Medical Writer Ii-narratives

2 weeks ago

Remote, India Syneos Health Clinical Full time

**Description**

**Medical Writer II**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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**
- 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 mínimal 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**

**What we’re looking for**
- 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.
- 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.

**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 exper

  • Medical Writer Ii

    5 hours ago

    Remote, India Parexel Full time

    Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and...

  • Medical Writer Ii

    7 days ago

    Remote, India Parexel Full time

    **Job Purpose**: - Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports,...

  • Medical Writer I

    1 week ago

    Remote, India Syneos Health Clinical Full time

    **Description** **Medical Writer I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...

  • Principal Medical Writer

    1 day ago

    Remote, India Thermo Fisher Scientific Full time

    The Publications and Scientific Communications team, a part of Medical Writing and Healthcare Communications at Evidera, prepares medical publications, abstracts, posters, presentations, and other scientific communications. Our dynamic, highly collaborative team focuses on providing quality writing to internal collaborators and external pharmaceutical and...

  • Principal Medical Writer

    3 days ago

    Remote, India Parexel Full time

    India, Remote **Job ID** R0000012940 **Category** Medical Writing **ABOUT THIS ROLE**: **Principal Medical Writer** **Minimum Qualification Requirements**: - 10+ years' experience in regulatory medical writing. Experience in authoring protocols, clinical study reports, investigator’s brochures, informed consent forms, summary documents, etc. -...

  • Senior Medical Writer

    Found in: beBee jobs IN - 1 day ago

    REMOTE, India Parexel Full time

    Job Purpose: Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United...

  • Medical Writer Intern

    6 hours ago

    Remote, India Gram Chikitsa Full time

    Medical Writer Intern - Health Blogging Location: Always Remote Duration: 6 Months Internship Education Requirement: Current Students Pursuing a Degree in Life Sciences (MBBS, BDS, BAMS, BHMS, B.Sc Nursing, B.Sc Zoology, B.Sc Botany, B.Sc Biotechnology, or other relevant life science fields) **Job Types**: Part-time, Fresher **Salary**: ₹6,000.00 per...

  • Senior Medical Writer

    Found in: beBee S IN - 1 week ago

    Remote, India Thermo Fisher Scientific Full time

    Job DescriptionProvides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Demonstrates subject matter and therapeutic area expertise. May assist program manager. Collaborates with internal and external clients, supporting and enabling effective and efficient...

  • Senior Medical Writer

    Found in: beBee jobs IN - 1 week ago

    Remote, India Thermo Fisher Scientific Full time

    Job DescriptionProvides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Demonstrates subject matter and therapeutic area expertise. May assist program manager. Collaborates with internal and external clients, supporting and enabling effective and efficient...

  • Medical Writer I

    7 days ago

    Remote, India Syneos Health Clinical Full time

    **Description** **Medical Writer I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...

  • Medical Writer I

    7 days ago

    Remote, India Parexel Full time

    **Job Purpose**: - Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports,...

  • Fiction Writer

    7 days ago

    Remote, India Pocket FM Full time

    **Responsibilities**: As the Creative Writer, you will be entrusted with the following key responsibilities: **Contribute in a writer’s room**: Work with the chief writer and fellow writers in a pod in crafting the written content for the YouTube adaptation of a Pocket FM audio series. **Scripting**: Ensure the creation of compelling scripts for the...

  • Freelance Pharma Content Writer

    1 week ago

    Remote, India Balaji Ventures Full time

    Content Writer - Pharma Industry Are you passionate about translating complex pharmaceutical concepts into engaging and informative content? We're seeking a skilled Content Writer with a background in the Pharma industry to join our dynamic team. **Responsibilities**: - Research, create, and edit high-quality content for various platforms, including...

  • Medical Content Writer

    3 days ago

    Remote, India Midiron Foods Full time

    **About Midiron Foods** We are a group of companies doing online selling of different products like Gifting, Home Decor, Festive, Food Products, etc. on different marketplaces like Amazon, Flipkart. For our Food division, we are seeking a talented and passionate Nutrition Content Writer to join our team. As a Nutrition Content Writer, you will be...

  • Medical Writer I

    1 day ago

    Remote, India Parexel Full time

    Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and...

  • Critical Review Writers

    7 days ago

    Remote, India Rehoboth Academic Services Full time

    **Job Summary** Rehoboth Academic Services specializes in academic writing, statistical analysis, copyediting and proofreading. We help PhD scholars across the globe by enriching their efforts in thesis writing, research papers, statistical analysis, etc. We are a ten year old organization based out of Bengaluru. We are looking for Scientific or Academic...

  • Entertainment Content Writer

    5 days ago

    Remote, India Zoof software Solutions Full time

    Job Description: We are seeking a talented and creative Content Writer to join our dynamic team at Zoof Software Solutions. As an Entertainment Content Writer, you will be responsible for producing high-quality, engaging content related to the entertainment industry, with a focus on Bollywood, Hollywood, box office collections, events, and other relevant...

  • Medical Data Reviewer

    1 day ago

    Remote, India ICON Full time

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What you will be doing**: Serve as a Clinical Data reviewer and identify any errors in data by...

  • Igaming Writer

    6 hours ago

    Remote, India North star network Full time

    North Star Network hosts sports fan communities across the world. We run sports media in over 40 countries, helping bettors make informed choices about their wagers and where to place them. A few figures about our portfolio of websites, which cover sports including football, boxing, MMA, e-sports, basketball and more: - 50+ websites in 9 languages - 50M+...

  • Academic Content Writer

    7 days ago

    Remote, India Contentmailes Full time

    Urgently we are looking an experienced Academic content writer. Has knowledge about all referencing style(Harvard, apa, Chicago etc.). Knowledge about management related topic(marketing, hrm, crm, hospitality, travel, medical, law, finance etc.). Company : Webstrummer Infolab Experience : minimum experience 6months to 1year. Freshers are not eligible for...