Associate Manager, Safety Medical Writing

Parexel

0-5 years

Preffered by Company

Mohali

10 Sept. 3, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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

Position: Associate Manager, Safety Services (SS)

Role Overview:

The Associate Manager, Safety Services, plays a crucial role in overseeing and supporting the writing and management of aggregate safety reports, clinical study report (CSR) narratives, and signal detection activities. This role involves managing project resources, leading a team of safety report writers, and acting as a Process Manager for designated parts of the overall process. You will also engage in client interactions, proposal generation, and contract reviews, contributing to the success of safety services projects.

Key Responsibilities:

Line Management and Team Oversight:
- Supervise, mentor, and manage safety services staff, including hiring, training, performance evaluations, and career development.
- Ensure adherence to departmental procedures, health authority regulations, and quality standards.
- Oversee time management and quality compliance for team members.
- Handle performance issues, including coaching and implementing improvement plans or terminations if needed.
Client Liaison and Service:
- Build and maintain strong client relationships, ensuring their expectations are met and providing high-quality service.
- Incorporate client feedback into performance metrics and improvement strategies.
- Contribute to proposal development by assessing scope, estimating hours, and participating in client meetings.
Project Management:
- Manage project objectives, timelines, and team performance.
- Communicate project scope, expectations, and goals clearly to team members.
- Monitor progress, adjust strategies as needed, and provide updates to safety services management.
- Propose solutions for shifting timelines and resource needs.
Subject Matter Expertise and Process Improvement:
- Author and review aggregate safety reports and CSR narratives, ensuring compliance with regulatory guidelines.
- Contribute to process development, budgeting, and financial monitoring.
- Analyze and improve efficiency in processes and staff training.
- Attend and respond to audits, providing input on process improvements.
Signal Detection and Management:
- Perform signal detection and analysis, managing the end-to-end signal management process.
- Conduct qualitative and quantitative reviews from various data sources.
Quality Control and Compliance:
- Ensure timely, high-quality delivery of reports in line with client and regulatory standards.
- Provide technical leadership and maintain knowledge of current guidelines and SOPs.
- Develop and present training materials to enhance writing quality and project management.
General Duties:
- Maintain a positive work environment, promote teamwork, and handle confidential issues professionally.
- Provide coverage for SS management in their absence and contribute to departmental activities as needed.
- Promote the medical writing profession and represent Parexel internally and externally.

Skills and Qualifications:

Experience:
- Proven experience in regulatory or pharmacovigilance medical writing.
- Broad experience managing aggregate safety report projects and familiarity with drug safety guidelines.
- Previous line management experience, preferably in a billable service industry.
Education:
- Bachelor’s or advanced degree in life sciences, healthcare, or biomedical sciences (e.g., Pharmacy, Biochemistry, Biotechnology).
- Degrees in Medicine, Dentistry, Physiotherapy, or Experimental Medicine are advantageous.
Skills:
- Excellent interpersonal, negotiation, and communication skills.
- Ability to manage multiple tasks, prioritize workloads, and adapt to changing priorities.
- Competence in project management, resource management, and productivity metrics.
- Advanced proficiency in Microsoft Office (Word, Excel) and familiarity with document management systems.
Additional Requirements:
- Fluent in written and spoken English.
- Ability to travel as needed.

Why Join Us?

At Parexel, we offer a dynamic environment where you can lead and grow in your career. We value inclusivity, collaboration, and continuous learning, and we support your professional development through mentoring, training, and career advancement opportunities. Join us to make a meaningful impact on patients' lives while advancing your career in a supportive and innovative workplace.

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Associate Manager, Safety Medical Writing

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