Medical Writer II (CSR Narrative)

5264 Syneos Health India Private Limited; Hyderabad; Hybrid; INR 900,000 - 1,300,000; Full time

Job summary

Syneos Health is seeking a Medical Writer II (CSR Narrative) to draft and edit CSR narratives and related medical writing deliverables. The role requires 2–4 years of medical writing experience and at least 1 year in narrative writing, with knowledge of ICH guidelines and FDA regulations. Collaborative and mentoring responsibilities are included.

The position involves writing, editing and reviewing clinical documents, staying within regulatory standards, and occasional travel (<25%).

Qualifications

• Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree with relevant scientific knowledge.
• Strong knowledge of English grammar and FDA and ICH regulations/guidelines.
• Demonstrated independence with proofreading, interpersonal and leadership skills.
• Proficiency in Word, Excel, PowerPoint, email and Internet.
• Ability to interpret and present clinical data and other complex information.

Responsibilities

• Mentors less experienced medical writers on projects.
• Compiles, writes, and edits medical writing deliverables with minimal supervision.
• Develops documents including clinical study protocols, reports and patient narratives.
• Reviews statistical analysis plans and specifications for content, grammar and formatting.
• Interacts with department heads to produce writing deliverables.
• Performs online literature searches and stays updated on regulatory guidance.

Skills

Medical writing

Narrative writing

Regulatory knowledge

Editing

Education

Bachelor of Science in related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Medical Writer II (CSR Narrative) 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

Min 2-4yrs of medical writing experience. Min 1 yr of narrative writing experience. Should be well versed with CSR Narrative writing ( Drafting and authoring )

JOB RESPONSIBILITIES

• 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 online 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%).

QUALIFICATION REQUIREMENTS

Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach. Strong proficiency in Word, Excel, PowerPoint, email, and Internet. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

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.

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.