Medical Affairs Job Description
Medical affairs
provides clinical safety and risk management input to clinical study protocols, clinical study reports, investigator brochure, and submission documents.
Medical Affairs Duties & Responsibilities
To write an effective medical affairs job description, begin by listing detailed duties, responsibilities and expectations. We have included medical affairs job description templates that you can modify and use.
Sample responsibilities for this position include:
Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities
Work with the GMTL and Global Medical Team (GMT) to develop medical prelaunch and early access strategy, including publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area, aligned with overall product strategy
Provide expertise in the phase3b/4 development programs and lifecycle management activities for Horizon compounds within therapeutic area business development opportunities
Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, ), where requested - with the focus on key external experts
Encourage re-use and best-practice sharing of Medical Affairs activities and deliverables
Facilitating the manager to make on mid- and long-term medical strategies and, after aligning with BA, implementing them on yearly basis
Working with line manager and BA to identify medical and scientific knowledge gaps and providing corresonding disease area medical messages, reviewing and ensuring corresponding disease area medical contents are accurate, fair, balance, evidence-based and compliance with local regulations
Supporting medical events (congress ) and ensuring all activities align with compliance and Dia Symphony requirements
Communicating with BA on issues related to publication in corresponding disease areas
Assist the Director and Medical Advisor in tracking budgets, YTD reports, preparing accruals as required
Medical Affairs Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Medical Affairs
List any licenses or certifications required by the position: MD, FEMA, PMP, ABPI, RAC, CMPP, MV, DMOS, M.D, FPX
Education for Medical Affairs
Typically a job would require a certain level of education.
Employers hiring for the medical affairs job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Medical, Medicine, Science, Education, Pharmacy, Management, Life Sciences, Healthcare, Business, Nursing
Skills for Medical Affairs
Desired skills for medical affairs include:
Clinical trial methodology
Clinical operations
Regulatory requirements governing clinical trials and experience in development strategy and the design of protocols
Microsoft Office Suite
Regulatory
Risk management
Study execution
Project management tools
Regulatory submission and US and international guidelines
Study methodology
Desired experience for medical affairs includes:
Relevant clinical therapeutic experience preferred
Understands his/her audience
Is able to address issues/concerns in a clear, well-informed manner that engages others in a thoughtful discourse
Demonstrates ability to serve as corporate spokesperson
Proficient in office based computer skills including Word, Excel, PowerPoint
Act as therapy area expert to provide strategic medical input into the company decisions on specified therapeutic areas as required
Medical Affairs Examples
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Medical Affairs Job Description
Job Description Example
Our company is looking to fill the role of medical affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for medical affairs
- Gather competitive information and communicate through appropriate venues and channels
- Develop, support and participate in product testing, disease state training of internal and external customer needs
- Provide project administrative support to a team of about 10-15 people
- Provide cross-functional project coordination and support within a matrix organization
- Coordinate and track a variety of tasks/activities
- Provide ad-hoc support as and when needed
- Provide product and disease area information to external customers
- Activities within this role include effectively communicating with assigned stakeholders and developing new relationships within assigned stakeholders, contributing to process improvements, managing work flow efficiently, contributing to cost savings objectives
- For this contractor role specifically, preference given to candidates with an understanding of Medical Affairs and Investigator Sponsored Research Agreements (ISRs)
- Drafts and negotiates contracts for study needs and contributes to more complex and broadly applied contracts as assigned
Qualifications for medical affairs
- Bachelors degree in Pharmacy, Pharmacology, Pharmaceutics or Life Sciences
- Minimum 2 - 3 years relevant experience and candidate with more experience may be offered a higher position
- Develop and maintain strong scientific partnerships with key external experts and professional bodies
- Line management of existing medical advisors
- Develop comprehensive knowledge of disease state and product data
- Effectively represent Vanda Medical Affairs to external clients and vendors, with scientific credibility and effective negotiation skills (e.g., Medical Societies, Patient Groups, CME Vendors, PDR, ..)
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Medical Affairs Job Description
Job Description Example
Our company is growing rapidly and is hiring for a medical affairs. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for medical affairs
- Influence thought leadership with technical advocacy for best practice diagnostic testing, backed by evidence based veterinary medicine
- Whatever needs to be done to continue 30 years of diagnostic innovation for healthier pets!
- Schedule quarterly and ad hoc meetings for all products
- Create meeting minute template
- Liaise with Procurement and Accounts Payable representatives to initiate PO requests
- Submit invoices, and ensure timely payment
- Create concept and protocol approval letters, complete contract templates
- General system administration - Request and verify training, assign appropriate permissions within ISS tool
- Complete departmental one off projects
- Support the team to deliver key projects by gathering and analyzing data, contributing in meetings and executing various tasks
Qualifications for medical affairs
- Practical/ working knowledge of the Brand and Disease Area
- Business acumen and market knowledge is required
- Strong interpersonal skills – ability to interact with all levels within the organization
- MD, PhD, Pharm.D
- Ability to understand and effectively communicate scientific and medical information to both internal and external customers
- Strong scientific baseline knowledge in therapeutic area 1) Clinical doctor in the related TA (bachelor of clinical medicine degree or above) resident level at Tier III hospital (preferred) or resident to attending level at Tier II hospital
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Medical Affairs Job Description
Job Description Example
Our innovative and growing company is hiring for a medical affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for medical affairs
- Amend and submit registration dossier as necessary for country specific regulatory requirements and oversee submission of registration applications till to obtain approvals
- Assist in the preparation of responses to address significant safety and/or regulatory issues relating to our products
- Assist the Regulatory and Medical Affairs Manager
- Support internal investigations into allegations of non-compliance and coordinate the activities necessary to expeditiously resolve local regulatory dispute
- Provide technical support to respond to consumer and legal inquiries regulatory issues for our products marketed locally
- Maintain and report measures of product registration and regulatory compliance performance
- Prepare, maintain and update local product registration and regulatory compliance files
- Disseminates medical information in accordance with established department guidelines and regulatory guidances with recognition of legal ramification
- Work collaborativley and cross-functionally to ensure deadlines are met and projects are completed
- Ensure data and information is accurate
Qualifications for medical affairs
- Must have PRC experience (4 years), infectious disease therapeutic areas expertise highly valued, and Medical Affairs experience (4 years) in Pharmaceutical industry preferred
- Medicine Degree is a must
- Familiarity within the same field
- 3-5 years of administrative and team assistant expereince
- Rior exposure to project coordination / tracking activities and collaborations
- Must posses and independently apply proficient knowledge of company procedures and practices
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Medical Affairs Job Description
Job Description Example
Our company is searching for experienced candidates for the position of medical affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for medical affairs
- Develop clinical knowledge of PAH
- Respond to unsolicited medical information questions through verbal or written channels from healthcare providers (HCPs) and payer and managed healthcare organizations by utilizing the highest level of scientific data so that healthcare providers globally are able to make informed clinical decisions about company products in a safe & efficacious manner while adhering to business policies and processes
- Create and update standard medical information content on company products utilizing the highest level of evidence, critically evaluate the data with the focus that the information can be shared with healthcare providers by all company Local Operating Companies
- Create and update medical information payer content by collaborating and building a strong relationship with our partners (US Medical Affairs Leader, US Health Outcomes, Legal) so that payer and managed care organizations have the necessary resources they need to make decisions regarding company products
- Plan the database by actively reviewing the data dissemination plan for new and relevant company data so that medical information content is updated proactively resulting in the most current information in medical information resources for colleagues (Medical Information Scientists, US Medical Affairs Leaders, Medical Affairs Field Liaisons) to share with HCPs regarding company products
- Collaborate with Medical Affairs Field Liaisons to create topic specific presentations as requested by HCPs to share new information regarding a company product/disease state or help fulfill knowledge gaps
- Collaborate with internal business partners (e.g., Medical Affairs, Medical Affairs Field Liaisons and Commercial) to ensure the provision of medical information such as promotional materials, speaker presentations, and field training materials related to a company product or related disease state for medical accuracy and scientific balance is accurate and scientifically balanced during the promotional review process
- Contribute actively in a Therapeutic Area Team to discuss strategic priorities of company product(s), to ensure appropriate resources (e.g., medical information content) are available to meet the priorities
- IND Safety report receipt, processing, publishing and tracking and archiving for safety reports
- Ensure that key opinion leaders and organizations have access to relevant scientific information, and that insights gathered externally will be communicated to key cross-functional partners internally
Qualifications for medical affairs
- Must have advanced working knowledge of Microsoft Word, PowerPoint, Excel, and Microsoft Outlook/Calendar
- Proficient in English (written/spoken), any other language is an advantage
- Ability to maintain confidential information and treat appropriately
- Sense of ownership and result orientation
- Flexibility combined with tenacity to complete assigned tasks in high quality
- Fluent in professional English language
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Medical Affairs Job Description
Job Description Example
Our company is looking for a medical affairs. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for medical affairs
- Clinical Trail process
- Develops, reviews and follows up on clinical studies and medical projects initiated within Gastroenterology
- Responsible for planning, organizing and conducting US scientific advisory boards with world leading academic and clinical experts in Gastroenterology
- Work extensively with clinical customer base, particularly in peer-to-peer microscope slide reviews in medical education programs
- Communicate project information/customer interaction to internal stakeholders
- Performs review of medical data listings, Case Report Form (CRF) line and lab listings, and medical coding
- Performs analysis to identify trends within data, line, and lab listings
- Performs initial assessments for Medical Affairs Pre-Enrollment Review process
- Assists Medical Monitor(s) with creation of Medical Management Plans
- Works collaboratively with other staff to provide necessary clinical support services to facilities and medical staff
Qualifications for medical affairs
- Require undergraduate degree
- Preference for pharma development outsourcing experience, medical affairs experience a plus, ISR experience a BIG plus
- Preference for at least 2 years contracts or outsourcing experience, but not required
- Local talent only, must be onsite
- Bachelor's Degree or local equivalent Medical or Health-Science background (nursing preferred)
- High level of flexibility and ability to prioritize one's own work and others as it relates to the overall processes