Medical Information Specialist
Galderma Laboratories

Job Info

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Company Overview
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com

Job Description
The Medical Information Specialist processes Medical Information (MI) requests received from external customers for all Business Units. This role works collaboratively with business and functional partners to facilitate the implementation of policies, procedures and practices related Medical Information.

Job Responsibilities

• 60% - Coordinate Medical Information (MI) activities for all business units (BUs; Aesthetics, Prescription, and Consumer)
  • Create standard (eg, MI Letters and Frequently Asked Questions, etc) and custom responses to communicate disease state, product information, and other general information to internal and external customers in a competent and timely manner and maintain responses in appropriate databases and systems (eg, MI library and call center database).
  • Collaborate with Medical BU representatives, other departments and GLLP affiliates, and applicable vendors to execute product related activities (eg, product launches, emerging literature, and clinical trial data) and represent MI in meetings.
  • Staff key scientific congresses as requested.
• 20% - Participate in training applicable vendors and partners about Medical Information.
  • Develop training materials and supportive documents (i.e., process document, forms, etc.).
  • Present training topics, such as product training to MI vendors.
• 10% - Monitor MI Call Center cases (including data entry, case documentation, responses, etc.) for specific department activities (e.g., product launches, in response to compliance issues, etc.) providing timely feedback to remediate findings.
• 10% - Update department processes to reflect company policies/contracts and strictly adhere to legal and regulatory guidelines for Medical Information compliance (i.e., applicable GLLP Standard Operating Procedures and Work Instructions and FDA, GCP, PhRMA, OIG, ACCME, and other relevant guidelines and regulations).
• Other duties as assigned

Minimum Requirements

• Bachelor's degree required; advanced degree in biomedical or life sciences preferred.
• Licensed health care professional (PhD, PharmD, RN, NP, PA) preferred
• Minimum of five (5) years medical or clinical related experience in the pharmaceutical, biotechnology, and/or medical devices industry, CRO (contract research organization) industry, and/or medical communications or writing agency.
• Pharmaceutical experience required.
• Knowledge of ICH, GCP, FDA, OIG, HIPAA and other applicable regulations.
• Experience managing major projects.
• Familiarity with clinical trial design and statistics and their application to the interpretation and presentation of clinical data.
• Experience with Corporate setting and the ability to think strategically and to model and guide compliant behavior.
• Successful track record demonstrating strong analytical and organization skills demonstrating the ability to drive process improvement and quality assurance.

• Ability to organize, prioritize, and maintain high quality work output in a fast-paced dynamic environment while working on multiple projects.
• Strong writing skills, with a demonstrated record of scientific/medical writing and familiarity with AMA Style Guide.
• Familiarity with scientific literature and proficiency with scientific literature databases (eg, MEDLINE, EMBASE, PubMed, etc.).
• Possess excellent written and verbal communication skills and ability to persuade with verbal and written communications involving multiple-disciplinary groups maintaining a high level of credibility and professionalism.

Other Important Information
The work environment characteristics and physical requirements described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing duties of this job, the employee may or may not be frequently/or occasionally required to:

• Stand; walk; sit; climb or balance; stoop; kneel; crouch; talk or hear; and taste or smell.
• Climb stairs or ride elevators.
• Lift and/or move up to 25 pounds.
• Use close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
• Manipulate keyboard or otherwise access computer, telephone and hand-held devices.
• Be exposed to outside weather conditions while going in and out of office buildings.
• Be exposed to moderate noise level usually in warehouse settings.
• Be exposed to moving equipment, mechanical parts, and/or high places; or moving between air-conditioned and non-air-conditioned environments.
• Travel requirements <10%

Employer's Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based upon your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

This job has expired.