Description

The Medical Writer is responsible for developing clear, evidence-based materials by translating clinical and scientific data into accurate, compelling content. Working with internal teams, the role ensures strategic alignment, scientific rigor, and quality across publications and materials.

Key Skills Required:

• Scientific and clinical writing and expertise
• Literature searching & synthesis
• Quality control and proofreading
• Stakeholder and time management – ability to develop rapport with others and work in a team environment
• Familiarity with MS office and medical literature databases
• Compliance knowledge – familiarity with SOPs, audit requirements, and training standards within medical fields
• Advanced level of English; strong oral/written communication skills in English

Key Responsibilities:

• Research and Analysis – Gather and evaluate scientific literature to ensure the accuracy and relevance of information used in medical comms. Conduct literature searches using PubMed and other scientific databases, evaluating & validating references for accuracy/applicability.
• Content Development – Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately. Support the summarization and referencing of learning objectives to ensure clarity and alignment with educational goals.
• Clinical Study Protocol – Supports completion of clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures, NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
• Quality Assurance – Ensure the scientific accuracy and quality of all written materials and adherence to regulatory, internal, and client-direct standards/ specifications. Support MLR processes to ensure compliance and QA. Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.

Key Metrics to Monitor:

• Content Quality & Effectiveness - Quality score as per a pre-determined quality scorecard on writing deliverables.
• On-Time Delivery Rate – Deliverables submitted by agreed milestones.
• Feedback Scores – Quality feedback from senior medical writers or reviewers.

Additional Responsibilities:

• Off-the-shelf Training Management – Partner with teams to create and summarize inventories of existing assets. Assist in developing, updating and maintaining role-specific/ disease-specific training programs/curricula.
• Transcripts for e-Learning – Support preparation of transcripts for conversion into e-modules and other training modalities.
• Regulatory & Industry Compliance - Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
• Budget Management - Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.

Qualifications:

• BS + 8 yr experience; MSc/M. Pharm/PharmD + 4 yr experience; PhD + 1 yr experience
• 3-4 years of clinical research experience
• Working knowledge of Microsoft Office software (Word, Excel, and PowerPoint)
• Working knowledge of medical literature databases (e.g., Ovid, Medline, PubMed, etc.)

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Why Syneos Health? We partner with industry experts to solve and execute against today's toughest commercialization challenges facing the world's leading healthcare companies. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities on our Commercial Operations and Leadership teams. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world.

Work Here Matters Everywhere | How are you inspired to change lives?

Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled)

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.