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Medical Writer Ii

1-3 years
Not Disclosed
10 Sept. 10, 2025
Job Description
Job Type: Remote Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences 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: Medical Writer II

Location: [Not specified]
Company: Syneos Health®


About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We combine clinical, medical affairs, and commercial insights to deliver outcomes that meet modern market needs.

  • Global Reach: 29,000 employees across 110 countries

  • Mission: Bringing customers and patients to the center of everything we do

  • Culture: Agile, collaborative, inclusive, and driven to change lives

  • Work Philosophy: Work Here Matters Everywhere


Why Join Us

  • Career development and progression opportunities

  • Supportive leadership and engaged line management

  • Technical and therapeutic area training

  • Recognition programs and total rewards

  • Total Self Culture: A diverse and inclusive workplace where authenticity is valued


Job Responsibilities

Core Responsibilities

  • Lead the clear, accurate, and timely completion of medical writing deliverables

  • Ensure scientific information is presented clearly and in compliance with regulatory standards (ICH E3, FDA, client templates, AMA style)

  • Manage medical writing activities for individual studies with minimal supervision

  • Collaborate across departments (data management, biostatistics, regulatory, medical affairs)

Key Deliverables

Prepare, write, and review a wide range of documents, including:

  • Clinical study protocols, amendments, and reports

  • Patient narratives, annual reports, investigator brochures

  • Informed consents and plain language summaries

  • Periodic safety update reports (PSURs)

  • Clinical development plans, IND submissions, NDA/eCTD submissions

  • Integrated summary reports, journal manuscripts, posters, and abstracts

Additional Duties

  • Conduct clinical literature searches and ensure copyright compliance

  • Review statistical analysis plans and output for accuracy, grammar, and clarity

  • Perform peer review for internal teams to ensure quality and consistency

  • Mentor and guide less experienced medical writers

  • Provide technical support, training, and consultation across teams

  • Work within assigned project budgets


Required Qualifications

  • Bachelor’s degree in a relevant discipline (advanced degree preferred)

  • 1–3 years of experience in clinical trial disclosure (mandatory)

  • Hands-on experience with clinical registries: CT.gov, CTIS, EUDRACT

  • Experience in disclosure and redaction activities

  • Prior client interaction experience


Necessary Skills

  • Strong knowledge of FDA, ICH regulations, and good publication practices

  • Proficiency in medical terminology and ability to interpret clinical data

  • Excellent English grammar and written communication skills

  • Familiarity with AMA Manual of Style

  • Proficiency in MS Office Suite

  • Strong project management, time management, and presentation skills

  • Excellent collaboration, proofreading, and interpersonal skills


Preferred Attributes

  • Ability to build strong client and cross-functional relationships

  • Proactive problem-solving and issue resolution skills

  • Capacity to lead complex projects independently

  • Willingness to continuously develop expertise in industry and regulatory requirements


Additional Information

  • Job tasks and responsibilities may evolve at the company’s discretion

  • Equivalent skills/experience will be considered in place of formal qualifications

  • Syneos Health complies with all applicable employment legislation, including ADA reasonable accommodations and EU Equality Directive requirements


About Our Impact

  • Worked with 94% of all Novel FDA Approved Drugs in the past 5 years

  • Supported 95% of EMA Authorized Products

  • Partnered on 200+ studies across 73,000 sites and 675,000+ patients


🔗 Learn more: www.syneoshealth.com