Senior Medical Writer / Senior Project Manager, Clinical Evaluation

3-5 years

$83,600.00 – $167,200.00.

Santa Clara

10 Dec. 4, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences/PharmD/mPhD, or MD 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: Senior Medical Writer / Senior Project Manager, Clinical Evaluation

Location: Santa Clara, California, United States
Category: Medical and Clinical Affairs

About Abbott

Abbott is a global healthcare leader, dedicated to improving lives with innovative technologies in diagnostics, medical devices, nutrition, and branded generic medicines. With over 114,000 employees across 160+ countries, Abbott offers life-changing solutions for a healthier future.

Why Join Abbott?

Career Growth: International career development opportunities.
Comprehensive Benefits: Free medical coverage via the HIP PPO plan, excellent retirement plans, and tuition reimbursement.
Recognition: Named a top workplace for diversity, working mothers, and scientists.
Impactful Innovation: Develop life-enhancing medical device technologies helping over 10,000 people daily.

The Opportunity

As a Senior Medical Writer/Project Manager for Vascular Clinical Evaluation Products, you will play a critical role in regulatory submissions for CE Marking of new and existing devices under EU MDR guidelines. This position combines expertise in scientific writing, project management, and regulatory compliance, contributing to both new product development and lifecycle evaluation.

Reporting To: Senior Manager, Clinical Evaluations Global Regulatory Operations.

Key Responsibilities

Clinical Evaluation Documentation

Independently create and maintain Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCPs), and other regulatory documents.
Analyze clinical data, including investigations, literature, and post-market evaluations, for safety and performance evidence.
Review and align documentation such as IFUs, patient guides, risk management files, and training materials.

Project Management

Use project management tools to define timelines, track deliverables, and manage risks.
Communicate project updates, risks, and mitigation strategies effectively with cross-functional teams.
Oversee document exchanges between stakeholders, including internal teams and external vendors.

Regulatory Compliance and Support

Stay updated on guidelines and provide strategic guidance on regulatory requirements for clinical data.
Lead responses to notified body questions during regulatory submissions.
Support audits, root cause analysis, and corrective actions to ensure compliance with EU MDR standards.

Data Analysis and Strategy

Interpret clinical, risk, and scientific data to support regulatory submissions.
Identify and adapt to shifting priorities in regulatory and project requirements.

Required Qualifications

Education: Bachelor’s degree in Science, Medical Technology, or a relevant technical discipline, or equivalent experience.
Experience:
- Minimum 3 years in R&D, technical product development, or quality roles in the healthcare industry.
- Proficiency in writing and managing technical documentation for medical devices or related fields.
- Experience in complaint handling, diagnostic instrumentation, or medical technology.
Skills:
- Strong communication, project management, and analytical skills.
- Ability to manage multiple priorities and meet tight deadlines.

Preferred Qualifications

Advanced degrees (e.g., Master’s, PharmD, PhD, or MD).
Experience with CER writing, MEDDEV 2.7/1 Rev 4, MDR submissions, and cardiovascular devices.
Familiarity with regulations (MDR 2017/745, ISO standards) and terminology related to medical devices.
Project management certification (e.g., RAC, PMP) is a plus.

Compensation and Benefits

Base salary range: $83,600 – $167,200 (may vary by location).
Extensive health and wellness benefits, retirement plans, and educational support.

Explore a career where your contributions drive innovation and improve lives globally.
Apply Now to join Abbott’s mission of creating a healthier, fuller future.

Learn more:

Abbott Benefits
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