Associate Medical Writer

1-2 years

Not Disclosed

Remote, USA

15 May 22, 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

Essential Duties and Responsibilities:

Associate Medical Writer Responsibilities:

Collaborate with the Medical Writing, Statistics, and Scientific teams to prepare Expert Cardiac Safety Reports and Statistical Analysis Plans.
Create, edit, proofread, and finalize Expert Cardiac Safety Reports based on statistical analysis output and Scientific team conclusions.
Work with the Statistical team to develop, edit, and finalize Statistical Analysis Plans.
Conduct quality control checks on medical writing documents, ensuring accuracy in data results, conventions, grammar, and hyperlinks.
Actively participate in team meetings.
Maintain workload metrics for assigned deliverables.

Other Duties and Responsibilities:

Manage and communicate timelines for all deliverables related to Expert Cardiac Safety Reports and Statistical Analysis Plans.
Interpret and integrate information from source documents into writing tasks.
Assist in developing, coordinating, and maintaining quality standards and compliance with regulations.
Understand FDA/EMA regulations concerning clinical trial reporting.
Perform additional duties, assignments, or special projects as required.

Qualifications and Skills Needed:

Education:

Bachelor’s Degree in Science or Healthcare related field.

Experience:

1-2 years of previous experience in medical or scientific writing for publications, reports, or grant submissions.
Familiarity with interpreting statistical outputs.
Excellent English language skills with attention to detail.
Knowledge of clinical trials environment, regulations, and AMA style guidelines.
Strong organizational, analytical, and communication skills.
Intermediate to advanced knowledge of Windows Microsoft Office products.
Ability to work both independently and in a group setting, adapting to changing priorities.

Working Conditions:

Primarily computer work for extended periods.

The Department Head reserves the right to consider candidates with a combination of experience and education different from the qualifications listed above.

This job description is not exhaustive. Additional requirements and expectations may apply. Employees are expected to adhere to company policies and SOPs at all times.

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 endpoint technology solutions for clinical trials, having supported over 19,000 trials and 870 regulatory approvals. With Trial Anywhere™, Clario enables evidence generation across decentralized, hybrid, and site-based trial models. Operating in 30 facilities across nine countries, Clario's global team provides scientific, technological, and operational expertise for nearly 50 years.

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Associate Medical Writer

Job Description

Essential Duties and Responsibilities:

Associate Medical Writer Responsibilities:

Other Duties and Responsibilities:

Qualifications and Skills Needed:

Education:

Experience:

Working Conditions:

EEO Statement:

About Clario:

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