Principal Medical Writer ( Regulatory Medical Writing docs)

Syneos Health; Hyderabad; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Syneos Health, Inc. is seeking a Principal Medical Writer to lead regulatory medical writing activities in a CRO setting from Hyderabad, India. The role focuses on authoring protocols, CSRs, PSURs, DSURs, ICFs, and IBs, and coordinating with pharma clients to deliver compliant documents on time.

The candidate will manage end-to-end documentation, mentor junior writers, and ensure adherence to ICH guidelines and client templates across multiple studies.

Qualifications

• 5+ years of Regulatory Medical Writing experience with expertise in authoring protocols, amendments, CSRs, narratives, PSURs, DSURs, ICFs, and IBs.
• Experience as Lead Medical Writer, independently managing end-to-end document development in a CRO environment.
• Ability to manage multiple deliverables, coordinate with cross-functional teams and meet client expectations.

Responsibilities

• Leads the clear and accurate completion of complex medical writing deliverables.
• Manages medical writing activities across studies with minimal supervision.
• Coordinates reviews and ensures quality and regulatory compliance.
• Mentors junior writers and supports development of internal standards.

Skills

Regulatory medical writing

Lead medical writer

Protocols and CSRs

DSURs/PSURs/IBs/ICFs

Job description

Principal Medical Writer ( Regulatory Medical Writing docs)Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.Discover what your 25,000 future colleagues already know:Why Syneos Health• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.Job Responsibilities5+ years of Regulatory Medical Writing experience with expertise in authoring Protocols, Protocol Amendments, CSRs, Narratives, PSURs, DSURs, ICFs, and IBs.Proven Lead Medical Writer experience, independently managing end-to-end document development in a CRO environment while partnering with pharmaceutical companies.• Leads the clear and accurate completion of complex medical writing deliverables, ensuringscientific information is presented clearly and accurately. Manages medical writing activitiesassociated with individual studies, defining document strategy and coordinating medical writingactivities within and across departments with minimal supervision. Leads the resolution ofcomments from the client.• Completes a variety of documents that may include clinical study protocols and clinical studyprotocol amendments; clinical study reports; patient narratives; annual reports; investigatorbrochures; informed consents; annual reports; plain language summaries; periodic safety updatereports, clinical development plans; IND submissions; integrated summary reports; NDA andeCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientificmeetings.• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, aswell as company standard operating procedures, client standards, and company and/or clientapproved-templates, authorship requirements, and style and formatting guides, when completingmedical writing projects, on time and on budget.• Advises clients and study teams on data presentation and production strategies to ensure thatclient objectives/expectations are met and quality standards are maintained.• Leads team document reviews and reviews documents for technical issues. Coordinates qualityand editorial reviews and ensures source documentation is managed appropriately.• Serves as expert peer reviewer for internal team, providing review comments to give maximumclarity of meaning, accuracy, and relevance, and to ensure that client objectives are met andoverall quality standards are maintained.• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content,and for grammar, format, and consistency. Provides feedback to further define statistical outputrequired and document needs.• Interacts and builds good working relationships with clients, department head, and team membersin data management, biostatistics, regulatory affairs, and medical affairs, as necessary, toproduce writing deliverables. Works with staff across company to advance company priorities.• Performs online clinical literature searches and complies with copyright requirements.• Identifies and proposes solutions to resolve issues, escalating as appropriate. Serves as a keytechnical SME and contributes to development of internal materials and presentations on neededtopics. Contributes to changes to internal process, standard practices, and capabilities.• Mentors and leads less experienced medical writers on complex documents.• Develops deep expertise on key topics in the industry and the regulatory requirements andguidelines that affect medical writing. Engages externally with industry groups on industryinitiatives.• Aware of budget specifications for assigned projects, communicating status and changes tomedical writing leadership. Contributes to bid projections.• Communicates status and changes to medical writing leadership; negotiates timelines andassigned deliverables.• Represents the medical writing department on clinical study teams, at conferences, meetings, andfor presentations to the client regarding writing projects.• Completes required administrative tasks within the specified timeframes.• Performs other work-related duties as assigned.• Minimal travel may be required (less than 25%).Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.http://www.syneoshealth.comAdditional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.