Consultant I, Medical Writing Job at Syner-G BioPharma Group in San Diego

Job OverviewSyner-G enables teams to build careers that have a positive impact on quality of life through expertise in science, consulting, and product development across the entire drug discovery and approval lifecycle. We serve diverse clients, accelerating breakthrough therapies to patients through strategic, solutions-driven work from science to delivery.This role is for an MWS Consultant I who author, manage and oversee regulatory documents, support client regulatory strategies, and ensure high-quality deliverables that meet client expectations and regulatory standards.Key ResponsibilitiesAuthor regulatory documents such as Clinical Study Reports (CSR), study protocols and client submission materials.Lead development of complex modules (e.g., Module 2 summaries, Briefing Documents, Orphan Drug, Fast-Track, and Breakthrough Designation applications).Apply quality control and submission-readiness processes to deliver high-quality documents within client timelines.Act as project owner: track timelines, adjust schedules, and coordinate with clients to address evolving demands.Plan for project challenges, update visual timelines, and maintain adherence to deadlines.Facilitate client interactions, including meetings, inquiries and feedback, building and maintaining trust.Ensure consistency, accuracy and alignment across documents with client updates and applicable regulatory standards.Collaborate with cross-functional teams to ensure quality and accuracy of regulatory documents.Contribute to development of regulatory strategies for early-stage and smaller clients.Provide guidance on tools, document management systems and client SOPs.Engage in continuous learning through exposure to new document types, processes and industry best practices under senior mentorship.Qualifications and RequirementsAdvanced degree in life or health science (M.S., PharmD, Ph.D., or M.D.) preferred.RAC certification beneficial.3+ years industry experience.Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Teams and MS Project.Familiarity with regulatory document management systems such as Veeva Vault.Experience with regulatory submissions and understanding of global regulatory standards.Strong foundation in medical writing, regulatory writing and interpretation of scientific content.Knowledge of pharmaceutical and biopharmaceutical environments, including clinical trials and regulatory submissions.Excellent written and verbal communication skills for conveying complex scientific and regulatory information clearly.Exceptional project and time management skills with ability to prioritize multiple projects and adjust timelines proactively.Patient and empathetic approach in cross-cultural and client-facing environments.Positive attitude toward feedback and continuous improvement.Strong critical thinking and data analysis skills to ensure scientific claims align with evidence and regulatory requirements.High attention to detail for accuracy across document reviews.Essential Functions & Physical DemandsRegular use of computer keyboard and mouse; reach with hands and arms; talk and listen. Frequently required to walk and sit, and to lift and carry objects such as books and files up to 25 pounds. Occasionally required to stand, stoop, or kneel. Vision required: close vision and ability to adjust focus. Work environment typical for an office: moderate noise level, indoor temperate environment, light levels bright and conducive to minimal eye strain.Compensation & BenefitsCompetitive base salary and annual incentive plan. Robust benefit offerings. Generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote or hybrid options for eligible roles. Physical work location options include Greater Boston, San Diego, CA, Boulder, CO and India. Technical Operations team may work at physical client sites.Legal StatementSyner-G is proud to be an Equal Employment Opportunity and affirmative action employer. All employment decisions, including recruiting, hiring, placement, training, promotion, compensation, evaluation and termination are made without regard to race, color, creed, religion, sex, pregnancy, sexual orientation, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, age, marital status, military status, disability or any other basis prohibited by applicable law. Syner-G is an E-Verify employer.J-18808-Ljbffr