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Syneos Health
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Medical Writer I

Medical Writer I

Syneos Health

1 - 4 years

3 - 6 Lacs

gurugram

Posted:21 hours ago| Platform:

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Skills Required

biometrics career development data management agile clinical development clinical research http medical writing recruitment clinical data

Work Mode

Work from Office

Job Type

Full Time

Job Description

Medical Writer I

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. WhyBecause 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 Description

JOB TITLE: Medical Writer I

SELECT ONE: Clinical Solutions

JOB CODE: 00098

JOB FAMILY: Biometrics

BUSINESS UNIT

(COMMERCIAL ONLY):

REPORTS TO: Manager, Medical Writing; or designee

JOB SUMMARY Serves as medical writer on clinical study or regulatory project teams. Assists in writing, editing, and coordinating content for clinical/regulatory documents with dependent staff roles to ensure satisfactory completion of all writing projects.

JOB RESPONSIBILITIES

Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate 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;
Investigator brochures.

Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency. Provides feedback to further define statistical output required.
Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
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.
Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
Is 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 with a familiarity with AMA style guide.
Understanding of FDA and ICH regulations and guidelines strongly preferred.
Demonstrated effective presentation, proofreading, and interpersonal, 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.

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