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Single Sponsor Principal/Sr Medical Writer - Spain, Poland, Ireland, Netherlands, France, Uk, Switzerland, Belgium, Italy, Us And Canada. Must Have Lead Submissions Experience.

0-2 years
Not Disclosed
10 Dec. 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science/BA 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 Medical Writer
Company: Syneos Health®


About Syneos Health
Syneos Health is a leading integrated biopharmaceutical solutions organization, dedicated to accelerating customer success by turning clinical, medical, and commercial insights into impactful outcomes. Our Clinical Development model centers on both the customer and patient, striving for simplicity, efficiency, and impact in everything we do.

Whether you join us in a Functional Service Provider or Full-Service capacity, you'll work alongside passionate, innovative teams committed to accelerating the delivery of therapies and changing lives.


Why Syneos Health?

  • Career Development: We focus on developing our people through career growth opportunities, technical and therapeutic training, and mentoring.
  • Inclusive Environment: We promote a Total Self culture, where everyone can bring their authentic selves to work, fostering inclusivity and belonging.
  • Global Impact: With 29,000 employees across 110 countries, we work together to make a difference in patient lives.

Key Responsibilities:

  • Project Leadership: Mentor and lead less experienced writers on complex projects. Act as the lead on assigned writing projects and submissions.
  • Document Creation: Develop and support the creation of various documents, including but not limited to:
    • Clinical study protocols and amendments
    • Clinical study reports
    • Patient narratives
    • Clinical development plans
    • IND submissions and annual reports
    • Integrated summary reports and NDA/eCTD submissions
    • Investigator brochures
    • Clinical journal manuscripts and abstracts
    • Client presentations
  • Problem Solving: Identify and resolve issues that arise during the writing process, escalating as necessary.
  • Document Review: Review statistical analysis plans, tables, figures, and listing specifications for accuracy, grammar, and consistency.
  • Cross-Department Collaboration: Interact with departments such as data management, biostatistics, regulatory affairs, and medical affairs to produce high-quality writing deliverables.
  • Peer Review: Serve as a peer reviewer, providing feedback on draft and final documents.
  • Regulatory Compliance: Adhere to ICH-E3 guidelines, SOPs, client standards, and approved templates to ensure projects are completed on time and within budget.
  • Clinical Literature Searches: Perform literature searches as required to support writing tasks.
  • Industry Knowledge: Stay up-to-date with industry practices and regulatory guidelines impacting medical writing.
  • Budget Management: Ensure projects remain within budgeted hours and communicate any changes to leadership.

Qualifications:

  • Education: Bachelor of Science (or equivalent) with relevant writing experience, or a Bachelor of Arts (Social Sciences, English, or Communications) with scientific and/or medical knowledge.
  • Experience: Extensive experience in a Senior/Principal Clinical Writing role within a CRO or pharmaceutical company, specifically leading submissions processes.
  • Skills:
    • Strong proficiency in English grammar and familiarity with FDA and ICH regulations, AMA style guide, and clinical writing standards.
    • Ability to interpret and present complex clinical data.
    • High degree of independence, effective presentation skills, proofreading expertise, and leadership abilities.
    • Proficient in Word, Excel, PowerPoint, email, and internet applications.

Compensation and Benefits:

  • Competitive salary and benefits package
  • Opportunity for career development and leadership growth within a global organization

Additional Information:

  • Tasks and responsibilities may be adjusted as needed, based on project needs and organizational changes.
  • Syneos Health is committed to equal opportunity and compliance with all regulations, including the Americans with Disabilities Act.

Join Syneos Health today to be part of a team that’s shaping the future of healthcare and making a lasting impact on patient lives!