Sr. Clinical Evaluation Medical Writer

Job Description

Duties and Responsibilities:

• Review and summarize scientific literature.
• Reports instances of complaints/adverse events from literature to GCH.
• Create responses for audit/submission queries.
• Maintains database of peer-reviewed literature.
• Appraise, analyze, summarize, and discuss clinical evidence from all the available sources.
• Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence.
• Develop state of the art on product family for its intended purpose.
• Create & maintain plans and reports for regulatory authorities.
• Review/approve other documentation for device development.
• Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.

Differentiating Factors:

1. Autonomy:

• Seasoned individual contributor.
• Works independently under limited supervision to determine and develop approach to solutions.
• Coaches and reviews the work of lower level specialists; may manage projects / processes.

2. Organizational Impact:

• May be responsible for entire projects or processes within job area.
• Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

3. Innovation and Complexity:

• Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
• Makes improvements of processes, systems or products to enhance performance of the job area.
• Analysis provided is in-depth in nature and often provides recommendations on process improvements.

4. Communication and Influence:

• Communicates with senior internal and external customers and vendors.
• Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

5. Leadership and Talent Management:

• May provide guidance, coaching and training to other employees within job area.
• May manage projects, requiring delegation of work and review of others’ work product.

Education and Experience:

• Bachelors with minimum 4 years of experience OR advanced degree with minimum 2 years of experience.
• Clinical Evaluation Report (CER) Writing Experience.
• Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Knowledge, Skills and Abilities:

• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• May have practical knowledge of project management.
• Strong Project Management skills.
• Ability to work with and manage cross-functional teams.