Senior Manager, Medical Writing Services

3+ years

Not Disclosed

Mohali

10 March 2, 2025

Job Description

Job Type: Full Time Education: 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

Job Title: Senior Manager, Medical Writing Services

Location: Sahibzada Ajit Singh Nagar, Punjab, India
Employment Type: Full-Time (On-Site)

Key Accountabilities:

Line Management and General Management:

Supervise and mentor line reports, including hiring, training, performance evaluations, compensation recommendations, and promotions.
Ensure compliance with departmental procedures and health authority regulations.
Validate quality and training compliance.
Ensure appropriate billable time for line reports.
Provide situational leadership, delegation, and accountability.
Manage employee performance, retention, and talent development.
Attend and chair manager meetings as needed.
Approve expenses, invoices, and purchase orders as authorized.

Client Liaison/Service:

Maintain collaborative client relationships to promote satisfaction and confidence.
Implement key performance indicators (KPIs) for continuous improvement.
Respond to client feedback and dissatisfaction appropriately.
Assist in proposal generation and strategic project planning.
Provide assessments of service scope and estimated effort.
Support business development efforts and identify new business leads.

Industry Experience Application:

Understand client challenges and propose strategic solutions.
Utilize industry awareness to identify new opportunities for clients.

Project Management:

Manage stakeholder relationships, partnerships, and operations.
Set clear objectives and monitor team performance.
Oversee project progress, ensuring timelines and deliverables are met.
Provide leadership, strategic planning, and resource management.
Identify and implement creative solutions for staffing and scheduling needs.

Process Development and Improvement:

Ensure efficient budgeting and financial monitoring.
Stay updated on and contribute to SOPs and guidelines.
Analyze workflow efficiency and propose improvements.
Provide regulatory guidance on safety report writing.
Participate in internal and external audits.

Authoring and Consultancy:

Develop and finalize safety reports, CSR narratives, and other regulatory documents.
Provide expert guidance on regulatory requirements (ICH, GVP, FDA, EMA, etc.).

Signal Detection and Management:

Conduct qualitative and quantitative signal detection analysis.
Manage signal tracking, assessment, and review meetings.
Ensure adherence to SOPs and regulatory guidelines.

Quality Control:

Ensure timely and high-quality project completion.
Provide technical leadership for regulatory compliance.

Training and Compliance:

Stay updated on regulatory advancements and industry trends.
Develop training materials and mentor staff.
Present technical knowledge to improve writing efficiency.

General Responsibilities:

Participate in process improvement and departmental committees.
Foster a positive, results-oriented work environment.
Provide leadership coverage when required.
Represent and promote the medical writing profession.

Skills and Competencies:

Strong interpersonal, negotiation, and communication skills.
Ability to work independently in a fast-paced environment.
Exceptional organizational and multitasking abilities.
Experience in leadership, decision-making, and client management.
Logical thinking and problem-solving skills.
Client-focused approach with business acumen.
Proficiency in Microsoft Office and document management systems.

Knowledge and Experience:

Experience in Regulatory/Pharmacovigilance or related fields.
In-depth knowledge of drug safety, development processes, and regulatory guidelines.
Proven track record in safety report writing and project management.
Business development experience preferred.
Ability to travel as required.
Fluent in written and spoken English.

Education:

Required: University degree in Life Sciences/Health/Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
Preferred: Degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing with hospital-based patient exposure.

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