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  • Posted: May 15, 2020
    Deadline: Not specified
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    Aspen has a proud heritage dating back more than 160 years and is committed to sustaining life and promoting healthcare through increasing access to its high quality affordable medicines and products. Aspen has a market capitalisation of approximately US$10 billion, is the largest pharmaceutical company listed on the JSE Limited (share code: APN) and rank...
    Read more about this company

     

    Medical Writer

    ROLE PURPOSE:

    To establish a central point of contact for all medical writing projects for the Pharmaceutical Affairs entity of the Aspen Group by liaising with other Pharmacare departments as the need arises. To undertake all research, creation and editing of all documents to comply with safety and clinical updates according to the Pharmacare Company Core Datasheet (CCDS) products. 

     

    SPECIFIC OUTCOMES / ACCOUNTABILITY:

    To establish a central point of contact for all medical writing projects for the Pharmaceutical Affairs entity of the Aspen Group by liaising with other Pharmacare departments as the need arises. To undertake all research, creation and editing of all documents to comply with safety and clinical updates according to the Pharmacare Company Core Datasheet (CCDS) products. 

    Financial

    • Project management of contractual and financial aspects of all medical writing projects and the effective utilisation of resources to keep processes cost effective. 
    • Identification of project challenges to departmental line management and the financial impact thereof.

    Project Management

    • Act in the capacity of project manager/lead for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues 
    • Project management of contractual and financial aspects to be performed with management where necessary
    • Serve as the Medical Writing representative to provide proactive support for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options
    • Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to Pharmacare guidelines/SOPs
    • Coordinate production and distribution of draft and final documents to regulatory teams. Ensure that all work is complete and of high quality prior to team distribution
    • Attend internal and technical team meetings as required
    • Assist management as needed with preparation of resourcing estimates for potential new medical writing projects
    • Proactively engage with other departmental resources where necessary to ensure that information/documentation requests are delivered in a professional and timeous manner 

    Medical Writing Accountabilities

    • Ensure defined framework as set by PV Manager or Executive are executed;
    • Write clinical documents for submission to regulatory authorities, including but not limited to: 
    • clinical overviews and summaries
    • clinical expert statements
    • interim and final clinical study reports
    • integrated summaries of safety and efficacy
    • nonclinical overviews and summaries, where applicable
    • Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review
    • Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate SOPs and style guidelines
    • Perform literature searches/reviews as necessary to obtain background information and training for development of documents
    • Prepare country specific packs for submission of safety variations within CA, EU, US and other territories as needed
    • Assist in the assessment of clinical and nonclinical documentation with regards to its suitability for supporting new marketing authorisation applications (MAA) or new indications
    • Adherence to Company Health & Safety procedures
    • Participate in training programmes
    • Any other duties as assigned by your Manager

    Safety

    • Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports
    • Preparation of Risk Management Systems including but not limited to Risk Management Plans, Dear Healthcare Professional Letters and Risk Communication Plans
    • Manage safety related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly

    Training

    • Provide training and guidance and act as a mentor to less experienced departmental members
    • Initiate and participate in departmental or interdepartmental process improvement and training initiatives
    • Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures 
    • Assist in the development of departmental SOPs/WINs
    • Keep abreast of professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the department

    General

    • Maintain rigorous adherence to written procedures, e.g. SOPs/WINs
    • Adherence to Company Health & Safety procedures
    • Participate in training programmes
    • Any other duties as assigned by your Manager

     

    EDUCATION AND EXPERIENCE:

    • B.Sc (Hons) or equivalent scientific qualification
    • 4yrs experience in pharmaceutical clinical research expertise
    • Strong knowledge of regulatory and medical authorities in South Africa
    • Strong understanding of regulations, ICH guidelines, and GCP
    • Extensive medical writing and expertise in submission

    COMPETENCIES – SKILLS & ATTRIBUTES:

    • Results and performance driven – deliver results that meet or exceed expectations
    • Sense of urgency – responding to issues and opportunities in a timely manner
    • Intellectual curiosity – willing to suggest and try new ideas
    • Positive and pro-active approach to business tasks
    • Excellent interpersonal and communication skills
    • A solutions provider with strong multi-tasking abilities
    • Manage evolving deadlines effectively with regular feedback and updates
    • Enthusiasm and Drive to take ownership and drive process initiatives
    • Service orientation
    • Customer focused
    • Logical thinking
    • Information seeking
    • Positive ‘can – do’ attitude
    • Be able to work autonomously and have good problem solving skills
    • Able to cope with evolving deadlines effectively with regular feedback and updates
    • Honest and trustworthy
    • Respectful and highly personable
    • Possess cultural awareness and sensitivity
    • Flexibility & confidentiality are key requirements for this role.

     

    ASPEN COMPETENCIES:

    Business

    • Make Good Decisions - Being solution orientated, innovative, agile and proactive. Good decisions are informed decisions
    • Accountability/Ownership - employees readily accept responsibility, own decisions and achieve results despite adverse conditions

    People

    • Communicate Effectively – Informal communications skills. Active listening skills, Writing skills, Presentation skills, Meeting facilitation, Empathy
    • Leads and influence others – work collaboratively with others to achieve departmental goals

    Self

    • Continuously Grows & Develops - staying competitive means continually increasing knowledge, skills and capabilities
    • Takes action with Integrity - Aspen employees must internalise the principles of the Aspen Code of Conduct and demonstrate integrity, fairness, accountability, respect, transparency and sincerity

    Method of Application

    Interested and qualified? Go to Aspen Pharma Group on aspen.mcidirecthire.com to apply

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