Medical Writer I (Junior Project Specialist - 1 year Contract)
Medical Writer I (Junior Project Specialist - 1 year Contract)
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
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 deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
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.
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.
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
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 deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
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.
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.