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    Sr Assoc - Scientific Writing

    Indegene
    3+ years
    Not Disclosed
    Bangalore
    10 Oct. 14, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Join Us at Indegene: A Technology-Driven Healthcare Solutions Provider

    At Indegene, we empower healthcare organizations to be future-ready through innovative technology solutions. We offer accelerated global growth opportunities for bold, industrious, and agile talent. With us, you’ll enjoy a unique career experience that celebrates entrepreneurship, guided by passion, innovation, collaboration, and empathy. Explore exciting opportunities at the convergence of healthcare and technology at www.careers.indegene.com.

    What if you could step into an exciting role in an entrepreneurial organization—risk-free?

    We understand that you’re looking for growth and variety in your career, and we invite you to join us on this journey. At Indegene, our roles provide the excitement you seek, paired with the reliability you desire. We focus on creating tomorrow’s leaders, mentoring our team members to grow as people and account managers.

    As a rapidly growing global organization, we are scouting for top talent to join us during this exciting phase. With us, you’ll be at the intersection of two dynamic industries: healthcare and technology. We offer global opportunities and fast-tracked career paths while working with a purpose-driven team, ensuring a truly differentiated experience.

    If this excites you, apply below!

    Senior Associate - Scientific Writing

    Responsibilities:

    • Author clinical evaluation reports, clinical evaluation plans, post-market surveillance reports, and periodic safety update reports.
    • Serve as the primary point of contact for clients regarding daily communications for assigned deliverables.
    • Draft queries for project kick-off meetings and maintain an asset tracker related to deliverables.
    • Review assets received from clients and request additional documents as needed.
    • Align with peer reviewers and project leads on timelines for deliverables.
    • Acquire knowledge of therapeutic areas, competitor devices, and current clinical/market developments.
    • Conduct comprehensive literature searches to support product lines and related clinical studies.
    • Stay updated on applicable clinical landscapes and trends.
    • Review literature search results and summarize risks, alternative therapies, and device-specific benefits.
    • Critically appraise scientific literature and write clinical summaries to elucidate clinical problems and current treatment techniques.
    • Evaluate data for similar competitor devices and perform data fact-checking on authored documents.
    • Ensure compliance with client and regulatory requirements and participate in client calls as needed.
    • Adhere to quality, confidentiality, and security protocols.
    • Maintain quality systems, processes, and policies, and ensure all open action items in drafts are communicated to clients.
    • Collate medical writer and reviewer CVs and DOIs, and perform a self-quality check before sharing drafts for review.
    • Draft minutes of meetings from client calls and share them with clients.
    • Guide team writers in literature searches and clinical evaluation plans and reports, providing peer review and quality checks.

    Your Impact:

    About You: (Desired Profile)

    • Understanding of medical devices or a general understanding of the medical field.
    • Familiarity with EU MDR, MEDDEV 2.7.1 Rev 4, IMDRF, and MDCG.
    • Strong passion for technical writing.
    • Excellent written and verbal communication and presentation skills.
    • Up-to-date with the latest technical and scientific developments relevant to projects.

    Must Have: (Requirements)

    • Graduate or postgraduate degree in Life Sciences (Pharm.D/M.Pharm/BDS/MBBS) or Biomedical Engineering with 4 to 6 years of experience.
    • At least 3 years of experience in the medical device clinical affairs domain.
    • Ability to identify critical information needs and engage the appropriate individuals for decision-making in clinical evaluation assessments and report development.
    • Strong experience in conducting literature searches and appraising scientific data.
    • Clear and effective communication skills.
    • Excellent critical and analytical thinking skills.
    • Ability to work effectively with cross-functional teams and manage multiple projects.
    • High attention to detail and strong organizational skills.
    • Consistent dedication and a strong work ethic to meet aggressive timelines.

    Nice to Have: (Additional Desired Qualities)

    Equal Opportunity Employer

    Indegene is proud to be an Equal Employment Employer, committed to fostering a culture of inclusion and diversity. We do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristic. All employment decisions will be based on business needs, candidate merit, and qualifications.

    We welcome all qualified applicants without regard to race, color, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristic.

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