsourced support is required, ensuring quality, timelines, and contractual compliance.
  • Serve as a subject-matter expert for patient-facing materials and compassionate use inquiries, ensuring language, readability, and medical accuracy while respecting regulatory and ethical boundaries.
  • Lead or participate in cross-functional projects such as SOP development, implementation of new MI systems (e.g., Veeva, Arxspan, Salesforce Health Cloud), or process automation to enhance efficiency and traceability.
  • Maintain accurate documentation in medical information databases and CRM systems, ensuring audit-ready records, traceability of author/reviewer interactions, and adherence to data privacy and confidentiality requirements (e.g., HIPAA, GDPR considerations).
  • Support remote or global operations by aligning regional medical information procedures with local regulatory requirements and liaising with global medical information teams to ensure consistency of scientific communications.

Secondary Functions

  • Develop and maintain standardized templates, response frameworks, and evidence tables that accelerate consistent and high-quality response delivery.
  • Support ad-hoc medical and scientific data requests from internal stakeholders, including custom literature reviews, slide decks, and evidence summaries for meetings or pitches.
  • Participate in cross-functional working groups (safety signal evaluation, promotional review committees, labeling updates) to contribute medical expertise and ensure consistent external messaging.
  • Provide input into medical information strategy and roadmap, identifying opportunities for knowledgebase optimization, automation, and AI-assisted literature screening.
  • Assist with content migration and validation during implementation of new medical information systems and digital platforms, ensuring content integrity and user acceptance testing.
  • Help maintain KPIs and SLA dashboards, propose process improvements, and lead small projects to reduce turnaround time and increase first-time-right response rates.
  • Contribute to the development of patient education tools and FAQs that improve patient adherence and understanding while remaining non-promotional and evidence-based.
  • Support field-based colleagues with pre-approved medical literature and responses for common inquiries while ensuring appropriate escalation for complex questions.
  • Coordinate with legal and regulatory teams during product lifecycle events to ensure MI content reflects current label changes, brand strategy, and health authority communications.
  • Provide back-up support for on-call medical information coverage, including crisis or emergent medical communications during product issues or public health events.

Required Skills & Competencies

Hard Skills (Technical)

  • Advanced scientific literature searching and critical appraisal (PubMed/MEDLINE, Embase, Cochrane, clinicaltrials.gov).
  • Medical writing and editing for medically accurate, audience-tailored responses (HCP-facing and patient-facing).
  • Familiarity with medical information systems and CRM platforms (e.g., Veeva, Arxspan, Salesforce Health Cloud, Zendesk).
  • Strong working knowledge of pharmacovigilance fundamentals: adverse event identification, case documentation, and reporting timelines.
  • Regulatory awareness of global marketing and safety requirements (FDA, EMA, ICH guidelines) and promotional vs. non-promotional boundaries.
  • Experience maintaining and curating knowledgebases and standard response documents (SRDs).
  • Proficiency with bibliographic and reference management tools (EndNote, Mendeley) and citation formatting.
  • Competency in Microsoft Office suite (Word, Excel, PowerPoint) for evidence summaries, data reporting, and slide preparation.
  • Ability to interpret clinical study data, statistical outcomes, and product labeling to craft accurate replies.
  • Experience with quality systems: SOP adherence, CAPA implementation, and documentation for audit readiness.
  • Familiarity with content management systems (CMS) and digital publishing guidelines for patient education materials.
  • Experience generating KPIs and operational metrics and using them to drive process improvements.

Soft Skills

  • Excellent verbal and written communication skills with the ability to distill complex scientific concepts into clear, audience-appropriate language.
  • Strong customer service orientation and professional demeanor in responding to HCPs, patients, and internal stakeholders.
  • High attention to detail and accuracy in documentation and scientific interpretation.
  • Critical thinking and problem-solving to triage complex inquiries and identify appropriate escalation paths.
  • Collaborative team player comfortable working cross-functionally with safety, regulatory, clinical, commercial, and legal teams.
  • Time management and prioritization skills to meet SLA-driven response timelines and handle fluctuating inquiry volumes.
  • Adaptability in a regulated, fast-paced environment with evolving evidence and labeling.
  • Integrity and sound judgment when dealing with off-label questions, safety signals, and confidential information.
  • Project management basics: ability to manage multiple tasks, track deliverables, and engage stakeholders to closure.
  • Coaching and mentoring ability to support junior team members and transfer technical knowledge.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in life sciences, nursing, pharmacy, biomedical sciences, or related scientific discipline (BSc, BSN, PharmD preferred).

Preferred Education:

  • Advanced degree (PharmD, MD, PhD, MSN, or MSc) or equivalent clinical experience is strongly preferred.
  • Certification or coursework in medical writing, pharmacovigilance, or regulatory affairs is advantageous.

Relevant Fields of Study:

  • Pharmacy
  • Medicine / Nursing
  • Biomedical Sciences
  • Pharmacology / Clinical Research
  • Public Health / Health Communications

Experience Requirements

Typical Experience Range: 2–5 years in medical information, medical writing, pharmacovigilance, clinical research, or a related pharmaceutical/biotech role.

Preferred: 3–7+ years of direct medical information experience within pharmaceutical, biotechnology, or medical device organizations, with demonstrated experience handling complex HCP inquiries, pharmacovigilance coordination, and knowledgebase management.

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