MLR/ QA Specialist

Apolis; Bogotá; On-site; COP 109,521,027 - 164,281,541; Full time

Job summary

Apolis is seeking a talented MLR / QA Specialist in Bogotá, Colombia. The candidate will support the Medical, Legal and Regulatory review process for U.S. content and market access materials. Responsibilities include ensuring compliance with regulations, guiding teams based on feedback, and maintaining high output quality.

The ideal candidate will have medical education, experience in the pharmaceutical industry, strong communication skills in Portuguese, and be detail-oriented. Join Apolis for an opportunity to leverage your expertise in a multi-national setting.

Qualifications

• Intermediate understanding in the field of Respiratory & Immunology, cardiovascular, renal & metabolic, oncology and rare diseases.
• Ability to respond to a multi-brand volume of requests.
• Experience working in a big multi-national company.

Responsibilities

• Ensure compliance with US legislations and regulations.
• Guide the copy writing and design teams based on feedback.
• Maintain standard output quality through timely reviews.

Skills

Medical education

Up to 3 years of experience in pharmaceutical industry

Strong written and verbal communication skills in Portuguese

Detail oriented

Client-oriented attitude

Job description

MLR / QA Specialist

(Medical, Legal and Regulatory review process support and Quality Assurance)

***** is looking for a talented professional with copywriting experience support Medical, Legal and Regulatory review process steps related to content and market access materials for our brands in US. The role will work with medical, regulatory, legal and compliance guidelines. The ideal candidate should be able to anchor medical literature references, confirm the medical key messages are maintained, all data entries required are in place and reviewing common quality issues are detected before going into the MLR review.

Main responsibilities

• Ensure compliance to US legislations and regulations including internal policies, ensuring that content is supported by authentic and up-to-date references.
• Follow up and asset execution and guide the copy writing and design teams to interpret asset owners and reviewers feedback.
• Maintain a standard output quality through timely review and feedback to the copy writing and design teams.

Skills and experience

• Medical education, up to 3 years of experience in pharmaceutical industry, pharma advertising or health related companies
• Intermediate understanding in the field of Respiratory & immunology, cardiovascular, renal & metabolic , oncology and rare diseases
• Strong written and verbal communication skills in Portuguese, basic/intermediate business English fluency
• Client-oriented attitude with focus on creating strong long-term relationships with clients and ability to respond to a multi brand volume of requests
• Detail oriented, well organized and timeline driven
• Skilled to leverage upon technological tools to generate content
• Experience working within a big multi-national company in a matrix environment
• Up to date with the latest technical/scientific developments in the pharmaceutical industry