Talent.com
This job offer is not available in your country.
Senior Clinical Evaluation Medical Writer

Senior Clinical Evaluation Medical Writer

MEDTRONICINDIA
30+ days ago
Job description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

The Clinical Evaluation Medical Writer on our Endoscopy Clinical Evaluation team provides technical, regulatory and strategic medical writing expertise for the development of initial and updates of clinical evaluation documents (e.g., CEP, CER, PMCFP, PMCFR and SSCP) throughout the product development and lifecycle. Experience in medical or scientific writing, critical literature review and data analysis, and / or quality engineering / risk management and strong written and verbal communication skills are needed.

The medical writer combines understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with the MEDDEV 2.7 / 1 Rev 4 and EU Regulation 2017 / 745. The medical writer will interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety, performance, adverse events and risk / benefit profile of a device or devices. Moreover, the writer may be requested to contribute to other activities such as drafting of clinical summaries of literature articles and interacting with regulatory agencies representatives as needed.

Responsibilities may include the following and other duties may be assigned :

  • Independently creates and maintains Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Clinical Follow Up Plans (PMCFP), Post Market Clinical Follow Up Reports (PMCFR) and Summary of Safety and Clinical Performance [SSCP] for medical devices in accordance with MEDDEV 2.7 / 1 Rev 4, MDD, EU MDR 2017 / 745, MDCG guidance documents and applicable Medtronic procedures and templates.
  • Identifies, evaluates, appraises, analyzes, summarizes and synthesizes clinical evidence including data from sources such as preclinical studies, clinical investigations, literature, and other post-market surveillance sources. Analyzes results in preparation for product applications and submissions.
  • Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence. Review and summarize scientific literature (e.g. screens articles against inclusion / exclusion criteria, analyzes and appraises the quality, suitability and relevance of the included studies, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports).
  • Reports instances of complaints / adverse events from literature to GCH.
  • Create responses for audit / submission queries.
  • Maintains database of peer-reviewed literature.
  • Develop state of the art on product family for its intended purpose.
  • Review / approve other documentation for device development.
  • Reviews IFUs, Risk Management files and other cross-functional documents to ensure alignment of risk information.
  • Knowledge of regulatory agencies guidelines on clinical evaluation requirements.
  • Clearly and timely communicates timelines, required inputs for projects, project risks, etc. with cross-functional stakeholders.

Required Knowledge and Experience :

  • Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
  • May have broad knowledge of project management.
  • Requires a Baccalaureate degree and total 8 years of experience with minimum 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.
  • Physical Job Requirements

    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

    Benefits & Compensation

    Medtronic offers a competitive Salary and flexible Benefits Package

    A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

    This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

    About Medtronic

    We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

    Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000 passionate people.

    We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

    Learn more about our business, mission, and our commitment to diversity here .

    Locations - IND-TS Hyderabad Nanakramguda, India

    Create a job alert for this search

    Senior Medical Writer • INDIA

    Related jobs
    Medical Writer

    Medical Writer

    Tata Consultancy ServicesIndia
    Medical Writer!!! Job Location –.Mumbai / Pune / Bangalore Experience Range –.Years Educational Qualification(s) Required –. Setting, discussing and meeting expectations of the document during kick off ...Show moreLast updated: 26 days ago
    • Promoted
    Medical Writer

    Medical Writer

    RRD GO CreativeChennai, Tamil Nadu, India
    In this role you will be responsible for : .Developing high-quality, scientifically accurate medical and regulatory documents, including clinical study reports, protocols, brochures, and more.Creatin...Show moreLast updated: 24 days ago
    Medical Writer

    Medical Writer

    Starfish HiringIN
    Remote
    Quick Apply
    A leading global pharmaceutical brand is seeking an experienced .The ideal candidate will have strong medical writing experience, particularly in consensus development within the APAC region, ...Show moreLast updated: 30+ days ago
    Medical Writer

    Medical Writer

    Sri Sai Overseas RecruitmentVadodara, Gujarat, India
    Sri Sai Overseas Recruitments is a manpower recruitment and consultancy service provider established in 2019.It is led by professionals with extensive experience in the Gulf countries, particularly...Show moreLast updated: 18 days ago
    Clinical Evaluation Specialist

    Clinical Evaluation Specialist

    Stryker Global Technology Center Pvt Ltd.Bangalore, India
    Detail-oriented process improvers.Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.People who take owner...Show moreLast updated: 30+ days ago
    Senior Medical Writer

    Senior Medical Writer

    IndegeneIndia
    Good medical / pharma / scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under ...Show moreLast updated: 18 days ago
    • Promoted
    Senior Medical Writer

    Senior Medical Writer

    Veeda LifesciencesAhmedabad, Gujarat, India
    Proficiency in organizing and communicating clinical information.Scientific writing, Protocols, CT writing, Drugs.Excellent attention to detail, consistency, clarity and scientific rigor.Continuous...Show moreLast updated: 2 days ago
    Senior Medical Information Writer

    Senior Medical Information Writer

    SANOFIINDIA
    Responsible for research and authoring of scientific response documents under the direction of the Global Medical Information (GMI) team in support of global and local medical information activitie...Show moreLast updated: 30+ days ago
    Senior Clinical Evaluation Report(clinical writer)

    Senior Clinical Evaluation Report(clinical writer)

    SiemensBengaluru, Karnataka, India
    We are looking to add an experienced Clinical Writer to our team.The person in this position must be able to independently contribute to the development of initial and update(s) of CER’s that suppo...Show moreLast updated: 13 days ago
    Senior Clinical Evaluation Author

    Senior Clinical Evaluation Author

    Siemens Healthcare Private LimitedBengaluru, Karnataka, India
    We are looking to add an experienced Clinical Writer to our team.The person in this position must be able to independently contribute to the development of initial and update(s) of CER’s that suppo...Show moreLast updated: 13 days ago
    Senior Medical Writer

    Senior Medical Writer

    StrykerINDIA
    This position requires professional mastery of a specialized field of regulatory expertise that typically requires a bachelors degree in engineering, science, or equivalent focus or equivalent cert...Show moreLast updated: 30+ days ago
    Medical Writer

    Medical Writer

    Weekday AIMumbai, MH, IN
    Quick Apply
    This role is for one of the Weekday's clients.Salary range : Rs 900000 - Rs 1000000 (ie INR 9-10 LPA).Qualifications & Experience. Master’s degree or higher in Life Sciences, Healthcare, Pharmacy...Show moreLast updated: 2 days ago
    Senior Medical Copy Writer

    Senior Medical Copy Writer

    INDEGENEINDIA
    We are a technology-led healthcare solutions provider.We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent...Show moreLast updated: 15 days ago
    • Promoted
    Senior Medical Writer

    Senior Medical Writer

    MS CLINICAL RESEARCHBengaluru, Karnataka, India
    Job Title : Senior Medical Writer – Consultant.Minimum 10 years in medical / scientific writing.Consultant – Part-time / Project-based / Remote. MSCR is seeking a highly experienced.Senior Medical Writer –...Show moreLast updated: 14 days ago
    Senior Medical Writer

    Senior Medical Writer

    GSKINDIA
    Clinical and Regulatory document writing, CSR, Briefing Document, Module (m2.The Senior Medical Writer is expected to work on assignments largely independently or for complex documents, under guida...Show moreLast updated: 30+ days ago
    Medical Content Writer

    Medical Content Writer

    PEOPLEOCITY LLPMumbai Suburban, Maharashtra, India
    Develop high-quality scientifically accurate content for various formats including manuscripts white papers slide decks brochures and digital media websites blogs social media newsletters and scien...Show moreLast updated: 15 days ago
    Senior Regulatory Medical Writer Clinical trials

    Senior Regulatory Medical Writer Clinical trials

    Jeevan Scientific Technology LimitedINDIA
    Senior Regulatory Medical Writer Clinical trials.The Regulatory Medical Writer-Clinical trials (RMW-CT) is responsible for providing regulatory affairs (RA) strategic document expertise and suppor...Show moreLast updated: 30+ days ago
    Senior Medical Writer

    Senior Medical Writer

    ParexelRemote, Bengaluru, India
    Remote
    When our values align, there's no limit to what we can achieve.The SMW will be responsible for authoring the signal management reports including Validations, SERs, HA requests etc.The scientist wil...Show moreLast updated: 27 days ago