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Mgr, Medical Writing (Process Map)

0-2 years
Not Disclosed
10 Jan. 31, 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

πŸ“Œ Manager, Medical Writing | Syneos Health
πŸ“ Location: Gurugram, DLF Downtown (India-Asia Pacific)
πŸš€ Leading Biopharmaceutical Solutions Organization

🌟 About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success through clinical, medical affairs, and commercial insights. We bring the customer and patient to the center of everything we do, focusing on continuous improvement and innovation to make us both easier to work with and for.

πŸ“ About the Role

As the Manager, Medical Writing, you'll be responsible for managing the medical writing staff and overseeing the quality and accuracy of deliverables. You'll help manage budgets, timelines, and resources for medical writing activities while ensuring high-quality standards and compliance with regulations. Your role also involves business development, leadership of cross-functional teams, and supporting the company's growth and objectives.

πŸ” Key Responsibilities

Project & Staff Management

βœ” Staff Management: Supervise medical writing team, assist with performance appraisals, and provide guidance on technical issues and priorities.
βœ” Quality Oversight: Review and edit work products for quality, ensuring alignment with Sponsor objectives.
βœ” Budgeting & Forecasting: Assist with the preparation of budgets, timelines, and forecasting for medical writing activities.
βœ” Cross-Functional Leadership: Lead and maintain productive cross-functional teams, managing internal and external relationships.

Business Development & Metrics

βœ” Proposal Support: Assist in proposal development, costing, and customer meetings.
βœ” Metrics & Reporting: Contribute to departmental metrics, tracking project progress, and identifying areas for improvement.

Document Development & Review

βœ” SOP Development: Develop and maintain SOPs and templates for the department.
βœ” Senior Reviews: Perform senior-level reviews of medical writing deliverables, statistical analysis plans, and other related documents.

πŸ“‹ Qualifications

πŸŽ“ Bachelor’s degree with relevant scientific or medical expertise.
πŸ“Œ Experience: Strong background in medical writing with management experience in a pharmaceutical, CRO, or medical device company.
πŸ“Œ Knowledge: In-depth knowledge of clinical research principles, FDA, EU, ICH regulations, and ISO standards.
πŸ“Œ Skills: Excellent English grammar, communication, leadership, and Microsoft Office Suite skills.
πŸ“Œ Management Experience: Preferred experience in leading teams and managing staff performance.

🌍 Why Syneos Health?

🌟 Career Development: Focus on progression, technical training, and peer recognition.
🌍 Diversity & Inclusion: We embrace diversity of thoughts, cultures, and perspectives.
πŸ’Ό Impact: Contribute to advancing 94% of FDA-approved drugs in the past five years.

πŸ“© Apply Now