Senior Medical Information Writer

2-5 years

Not Disclosed

Hyderabad

10 Aug. 13, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Medical Information Writer

Main Responsibilities:

Scientific Documentation:
- Conduct literature searches, reviews, and data extraction from scientific literature.
- Generate evidence-based, accurate, and fair-balanced summaries for the creation and maintenance of scientific response documents for products in designated therapeutic areas.
- Adapt global scientific response documents for assigned countries.
- Develop responses to escalated inquiries for assigned countries.
- Contribute to US NDA Annual Reports and US compendia reviews.
Content Development:
- Maintain Therapeutic Area expertise.
- Review content created by peer writers.
- Collaborate with Global Medical Information teams to execute content plans.

People Management:

Stakeholder Relations:
- Maintain effective relationships with end stakeholders (Medical scientific community) within the allocated Global business unit and product.
- Interact with stakeholders in medical and pharmacovigilance departments.
- Assist other medical information writers in developing knowledge and sharing expertise.

Performance:

Deliverables:
- Provide scientific response documents, US NDA Annual Reports, and US compendia reviews as per agreed timelines and quality standards.

Process:

Expertise and Implementation:
- Act as an expert in medical information writing and stay updated on regulatory requirements for supported countries.
- Assist in conducting comprehensive medical writing needs analyses.
- Implement content plans and associated activities for assigned countries.
- Work with selected vendors to deliver required deliverables as per defined processes.
- Design action plans based on end-customer feedback and improve course content and delivery.

Stakeholder Engagement:

Collaboration:
- Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing deliverables.
- Liaise with the Medical department to prepare relevant and customized deliverables.

About You:

Experience:
- Over 5 years of experience in medical writing within the pharmaceuticals/healthcare industry or equivalent clinical experience.
- At least 2-3 years of direct medical information experience in a pharmaceutical company.
Soft Skills:
- Stakeholder management.
- Effective communication skills.
- Ability to work independently and collaboratively within a team.
Technical Skills:
- Medical operational excellence.
- Time and risk management skills.
- Excellent technical (medical) editing and writing skills.
- Knowledge of literature evaluation and multilevel response development.
Education:
- Advanced degree in life sciences, pharmacy, or a similar discipline (e.g., PharmD, Ph.D., Master’s in Science, MBA, or equivalent).
Languages:
- Excellent command of the English language (spoken and written).

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Senior Medical Information Writer

Job Description

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