Medical Writer II (Clinical Trial Transparency)

5264 Syneos Health India Private Limited; India; Remote; INR 1,200,000 - 2,200,000; Full time

Job summary

Syneos Health in India seeks a Medical Writer II (Clinical Trial Transparency) to contribute to disclosure documents, clinical study protocols, and trial reports. You will work with cross-functional teams to ensure accuracy, clarity, and regulatory compliance across global standards.

The role requires experience in clinical trial disclosure, FDA/ICH guidelines familiarity, and strong command of English grammar and AMA style, with proficiency in MS Office and solid communication skills.

Qualifications

• Bachelor's degree with relevant writing experience; graduate degree preferred.
• Strong understanding of FDA/ICH regulations and other regulatory guidelines.
• Experience writing regulatory documents and disclosure deliverables.
• Excellent English grammar and AMA Manual of Style familiarity.

Responsibilities

• Collaborates to produce medical writing deliverables with minimal supervision.
• Develops protocols, protocol amendments, study reports, patient narratives and annual reports.
• Reviews statistical analysis plans, tables, figures for content, grammar and formatting.
• Ensures adherence to regulatory standards and client templates; on-time and on-budget.

Skills

Medical writing

Regulatory knowledge

Editing

Communication

Education

Bachelor's degree

Graduate degree preferred

Tools

MS Office

MS Word

Job description

Medical Writer II (Clinical Trial Transparency)

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

• 1 to 3 years of experience in Disclosure.
• Knowledge of Clinical Research, Clinical Trial, clinical registries (CT.gov, CTIS- Clinical Trial information System, EUDRACT).
• Experience in clinical registries, clinical trial Disclosure is mandatory.
• Experience in databases like Pharma CM/ Disclose.
• Good understanding of protocol registration process.
• Fine with candidate with combination of redaction Disclosure.
• Mentors less experienced medical writers on projects, as necessary.
• Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision.
• Develops or supports a variety of documents that include but not limited to:
• Clinical study protocols and clinical study protocol amendments.
• Clinical study reports.
• Patient narratives.
• Annual reports.
• Investigator brochures.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
• Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Serves as peer reviewer on internal review team.
• Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.
• Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
• Performs on-line clinical literature searches, as applicable.
• Working knowledge of drug development process and regulatory guidelines.
• Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing.
• Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
• Completes required administrated tasks within the specified timeframes.
• Performs other work-related duties as assigned.
• Minimal travel may be required (less than 25%).

Qualifications

• Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred.
• Client interaction experience.
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required.
• Experience writing relevant document types required.
• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style.

Necessary Skills

• Strong presentation, proofreading, collaborative, and interpersonal skills.
• Strong project and time management skills.
• Strong proficiency in MS Office.
• Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information.

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.

Learn more about Syneos Health. http://www.syneoshealth.com

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.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.