Senior Executive - Bengaluru, India - Syngene

    Syngene
    Syngene Bengaluru, India

    2 weeks ago

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    Description

    JOB DESCRIPTION

    Designation: Senior Executive – Medical Writing
    Job Location: Bangalore
    Department: Clinical Development

    About Syngene
    Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene' s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

    Key Responsibilities:

    • Independently develops and finalizes clinical and scientific documents such as (but not limited to) synopses, protocols, investigator brochures, CSRs, ICDs, relevant regulatory documents and clinical documents, eCTD modules, scientific communication documents such as abstracts, posters, presentations, and manuscripts etc. covering various therapeutic areas and all phases of clinical research

    • Performs literature search/review as necessary to obtain background information for developing scientific content

    • Collaborates with internal and external clients to support and enable effective communication resulting in operational excellence

    • Effectively manages medical writing and review processes to deliver quality projects in agreed timelines

    • Ensure compliance to applicable regulatory guidelines, department SOPs, client style guides, conventions as applicable

    • Collaborates with clinicians, clinical scientists, and biostatisticians to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents

    • Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TLFs and other information sources.

    • Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations

    • Creates and maintains SOPs and work instructions for preparation and maintenance of compliant medical/scientific writing deliverables

    • Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables and responds to findings

    • Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity

    • Review of drafts including content review, QC, and editing of drafts and final documents prepared by other/junior team members before sharing with internal and external client

    • Guide and mentor junior team members by providing appropriate trainings

    • Follow any other instructions and perform any other related duties, as assigned by the supervisor

    • Possess the knowledge and exposure to environment, health, and safety (EHS) practices

    • Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety

    Educational Qualification:

    • M. Pharm

    Technical/functional Skills:

    • Substantial knowledge of / previous experience in varied therapeutic areas, regulatory and medical guidelines and key statistical concepts

    • Logical and succinct writing with accurate data interpretation and representation

    • Experienced in literature search: have a well-planned search strategy, appropriate keywords and a variety of sources when researching journal articles and medical research papers

    • Ability to write to / for an audience and understand writing for regulators, scientists and doctors, versus writing for consumers and the general public

    Experience:

    • 5-8 years of relevant experience.

    Behavioral Skills:

    • Good Communication skills

    Equal Opportunity Employer:
    It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.