Senior Associate Scientific Communications
3 days ago
Role Description:
The Scientific Communications MLR Technical Reviewer is responsible for checking all medical content for data and scientific accuracy, and reference appropriateness for materials submitted through the Medical, Legal, and Regulatory (MLR) process. This role ensures that all content adheres to Amgen's scientific and compliance standards, while supporting timely review and approval of assets that inform and engage healthcare providers, patients, and internal stakeholders.
Working closely with the US Scientific Communications MLR Reviewer, the Technical Reviewer brings scientific expertise, attention to detail, and compliance awareness to evaluate the submissions. This role contributes to the quality and consistency of Amgen's communications by safeguarding scientific integrity across materials.
Roles & Responsibilities:
Conducting a review of proactive materials for scientific accuracy and reference appropriateness
Reviewing the material and ensuring appropriate medical context, scientific balance, and compliance are maintained in submitted content
Ensuring the timely and high-quality review of MLR materials within established SLAs and agreed-upon timeframes
Collaborating with the US Scientific Communication MLR Reviewer to ensure clear guidance on action items
Working within Amgen's MLR systems to apply clear review comments per company process
Conducting and participating in knowledge-sharing sessions to align on therapeutic areas, products, and review best practices
Providing scientific guidance to cross-functional teams regarding appropriate interpretation and use of data in promotional and medical content
Supporting standardization of review practices, templates, and criteria to drive efficiency and consistency across reviews
Staying current on therapeutic area developments, industry guidelines, and regulatory requirements relevant to MLR reviews
Contributing to process improvement initiatives and adoption of new technologies that enhance review workflows
Basic Qualifications and Experience:
Doctorate degree & 2 years of directly related experience
OR
MBBS or Master's degree & 4 years of directly related industry experience
OR
Bachelor's degree & 4 years of directly related industry experience
OR
Associate's degree & 6 years of directly related industry experience
Functional Skills:
Preferred Qualifications:
Doctorate degree in life sciences, pharmacy, biomedical sciences, or a related field
5+ years of experience in medical review, medical writing, scientific communications, publications, or related industry role
Familiarity with the MLR review process and regulatory requirements for medical and promotional materials
Strong ability to critically evaluate data, references, and claims for scientific accuracy and compliance
Prior experience with content management and MLR review systems (e.g., Veeva PromoMats or equivalent)
Excellent attention to detail and organizational skills to manage multiple, concurrent submissions under tight timelines
Strong written and verbal communication skills to interact effectively with cross-functional stakeholders
Knowledge of therapeutic areas such as oncology, cardiovascular, inflammation, bone, and rare diseases is a plus
Understanding of US compliance, copyright, and transfer-of-value requirements
Competencies:
Scientific Integrity: Upholds rigorous standards in data accuracy and interpretation
Collaboration: Works effectively with cross-functional global teams in MLR review cycles
Attention to Detail: Ensures consistency, accuracy, and compliance in content review
Time Management: Prioritizes high-volume review workload and meets critical deadlines
Adaptability: Adjusts to evolving review practices, systems, and regulatory expectations
Compliance: Demonstrates commitment to integrity in all aspects of review work
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Hyderabad, Telangana, India Amgen Full time ₹ 20,00,000 - ₹ 25,00,000 per yearRole Description:The Scientific Communications MLR Technical Reviewer is responsible for checking all medical content for data and scientific accuracy, and reference appropriateness for materials submitted through the Medical, Legal, and Regulatory (MLR) process. This role ensures that all content adheres to Amgen's scientific and compliance standards, while...
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