Aspen Jobs – Medical Writer

Job Description:

We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversified by geography, product and manufacturing capability.

Aspen is a dynamic organisation built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At aspen, not only do we source for the best talent but we also provide a host of opportunities for continuous development.

The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established officesin over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.

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Job Responsibilities:

• Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs
• Adhere to agreed Key Performance Indicators (KPIs).
• Support the continuous development and improvement of the PV function while upholding Aspen core values.
• Project management of contractual and financial aspects of all medical writing projects and the effective utilization of resources to keep processes cost effective.
• Identification of project challenges to departmental line management and the financial impact thereof.
• 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, and other duties as assigned.
• 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.
• 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/SAHPRA or other appropriate regulatory guidelines, and complies with departmental and corporate SOPs and style guidelines
• Perform literature searches/reviews to obtain background information and training for development of documents
• Prepare country specific packs for submission of safety variations within ZA and other territories
• 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.

Job Requirements:

• 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
• Results and performance driven – deliver results that meet or exceed expectations
• Integrity
• Work ethic
• Ability to meet deadlines
• 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
• Manage evolving deadlines effectively with regular feedback and updates
• Enthusiasm and Drive to take ownership and drive process initiatives
• Service orientation
• Matric/ Grade 12
• B.Sc. (Hons) or equivalent scientific qualification
• 4yrs experience in pharmaceutical clinical research expertise.

Job Details:

Company: Aspen Pharma

Vacancy Type: Full Time

Job Location: Gauteng, South Africa

Application Deadline: N/A

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