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    Senior Medical Writer

    Beigene
    5+ years
    Not Disclosed
    Remote
    10 Aug. 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

    BeiGene is rapidly expanding and offers exciting opportunities for experienced professionals. We seek motivated and collaborative scientific and business professionals who share our dedication to fighting cancer.

    Job Title: Medical Director, Hematology

    Job Description:

    Overview:

    • Manage or assist in managing a professional and efficient APAC medical writing team, ensuring high-quality writing services for company-wide clinical documents.
    • Supervise and manage the activities of APAC medical writers to ensure timely delivery of high-quality clinical documents.
    • Develop and/or streamline medical writing processes.
    • Manage writing-related vendors as needed.

    Key Responsibilities:

    • Integrate scientific and analytical skills to write critical documents for innovative drugs.
    • Anticipate and manage conflicting perspectives, set expectations, resolve issues, and mitigate risks.
    • Collaborate with cross-functional teams to produce high-quality, scientifically accurate documents under strict timelines, ensuring consistency between related documents.
    • Oversee multiple clinical programs or therapeutic areas, guiding the team in developing documentation roadmaps, including project prioritization, deliverable details, timelines, resources, and issue resolution. Review documents produced by direct reports.
    • Provide guidance and scientific expertise on medical writing aspects of regulatory submissions and contribute to submission strategies.
    • Participate in cross-functional team meetings and assist in resolving document-related issues.
    • Create, maintain, and optimize templates and instructions.
    • Ensure implementation of existing processes, identify areas for improvement, and lead process initiatives that align with R&D needs.
    • Demonstrate strong leadership and contribute to building and streamlining medical writing processes.
    • Work closely with the Project Coordinator and Head of APAC Medical Writing to allocate resources and ensure the smooth progress of medical writing tasks.
    • Collaborate with departmental and interdepartmental stakeholders to support clinical documentation objectives, including resource assignment, process development, and performance management.
    • Enhance the visibility and influence of the medical writing team internally.
    • Develop the skills and capabilities of medical writing team members through coaching, mentoring, and development opportunities.
    • Manage direct reports through hiring, training, goal setting, performance evaluation, career development, and retention.
    • Improve the competencies of direct reports, including writing, project management, and communication skills.
    • Participate in talent development planning for medical writing, including talent identification, competency modeling, and development planning.

    Qualifications:

    • Master’s degree in life sciences, pharmacy, nursing, medical, or health-related sciences; PhD or PharmD in life sciences preferred.
    • At least 5 years of relevant industry experience as a regulatory medical writer.
    • Experience with regulatory requirements for various types of submissions.
    • Ability to influence decision-makers, drive change, and lead process improvement initiatives.
    • Excellent communication skills, both written and verbal.
    • Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems.
    • Expertise in multiple therapeutic areas is a plus.

    BeiGene Global Competencies:

    We strive to exemplify our core values—Patients First, Collaborative Spirit, Bold Ingenuity, and Driving Excellence—through the following competencies:

    • Fosters Teamwork
    • Provides and Solicits Honest and Actionable Feedback
    • Self-Awareness
    • Acts Inclusively
    • Demonstrates Initiative
    • Entrepreneurial Mindset
    • Continuous Learning
    • Embraces Change
    • Results-Oriented
    • Analytical Thinking/Data Analysis
    • Financial Excellence
    • Communicates with Clarity

    Privacy Notice:

    BeiGene is committed to respecting and protecting the personal information of job applicants. We will process applicants' personal data in accordance with applicable laws and regulations. Due to our global operations, data may be stored overseas with adequate protection and will not be kept longer than necessary. For more information, please refer to BeiGene’s Job Applicant Privacy Policy here.

    By voluntarily providing personal information, you consent to BeiGene’s Job Applicant Privacy Policy and relevant privacy terms. If you provide information about other job applicants, you must ensure that they have acknowledged and consented to the policy as required.

    If you have concerns about providing your personal information, please do not submit your resume or other details.

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