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Sr Medical Writer

0-2 years
Not Disclosed
10 May 2, 2025
Job Description
Job Type: Remote 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

 

Job Title: Senior Medical Writer

Location: Home-Based, Mexico
Job ID: 24003298-MEX975


Company Overview

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by transforming clinical, medical affairs, and commercial insights into outcomes. We focus on addressing modern market realities and placing the customer and patient at the center of everything we do.

At Syneos Health, we continuously strive to simplify our work processes to make the experience easier both for our customers and employees. We are agile, driven by innovation, and dedicated to accelerating the delivery of therapies that change lives.

Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE


Why Syneos Health

  • Career Development: We are passionate about developing our people through career progression, technical and therapeutic training, and recognition.

  • Inclusive Culture: Our Total Self culture allows you to be authentically yourself, ensuring an environment where everyone belongs.

  • Diversity of Thought: We believe in bringing together diverse perspectives to create a supportive, inclusive workplace.


Job Responsibilities

  • Mentorship: Guide and mentor less experienced medical writers on complex writing projects.

  • Project Leadership: Lead assigned writing projects and coordinate medical writing activities across departments with minimal supervision.

  • Document Creation: Develop and support the creation of various documents, including:

    • Clinical study protocols and amendments

    • Clinical study reports

    • Patient narratives, clinical development plans

    • IND submissions, annual reports, NDA submissions

    • Investigator brochures, clinical journal manuscripts, client presentations

  • Issue Resolution: Identify and propose solutions for challenges that arise during the writing process.

  • Review Process: Review statistical analysis plans, tables, and figures for grammar, consistency, and correctness.

  • Collaboration: Interact with cross-functional teams in data management, biostatistics, regulatory affairs, and medical affairs to ensure accurate deliverables.

  • Regulatory Compliance: Adhere to ICH-E3 guidelines and SOPs while completing writing projects on time and on budget.

  • Literature Search: Perform online clinical literature searches as necessary.

  • Budget Management: Work within project budgets and communicate any changes to medical writing leadership.


Qualifications

  • Education: Bachelor of Science or Arts degree (preferably in Social Sciences, English, or Communications) with relevant scientific/medical knowledge.

  • Experience: Extensive medical writing experience, with in-depth knowledge of FDA and ICH regulations and the AMA style guide.

  • Skills:

    • High proficiency in Word, Excel, PowerPoint, email, and internet.

    • Strong leadership, proofreading, interpersonal, and presentation skills.

    • Ability to interpret and present complex clinical research data.


Additional Information

  • Travel: Minimal travel (less than 25%).

  • Flexibility: Tasks and responsibilities may be assigned as needed by the company.

  • Equal Opportunity: Syneos Health is committed to compliance with ADA and Equal Opportunity laws.


Impact & Achievements

Syneos Health has 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 over the past five years.