Senior Medical Writer – Principal, Regulatory Documents

🔥 0 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Lead clear and accurate completion of medical writing deliverables • Manage medical writing activities for individual studies and coordinate activities across departments • Lead resolution of client comments • Complete clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and scientific meeting presentations • Adhere to regulatory standards, company procedures, client standards, approved templates, authorship requirements, and style guides • Coordinate quality and editorial reviews • Manage source documentation appropriately • Lead team document reviews and act as a peer reviewer • Review statistical analysis plans and table/figure/listing specifications • Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams • Perform online clinical literature searches and comply with copyright requirements • Identify and propose solutions to issues, escalating as appropriate • Provide technical support, training, and consultation • Contribute to internal materials, presentations, processes, standard practices, and capabilities • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements • Monitor project budgets and communicate status and changes to medical writing leadership • Complete administrative tasks and perform other assigned duties

🎯 Requirements

• Experience and expertise in medical writing and regulatory documents • Ability to lead clear and accurate completion of medical writing deliverables • Ability to manage medical writing activities associated with individual studies with minimal supervision • Knowledge of regulatory standards, including ICH E3 guidelines • Ability to work with company/client standard operating procedures, templates, authorship requirements, and style and formatting guides • Ability to coordinate quality and editorial reviews • Ability to review statistical analysis plans and table/figure/listing specifications • Ability to interact with clients and cross-functional teams including data management, biostatistics, regulatory affairs, and medical affairs • Ability to perform online clinical literature searches and comply with copyright requirements • Ability to provide technical support, training, and consultation • Ability to mentor and lead less experienced medical writers on complex projects • Knowledge of industry topics and regulatory requirements and guidelines affecting medical writing • Ability to work within budgeted hours and complete administrative tasks within specified timeframes • Equivalent experience, skills, and/or education will also be considered • Minimal travel may be required (less than 25%)

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Opportunities for career paths and employment progression • Reasonable accommodations, when appropriate, for applicants and employees with disabilities