Associate Medical Writer

1-2 years

Not Disclosed

Remote, USA

12 May 21, 2024

Job Description

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

Job Title: Associate Medical Writer

Essential Duties and Responsibilities:

Prepare Expert Cardiac Safety Reports and Statistical Analysis Plans in collaboration with the Medical Writing, Statistics, and Scientific teams.
Create, edit, proofread, and finalize Expert Cardiac Safety Reports based on statistical analysis output and final conclusions of the Scientific team.
Collaborate with the Statistical team to create, edit, and finalize Statistical Analysis Plan(s).
Perform quality control checks of documents, ensuring accuracy in data results, grammar, and formatting.
Actively participate in team meetings and maintain workload metrics for assigned deliverables.

Other Duties and Responsibilities:

Manage and communicate timelines for deliverables including Expert Cardiac Safety Reports, Statistical Analysis Plans, and other outputs.
Interpret key information from source documents such as study protocols, investigator brochures, and internal study plan documents.
Assist with development, coordination, maintenance, and compliance of quality standards including SOPs, SWIs, and Playbooks/Checklists.
Understand FDA/EMA regulations related to clinical trial reporting.

Qualifications and Skills:

Education: Bachelor’s Degree in Science or Healthcare related field
Experience: 1-2 years of experience in medical or scientific writing for publications, reports, or grant submissions. Familiarity with interpreting statistical outputs.
Language Skills: Excellent English language skills (writing, reading, verbal) with attention to detail.
Knowledge: Understanding of clinical trials environment, regulations, and AMA style guidelines.
Technical Skills: Intermediate to advanced knowledge of Windows Microsoft Office products.
Communication: Strong organizational, analytical, and communication skills.
Work Environment: Computer work for long periods of time.

Additional Information:

The Department Head may consider hiring personnel with a combination of experience and education.
This job description may not include all requirements and expectations, and employees are expected to adhere to company policies and SOPs.

EEO Statement:

Clario is an equal opportunity employer, evaluating qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

About Clario:

Clario delivers leading endpoint technology solutions for clinical trials, enabling pharmaceutical, biotech, and medical device partners to transform lives. With experience from over 19,000 clinical trials and a global team of experts, Clario provides rich clinical evidence across all trial models through Trial Anywhere™ technology.

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Associate Medical Writer

Job Description

Job Title: Associate Medical Writer

Essential Duties and Responsibilities:

Other Duties and Responsibilities:

Qualifications and Skills:

Additional Information:

EEO Statement:

About Clario:

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