Medical Writer I (Project Specialist)

Medical Writer I (Project Specialist)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: 

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. 

Job Responsibilities

JOB TITLE: Medical Writer I (Project Specialist)

• Candidate with 1–2 years of experience in ETMF filing and Document management systems

• Should have experience in Filing documents based on: Versions, Metadata and Filing structure

• Should have experience of Veeva (Viva) RIM / Veeva Clinical and Good understanding of GxP guidelines.

• Candidate with excellent communication preferred

• Homebased opportunity with 12 PM to 9 PM Shift

JOB RESPONSIBILITIES

• Works within Veeva RIM, adapted to client requirements, to support accurate and compliant document filing.

• Performs eTMF filing activities, with an understanding of TMP filing, including key medical and regulatory components, while adhering to GxP guidelines (well-read and good understanding of GxP guidelines)

• - Manages document handling activities within Veeva, including downloading records from internal systems and uploading them into Veeva with accurate classification and storage

• - Ensures that all documents meet required quality and integrity standards before filing

• - Ensures tracking project documents and supports efficient access and keeps project data up to date

• - Maintains delivery timelines and ensures projects meet deadlines and milestones effectively

• - Categorizes documents systematically to streamline retrieval and organization processes

• - Ensures correct naming conventions, validating metadata, and placing documents in their appropriate locations within the Veeva system

• Understands the filing scope that includes but not limited to Early Access Programs and individual requests, External Research

• Projects, and Observational and Non-Interventional Studies

• Contributes to the creation and refinement of new processes, workflows, and SOPs, and adapt effectively to evolving operational requirements.

• Collaborates with client stakeholders and demonstrate a proactive, learning-oriented approach supported by strong communication skills, even without extensive project or stakeholder management experience.

• Showcases strong attention to detail and adherence to established filing guidelines to maintain compliance and system integrity.

• Demonstrates understanding of digital archiving practices and ensures electronic records are securely, systematically, and permanently preserved.

• Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.

• Participates in internal and client-facing meetings, as required, to liaise with client stakeholders and facilitate resolution of comments while ensuring alignment with stakeholder expectations and adherence to agreed timelines and submission deadlines.

• Monitors timelines for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk.

QUALIFICATION REQUIREMENTS

• Bachelor’s degree in the life sciences, clinical sciences with relevant scientific and/or medical knowledge and expertise; or copyediting, data integrity review, and/or relevant publishing experience.

• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).

• Exceptional attention to detail with strong organizational abilities and a service‑oriented mindset. Fluent in written, spoken, and reading English, with the capacity to multi‑task and perform effectively in high‑pressure environments. Proactive attitude and strong willingness to learn and contribute within a collaborative team setting.

• Excellent grammatical and communication skills, both written and oral.

• Ability to work with minimal supervision on multiple assignments with set deadlines.

• Ability to work independently as well as part of a team and keep others informed of the progress and status of projects.

• Adaptable to changes in work duties, responsibilities, and requirements.

• Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred.

Get to know Syneos Health

Over the past 5 years, we have 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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.