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Medical Information Specialist
Job Description
- Responsible for drafting/updating Global Response Letter and Guidance (GRL) for approved and pipeline AAA products under supervision of Head of Medical Information.
- Searches medical literature and company data on file to create comprehensive GRLs on core-titles of the product, submits preliminary GRLs to the GRL review and approval committee, follows review process and revises accordingly, archives the approved GRLs in the designated areas.
- Searches medical literature periodically and provides preliminary critical evaluation and summary of main published articles on the relevant subjects.
- Responsible for drafting responses to escalated medical information requests from local medical teams and following the review process, revise accordingly and submit them for approval according to standard operational procedures.
- Responsible of all GRL will be scientifically accurate and up-to-date information, and processed timely and archived systematically.
- Assists Head of Medical Information for Global Medical Information tasks according to standard operational procedures.
- Work in collaboration with GMA functions and Local Country Medical teams to drive the aligned and most upto date Medical Information strategy with Medical affairs team and report to Head of Medical Information.
Key Performance Indicators:
- Management of GRLs: Numbers of drafting/updating GRLs incorporating most up to date GMA Medical strategy, following up approval procedure and depositing GRLs timely and accurately, depositing the approved responses.
- Management of escalated medical information requests from local medical information team; Drafting the responses accurately and on-time, following-up the approval process, communicating with GMA functions and local country medical teams timely according to standard operational procedure.
- Management of Global Information System (e.g Minova-MIND)
- Monthly literature review.
EEO Statement
Minimum requirements
- Master’s degree (preferably in Life Sciences) or PharmD strongly preferred.
- 2+ years experience as Medical Information Specialist in the pharmaceutical industry preferred.
- Strong working knowledge of medical terminology, pathophysiology, pharmacology, regulations, and industry standards required.
- Ability to correctly identify inquirer’s question(s) and formulate and communicate an accurate response utilizing multiple resources for information which may require scientific interpretation.
- Past medical writing experience preferred.
- Experience in scientific/medical literature identification and evaluation
The Senior Medical Information Specialist is responsible for providing clinical information regarding Acorda’s marketed products. This individual is responsible for researching and writing responses to questions, and maintaining updated FAQ lists. He/she will also participate in medical review of promotional and scientific materials and assist in higher level departmental research projects.
- Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Maintains accurate, up-to-date, referenced FAQ responses for most commonly asked questions.
- Researches and writes Standard Response Letters or other responses to questions not available in the Medical Information database.
- Maintains and expands the internal literature library.
- Interprets and evaluates the published medical literature.
- Performs literature searches as necessary for regulatory compliance such as annual reports.
- Serves as an information resource on assigned project teams and for internal information requests.
- Recognizes and reports spontaneous adverse events to Acorda Drug Safety officer or designee.
- Performs all functions related to medical and promotional review.
- Assists in the monthly audit of medical inquiries for accuracy.
- Participates in internal advisory group meetings.
- Assists in the development of internal and external training and educational programs.
- Assists with writing of departmental SOPs.
- Prepares Drug Information Plan for marketed or new products.
- May contribute to the training and education of pharmacy students on rotation, PharmD fellows or Medical Information Specialist(s).
Education and/or Experience:
- Bachelor’s degree in pharmacy, life sciences or related field required.
- PharmD, RPh or R.N. preferred.
- Minimum of two to three years relevant experience required, can be combined with experience gained as a graduate of a drug information fellowship or residency from an accredited program.
- Prior health care experience and an understanding of physician, pharmacy, nursing, and other patient care practices.
Supervisory Responsibilities: None
Qualifications:
- Knowledge of U.S. regulatory standards related to pharmaceutical manufacturers’ communications and dissemination of medical information, drug surveillance, and guardrails around product promotion.
- Excellent written and verbal communication skills
- Detailed knowledge of pathophysiology, pharmacology, and overall treatment of disease states.
Computer Skills:
- Must be proficient in MS Office Suite.
- Proficiency in searching biomedical databases required
- Proficiency in using OVID, RightFind, and Medinquirer preferred.
Certificates, Licenses, Registrations: None required
Other Skills and Abilities:
- Ability to multi-task, adjust priorities and work autonomously.
- Excellent organizational skills and attention to detail.
- Ability to manage both day-to-day operations as well as project work in a fast paced environment.
- Ability to critically evaluate clinical literature including all aspects of clinical trial design and methodology, published clinical trials, case reports, internal reports, pharmaceutical investigations, and information from various media sources.
- Highly developed interpersonal skills.
- Self-motivated and must thrive on challenge.
- Ability to work as a member of a team to accomplish goals.
- Able to work effectively with outside service providers.
- Ability to maintain high level of ethical and compliance standards.
- Demonstrated ability to stay abreast of trends and new information in the profession.
Physical Demands:
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- This position requires minimal travel; average travel for this position is 5-l0% with some variation based upon the demands of the business imperatives.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
No specific work demands.
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Medical Information Specialist II- job post
Ashfield Engage has a long-standing partnership with a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses.
A frontline specialist responsible for delivering virtual or telephonic support to identified clients engaging customers, patients, and/or healthcare professionals, in a robust clinical dialogue. The specialist serves as a primary resource to provide drug/medical device product information.
This is your opportunity to join Ashfield Engage and represent a top biotechnology company!
What’s in it for you?
- Competitive compensation
- Excellent Benefits – accrued time off, medical, dental, vision, 401k, disability & life insurance, employee discounts/promotions
- Competitive environment with company wide recognition, contests and coveted awards
- Exceptional company culture
- Recognized as a Top Workplace USA 2021
What will you be doing?
- Completely and accurately document all Medical Information Requests, Adverse Events and Product Quality Complaints in compliance with Ashfield, Client and Federal guidelines and regulations
- Conduct study compliance calls to volunteers enrolled in clinical/medical research trials
- Enroll participants in educational seminars
- Provide patient support to patients enrolled in Patient Support Programs
- Collect demographic data and disposition for product, sample and literature fulfillment
- Maintain excellent quality and productivity standards for all client programs; adhere to program scripts and guidelines
- Accurately collect information required by individual programs and correctly capture in specific program databases
- Exhibit effective communication and tele-management skills
- Converse with callers in an empathetic manner and facilitate the callers in their ability to understand medical terminology, as needed
- Display flexibility within department to maximize utilization, including performing administrative and non-telecommunication duties as needed
- Adhere to all company policies and Standard Operating Procedures
- Possess effective organizational skills, including working on multiple projects simultaneously
- Must safeguard patient privacy and confidentiality by following the guidelines set forth in the Privacy and Security Rules of the Health Insurance Portability and Accountability Act (HIPAA)
- Update and submit resume upon requests for audits
What do you need for this position?
- Current US healthcare professional license: RN
- Excellent verbal, written and listening communication skills
- Competency with a computer keyboard and mouse
- Competency with Call Center Telephone Technology
- Pleasant telephone manner
- Ability to work both independently and within a group setting
- Results oriented, excellent organizational skills and ability to work cross-functionally
- Must have stable, reliable, high speed home internet.
- Must have a designated separate home office space that is quiet and away from distractions
About Ashfield Engage
Ashfield Engage, part of UDG Healthcare plc, is a global leader in commercialization services for the healthcare industry. We partner with our clients across Advisory, Healthcare Communications, Commercial, Patient Solutions and Medical Affairs to build creative, scalable and tailored health solutions that are executed flawlessly, to deliver positive outcomes for patients.
Our mission is to partner with our clients, improving lives by helping healthcare professionals and patients get the medicines, knowledge and support they need.
To learn more about Ashfield Engage, visit us at:https://ashfieldengage.com/
Ashfield Engage is proud to be an equal opportunity employer. Individuals seeking employment at Ashfield are considered without regards to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition (including pregnancy, childbirth, or related medical conditions), mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. Further, pursuant to applicable local ordinances, Ashfield will consider for employment qualified applicants with arrest and conviction records.
Ashfield Engage is an equal opportunity employer M/F/V/D. We appreciate your interest in our company, however; only qualified candidates will be considered.