Principal Medical Writer

3 weeks ago

Gurgaon, India Syneos Health Clinical Full time

**Description**

**Principal Medical Writer**

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 SUMMARY**:
**Provides scientific writing, regulatory guidance and technical expertise in the writing, production, and review of high quality Lay Summaries (LS), regulatory and other scientific/clinical documents ensuring that clinical data is presented in documents in compliance with applicable regulatory guidelines.**:
**Skills Requirements**:

- Minimum 8 years of regulatory writing experience.
- Experience in writing patient facing documents such as Informed Consent form (ICF), patient information Leaflets (PIL), or safety reports (DSURs, PSURs) with exposure to PLS writing preferred.
- Excellent in English Verbal/ Writing skills.

**JOB RESPONSIBILITIES**:

- Serves as peer reviewer and mentor for junior LS writers, providing review comments to give maximum clarity of meaning, accuracy relevance and to ensure that client objectives are met and overall quality standards are maintained.
- Reviews source documents for appropriateness in terms of data presentation and compliance with mínimal regulatory disclosure requirements.
- Leads patient or lay review panels to collate feedback on LSs and relay findings back to the Sponsor.
- Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding writing projects.
- Advises clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.
- Develops good working relationships with internal and external colleagues.
- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with mínimal supervision.
- Mentors and leads less experienced medical writers on complex LS projects, as necessary.
- Develops or supports a variety of documents that include but not limited to:

- Clinical study protocols and clinical protocol amendments;
- Clinical study reports;
- Patient narratives;
- Clinical development plans;
- IND submissions and annual reports;
- Integrated summary reports;
- NDA and (e)CTD submissions;
- Investigator brochures;
- Clinical journal manuscripts, including plain language summary of publications, clinical journal abstracts, and client presentations.
- Adheres to established regulatory standards, including but not limited to ICH guidelines, as well as company SOPs, 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.
- Understands 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 exper

  • Medical Content Writer

    1 month ago

    Gurgaon, India SGT University Full time

    VACANCY FOR MEDICAL CONTENT WRITER **SGT University (NAAC A+ Grade Accredited), **in its campus spread over 70 acres near Gurgaon, offers around 160+ programs in Medical and Non-Medical domains. It nurtures more than seven thousand students and is a hub of activities involving the nation’s who’s who. It is a part of a group spanning the fields of...

  • Medical Writer Ii

    4 weeks ago

    Gurgaon, 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...

  • Medical Content Writer

    1 month ago

    Gurgaon, India Edha Care Full time

    **Hi,** **Quick Facts for US4 Group**: Global Locations: Dubai (UAE), Florida (US) and Gurgaon (India) Headcount: 200+ employees Turnover: USD 10 Million **Designation: - Content Writer** Location: - Gurugram **Key Roles & Responsibilities: -** - Implement SEO best practices to drive organic traffic to the brand - Stay up-to-date on latest content...

  • Medical Writers

    1 month ago

    Gurgaon, India medONE Pharma Solutions India Full time

    Work from Home - Preparing and editing of medical and scientific manuscripts, and abstracts. - Production and publication of peer-reviewed scientific papers and presentations explaining the results of clinical studies. - Good Communication Skills. - Thorough understanding of editing and regulatory processes and requirements. **Job Code**: MIS-MW.

  • Scientific Content Writer

    1 month ago

    Gurgaon, India SGT University Full time

    VACANCY FOR SCIENTIFIC CONTENT WRITER **SGT University (NAAC A+ Grade Accredited), **with its campus spread over 70 acres near Gurgaon, offers around 160+ programs in Medical and Non-Medical domains. It nurtures more than seven thousand students and is a hub of activities involving the nation’s who’s who. It is a part of a group spanning the fields of...

  • Medical Writer Ii

    4 weeks ago

    Gurgaon, India Syneos Health Clinical Full time

    **Description** **Medical Writer II/Sr Medical Editor** 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...

  • Medical Writer I(Clinical Trial Transparency)

    1 month ago

    Gurgaon, 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...

  • Manager Scientific Medical Affairs

    2 days ago

    Gurgaon, Haryana, India Abbott Laboratories Full time

    Its a Multi Country RoleTo competently manage the Medical and scientific affairs Department in IndiaCollaborate with the commercial team and build medical strategy for India. Assist and advise Marketing on all promotional activities, and to ensure compliance with the relevant promotional Codes.As a member of by the Medical Affairs department, ensure...

  • Content Writer

    1 month ago

    Gurgaon, India Digeesell Full time

    **What we do**: Professionally innovative, Digitally creative - Digeesell is committed to create, rejuvenate and reposition brands at their best. We delightfully open the doors of the digital world for new businesses and help existing businesses to bloom and excel. **Culture and Benefits**: Our Digee - experts are an asset to us and so we make sure to...

  • Content Writer

    1 month ago

    Gurgaon District, Haryana, India Digeesell Full time

    **What we do**: Professionally innovative, Digitally creative - Digeesell is committed to create, rejuvenate and reposition brands at their best. We delightfully open the doors of the digital world for new businesses and help existing businesses to bloom and excel. **Culture and Benefits**: Our Digee - experts are an asset to us and so we make sure to...

  • Principal, Research

    1 month ago

    Gurgaon, India Gartner Full time

    **Description**: Title: Principal, Research About the role: Are you intellectually curious and motivated by ideas? Do you want to create research products that are widely used by executive leaders worldwide? Gartner is searching for a Gurgaon-based Principal Research to join our global research team. This opportunity will give you exposure to a range of...

  • Technical Writer

    3 weeks ago

    Gurgaon/Gurugram, India Logicladder Technologies Full time

    Job Description : As a Technical Writer with expertise in API and coding documentation, you will be translating complex technical information into clear, concise, and user-friendly documentation. This role involves collaborating with cross-functional teams, including developers, product managers, and quality assurance, to create documentation that enhances...

  • Customer Relationship Executive

    1 month ago

    Gurgaon, India SCIENCE OLYMPIAD FOUNDATION Full time

    **JOB DESCRIPTION** - Excellent Communication Skills both verbal and written in English. - Flexibility to adapt to a fast-paced learning atmosphere. - The job would include handling of Data Processing and coordination / Follow-ups with School Principal/Teachers **SKILLS & REQUIREMENT** - An interest in computers and Internet technology. - Unconditional...

  • Head of Content

    4 weeks ago

    Gurgaon, India Khan Academy Full time

    ABOUT THE ROLEWe’re looking for an enthusiastic, dynamic leader to propel our short- and long-term strategic vision of Khan India’s math and science offerings. Then, we translate that vision into concrete definitions of content success, precise project plans, and efficient processes. In this role, you’ll also be a people manager responsible for...

  • Head of Content

    1 month ago

    Gurgaon, India Khan Academy Full time

    ABOUT THE ROLE We’re looking for an enthusiastic, dynamic leader to propel our short- and long-term strategic vision of Khan India’s math and science offerings. Then, we translate that vision into concrete definitions of content success, precise project plans, and efficient processes. In this role, you’ll also be a people manager responsible for...

  • Head of Content

    1 month ago

    gurgaon, India Khan Academy Full time

    ABOUT THE ROLE We’re looking for an enthusiastic, dynamic leader to propel our short- and long-term strategic vision of Khan India’s math and science offerings. Then, we translate that vision into concrete definitions of content success, precise project plans, and efficient processes. In this role, you’ll also be a people manager responsible...

  • Athena Education

    3 weeks ago

    Gurgaon/Gurugram, India Athena Education Full time

    Principal Software Development Engineer at Athena Education (View all jobs)Gurugram, Haryana, IndiaWho we are: Athena is India's largest institution in the "premium undergraduate study abroad" space. Founded 10 years ago by two Princeton graduates, Poshak Agrawal and Rahul Subramaniam, Athena is headquartered in Gurgaon, with offices in Mumbai and...

  • Sales Co-ordinator

    1 month ago

    Gurgaon, India Nest Corner Healthcare Solutions Pvt Ltd. Full time

    **Job Descriptions**: - JOB TITLE: Coordinator & Inside Sales DEPARTMENT: Back Office REPORTING: Operation Head JOB LOCATION: Gurgaon RESPONSIBILITIES: 1. Coordination of Sales a. Key account management. b. Regular communication with key customers and maintaining cordial relations. c. Managing vendors and principal companies. d. End-to-end order and supply...

  • Java Developer

    2 weeks ago

    gurgaon, India Intellect Design Arena Ltd Full time

    We are looking to hire a seasoned Executive Assistant for Gurgaon location, Ideal candidate will have minimum 3+ years of experiencePOSITION: Java DeveloperEXPERIENCE (IN YEARS): 2 to 5ROLE TYPE: Full timeLOCATION: GurgaonABOUT INTELLECT DESIGN ARENA LTD.Intellect Design Arena Limited is a global leader in Financial Technology for Banking, Insurance and...