Job Title: Senior Manager, Medical Writing Services
Location: SAS Nagar (Mohali), India
Additional Locations: Bengaluru, Karnataka, India; Hyderabad, Telangana, India; SAS Nagar (Mohali), Punjab, India
Job ID: R0000031270
Category: Medical Writing
Date Posted: 02/17/2025
Company Overview:
Our organization is committed to excellence in the medical writing field, providing comprehensive services to the pharmaceutical and healthcare industries. We are seeking a highly skilled Senior Manager, Medical Writing Services to join our team and lead our medical writing department. The ideal candidate will have a strong background in medical writing, team leadership, and client management to support the growth of our medical writing services.
Job Overview:
The Senior Manager, Medical Writing Services is responsible for managing and overseeing medical writing projects, mentoring team members, liaising with clients, and ensuring the successful completion of projects within scope, on time, and to the highest quality. This position requires a strong understanding of drug safety, regulatory guidelines, and medical writing best practices. You will be leading teams, managing client relationships, and contributing to business development efforts.
Key Responsibilities:
Line Management and General Management:
Supervise and mentor team members, including hiring, training, performance evaluations, and career development.
Ensure adherence to departmental procedures, health authority guidance, and regulations.
Validate quality and training compliance.
Manage performance and foster a collaborative and motivating work environment.
Attend and chair manager meetings, providing leadership and guidance.
Oversee budgets, expenses, and purchase orders as authorized.
Client Liaison/Service:
Build and maintain strong client relationships, ensuring satisfaction and confidence.
Implement key performance indicators (KPIs) and continuous improvement activities to optimize performance.
Participate in the proposal generation process, providing strategic insights and project planning intelligence.
Respond to client dissatisfaction incidents and provide feedback to senior management.
Project Management:
Manage stakeholder relationships and monitor project timelines, ensuring timely and quality deliverables.
Set clear objectives for the medical writing team, assess progress, and provide leadership to meet client expectations.
Propose creative solutions to address shifting timelines and staffing requirements.
Oversee budgeting and resource management to maximize profitability while maintaining high-quality outputs.
Contribute to process improvements, SOP development, and internal/external audits.
Document Writing and Consultancy:
Gather, analyze, and finalize aggregate safety reports, clinical study report narratives, and other related documents with minimal supervision.
Advise on regulatory issues related to aggregate safety reports and CSR narratives.
Ensure compliance with ICH, GVP, FDA, EMA, and other guidelines.
Signal Detection and Management:
Perform qualitative and quantitative signal detection reviews from various sources.
Lead signal detection activities and collaborate with the Global Safety Operations (GSO) team.
Quality Control:
Ensure all medical writing projects are completed on time, within scope, and with the highest quality standards.
Provide technical leadership, ensuring compliance with regulatory guidelines.
Training and Compliance:
Stay updated on industry trends and regulatory advancements.
Develop and deliver training to enhance team writing quality and project management.
Provide mentoring and knowledge transfer to junior team members.
General Management:
Participate in departmental committees and promote teamwork.
Maintain a positive, results-oriented work environment and manage project coverage as needed.
Promote the medical writing profession and contribute to the organization's strategic goals.
Skills and Competencies:
Interpersonal Skills: Strong negotiation, communication, and relationship-building abilities.
Project Management: Ability to manage multiple projects, prioritize tasks, and meet deadlines.
Leadership: Strong team leadership and mentoring skills to manage performance and build a high-performing team.
Analytical Thinking: Ability to analyze complex issues and propose data-driven solutions.
Client-Focused: Ability to build and maintain strong client relationships and drive repeat business.
Knowledge and Experience:
Related experience in Regulatory/Pharmacovigilance or a related field.
Expertise in drug safety, the drug development process, and applicable regulatory guidelines.
Proven experience in managing aggregate safety reports writing projects.
Strong understanding of people management and experience in a billable service industry.
Advanced knowledge of Microsoft Office (Word, Excel), document management systems, and collaborative authoring tools.
Education:
A degree in Life Sciences, Health, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics).
A degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing is advantageous.
Additional Information:
Travel: Occasional travel may be required.
Fluency in English (written and spoken) is essential.
This role offers the opportunity to be part of a dynamic team that plays a crucial role in the regulatory and clinical writing space. If you have a strong medical writing background with leadership experience, this could be a great opportunity to contribute to a growing team and help shape the future of medical writing services.
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