Post-Market Safety Evaluation Principal Medical Writer

6-8 years

Not Disclosed

Minneapolis and St. Paul, Minnesota.

10 May 27, 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: Post-Market Safety Evaluation Principal Medical Writer

Company Description:

Abbott is a global healthcare leader dedicated to helping people live fuller lives at every stage. With a diverse portfolio spanning diagnostics, medical devices, nutritionals, and generic medicines, Abbott's innovations touch millions worldwide.

About the Opportunity:

Abbott is seeking a seasoned Post-Market Safety Evaluation Principal Medical Writer to join its Medical Device division in either St. Paul, MN, or Plano, TX. The ideal candidate will bring a wealth of experience in Post-Market Safety Evaluation (PMSE), with a focus on compliance with EU and Canada regulatory guidelines. They will provide technical and strategic expertise in the post-market phase, managing various projects and timelines effectively.

Responsibilities:

Facilitate communication between internal stakeholders (Regulatory Affairs, Product Performance Group, Sales, Marketing, Quality Engineering, etc.) and external vendors (CROs, Medical Writers).
Propose and implement process improvements, oversee timelines, manage project risks, and develop recommendations for management.
Create, manage, or participate in timelines and budgets for PSUR/PMS Reports, selecting providers, managing vendor contracts, and ensuring budget adherence.
Maintain current understanding of clinical/PMS data and risk management.
Support regulatory submissions and communications, including interactions with Regulatory Affairs.
Develop and maintain PSUR/CASR/PMS Report/PMS Plan DOPs/SOPs and associated documentation, leading process improvements as necessary.
Independently create and maintain PSURs, PMS Reports, CASRs, and PMS Plans for Abbott products, incorporating data from various sources.
Participate in audits and root cause analysis, as needed.

Required Qualifications:

Bachelor’s Degree
8 years of experience in the medical device industry
6 years of significant medical writing experience

Preferred Qualifications:

Advanced degree
Strong written, oral, interpersonal, and negotiation skills
Leadership competency, including project management skills
Ability to adapt to shifting priorities and competing demands
Strong attention to detail

Application Details:

Apply now through the company website.
Learn more about health and wellness benefits at abbottbenefits.com.
Follow Abbott on social media for updates and insights.

Compensation:

The base pay for this position ranges from $95,000.00 to $190,000.00, with variations depending on location.

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Post-Market Safety Evaluation Principal Medical Writer

Job Description

Job Title: Post-Market Safety Evaluation Principal Medical Writer

Company Description:

About the Opportunity:

Responsibilities:

Required Qualifications:

Preferred Qualifications:

Application Details:

Compensation:

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