Senior Medical Writer / Senior Project Manager, Clinical Evaluation

Abbott

3+ years

$83,600.00 – $167,200.00

Santa Clara

10 Nov. 25, 2024

Job Description

Job Type: Full Time Education: RN/PhD/MD/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Abbott - Senior Medical Writer/Project Manager (Vascular Clinical Evaluation Products)

Company Overview: Abbott is a global healthcare leader with a broad portfolio of life-changing technologies in diagnostics, medical devices, nutritionals, and branded generic medicines. Abbott's innovations help people live healthier lives across 160 countries. With a focus on continuous improvement and new breakthroughs, Abbott is dedicated to enhancing the health of people worldwide.

Position Overview:

The Senior Medical Writer/Project Manager (Vascular Clinical Evaluation Products) plays a critical role in supporting regulatory affairs submissions for CE Marking of new medical devices and maintaining CE Marks for existing devices. This position involves a deep understanding of clinical evaluation processes, regulatory guidelines, and product knowledge to develop and maintain Clinical Evaluation Reports (CERs) and related documents for medical devices. As a subject matter expert, this person will guide medical writers and work cross-functionally to manage the necessary documentation and regulatory requirements throughout a device’s lifecycle.

Key Responsibilities:

Clinical Evaluation Documentation:
- Independently create and maintain Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Summary of Safety and Clinical Performance (SSCPs).
- Identify and evaluate clinical evidence from clinical investigations, literature, post-market surveillance, and clinical evaluations.
- Analyze results to support product applications and submissions, including responding to Notified Body questions during reviews.
Regulatory and Compliance:
- Ensure alignment of risk information across documents such as Instructions for Use (IFUs), patient guides, and clinical study reports.
- Review and interpret clinical and scientific data in preparation for regulatory submissions.
- Provide regulatory guidance on clinical data requirements for new product development and sustaining teams.
Project Management & Communication:
- Lead or participate in the development of timelines and deliverables, using project management tools to track progress and risks.
- Clearly communicate project timelines, risks, and mitigation strategies to internal and external stakeholders.
- Facilitate document exchange between cross-functional teams (Regulatory Affairs, R&D, Clinical R&D, Sales, Marketing, etc.) and external vendors (e.g., CROs).
Collaboration & Audit Support:
- Collaborate with cross-functional teams to ensure timely and efficient clinical evaluations.
- Participate in audits and respond to audit findings, contributing to corrective and preventive actions when needed.

Required Qualifications:

Education: Bachelor’s degree in Science, Medical Technology, or a relevant technical discipline, or equivalent education and experience.
Experience:
- Minimum of 3 years of relevant experience in areas such as R&D, Technical Product Development, or Quality within the healthcare industry.
- Experience writing and managing engineering and technical documentation, including CERs, in the context of medical devices and regulatory submissions.
- Strong project management skills with the ability to handle multiple projects and meet deadlines.
- Excellent written, verbal, and interpersonal communication skills.

Preferred Qualifications:

Education: Bachelor’s degree in Life Sciences; Master’s degree, RN, PharmD, PhD, or MD.
Experience:
- Experience in writing CERs and related documents in accordance with MEDDEV 2.7/1 Rev 4, MDR submissions, and ISO standards.
- Understanding of medical device regulations (MDD 93/42/EEC, MDR 2017/745, ISO 14971, ISO 13485) and clinical trial processes.
- Project management and/or leadership experience.
- Technical writing experience in medical or pharmaceutical industries.
- Experience in Cardiovascular devices.
- Certifications such as RAC or PMP are a plus.

What Abbott Offers:

Career Development: Opportunities to grow your career within a global healthcare leader.
Benefits:
- Free medical coverage for employees through the Health Investment Plan (HIP) PPO.
- Excellent retirement savings plan with a high employer contribution.
- Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit.
Recognition: Abbott is recognized as one of the best companies to work for, including for diversity, working mothers, female executives, and scientists.

Salary Range:

Base pay for this position is between $83,600.00 and $167,200.00, with location-specific variations.

This is a significant opportunity to join a leading healthcare company and contribute to the safety and performance evaluation of cutting-edge medical devices. The role provides a blend of scientific expertise, regulatory knowledge, and project management, ensuring critical regulatory submissions are successfully completed for new and existing medical devices.

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Senior Medical Writer / Senior Project Manager, Clinical Evaluation

Job Description

Abbott - Senior Medical Writer/Project Manager (Vascular Clinical Evaluation Products)

Position Overview:

Key Responsibilities:

Required Qualifications:

Preferred Qualifications:

What Abbott Offers:

Salary Range:

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