Medical Writer II (CSR Narrative)

Syneos Health; India; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Syneos Health, Inc. is seeking a Medical Writer II (CSR Narrative) to lead narrative writing and related documentation for clinical programs. You will draft, edit, and review CSR narratives and related medical writing deliverables.

The role requires 2–4 years in medical writing and at least 1 year in narrative writing, with strong English grammar and regulatory knowledge. Expect collaboration across departments, adherence to ICH-E3, and occasional travel.

Qualifications

• Bachelor of Science degree with relevant writing experience or BA with relevant scientific/medical knowledge.
• Extensive knowledge of English grammar and FDA/ICH regulations and guidelines including AMA style guide.
• Independence with effective presentation, proofreading, interpersonal and leadership skills.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.

Responsibilities

• Mentor less experienced medical writers on projects as necessary.
• Compiles, writes, and edits medical writing deliverables with minimal supervision.
• Develops or supports documents including protocols, amendments, reports, patient narratives, annual reports and brochures.
• Reviews statistical analysis plans and ensures format, grammar, and consistency.
• Interacts with department heads and staff across data management, biostatistics, regulatory and medical affairs to produce writing deliverables.
• Serves as peer reviewer on internal review team; addresses comments to ensure scientific content and clarity.
• Adheres to ICH-E3 guidelines and SOPs, client standards, and approved templates, on-time and on-budget.
• Performs online literature searches and stays current with regulatory guidance in medical writing.
• Stays aware of budget specs and communicates changes to leadership.
• Completes administrated tasks within timeframes.
• Performs other duties; travel up to 25%.

Skills

Medical writing

Narrative writing

CSR narrative writing

Leadership

MS Word

Excel

PowerPoint

Communication

Education

Bachelor of Science

Bachelor of Arts (Social Sciences / English / Communications)

Tools

Word

Excel

PowerPoint

Email

Internet

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.

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.

Discover what your 25,000 future colleagues already know:

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 )

• 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%).

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