Job Title:
Associate Manager, Safety Medical Writing
Location:
SAS Nagar (Mohali), India
Additional Locations: India – Bengaluru; India – Hyderabad (Mindspace 20)
Company:
Parexel
Overview:
The Associate Manager, Safety Medical Writing is responsible for leading and supporting safety services including aggregate report writing, clinical study report (CSR) narratives, and signal detection/management. The role includes staff supervision, project oversight, client liaison, and continuous process improvement, with a strong focus on regulatory compliance, team mentorship, and quality deliverables.
Key Responsibilities:
Line & General Management (If Applicable):
Hire, train, evaluate, mentor and supervise safety medical writing staff.
Ensure training and quality compliance.
Monitor team performance, address underperformance, and manage team morale.
Attend and lead internal meetings, authorize expenses, and participate in operational decisions.
Client Engagement:
Build strong, collaborative client relationships.
Contribute to proposal development and provide inputs on scope and hours estimation.
Represent the department in business development meetings and client presentations.
Project & Process Management:
Define project goals, communicate expectations, and monitor timelines.
Ensure quality and timely delivery of safety reports and CSR narratives.
Provide strategic planning, task delegation, and team leadership.
Capture and share project learnings for process improvement.
Forecast resources and contribute to performance evaluation.
Medical Writing & Signal Detection:
Author and review aggregate safety reports and CSR narratives per global guidelines (ICH, GVP, FDA, EMA).
Perform and lead signal detection and analysis using regulatory and internal data sources.
Manage the end-to-end signal detection and assessment lifecycle.
Quality Control & Compliance:
Ensure high-quality, on-time delivery aligned with regulatory requirements.
Participate in audits and contribute to SOP development.
Analyze performance metrics and drive process improvements.
Training & Development:
Stay updated on regulatory trends.
Create and deliver training modules for SS staff.
Mentor team members on writing quality and project execution.
General Duties:
Model teamwork, integrity, and professionalism.
Step in as coverage for other SS managers when required.
Support other senior-level tasks as needed with proper guidance.
Skills & Competencies:
Strong leadership, communication, and interpersonal skills.
Deadline- and detail-oriented with excellent project management abilities.
Ability to prioritize, multitask, and work independently under pressure.
Strong judgment, analytical, and problem-solving skills.
Professionalism in handling confidential data and sensitive issues.
Client-focused mindset and business awareness.
Adaptability to matrix environments and evolving business needs.
Knowledge & Experience:
Proven experience in pharmacovigilance, safety writing, or related roles.
Understanding of global regulatory environments and safety reporting requirements.
Experience in project management and business development.
Proficiency in Microsoft Office (Word, Excel); familiarity with document management systems (e.g., SharePoint) and databases (e.g., MS Access).
Willingness to travel and fluency in English (spoken and written).
Education:
Degree in Life Sciences, Health Sciences, Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
Degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing with patient exposure is an added advantage.
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