Medical Writer (JHB North) at Aspen Pharma Group

OBJECTIVES: 

• To support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of the current product portfolio in the South Africa and South African Development Community (SADC) region, by ensuring successful Marketing Authorisation and variation approval from the SAHPRA and Regulatory Authorities of the SADC member states within the committed timeframe.
• The role undertakes responsibility for compliance with the regulatory / pharmacovigilance requirements.
• New Product Launch Pipeline and the existing product portfolio in the region, through successfully completing assigned activities according to the South African and SADC Regulatory plan.
• To establish a central point of contact for all medical writing projects for the Regulatory Affairs South Africa 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).

KEY RESPONSIBILITIES 

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, 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 the 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 the 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 Lead, RA Manager: Safety, Quality and Compliance, or Head of Department are executed 
  within the specified timelines.
• 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
• 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 the development of documents.
• Prepare country-specific packs for submission of safety variations within ZA.
• Assist in the assessment of clinical and nonclinical documentation with   regards to its suitability for supporting new marketing authorisation applications (MAA) or new indications.

SAFETY

• Aggregate reporting:
  • Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports.
• Risk Management System:
  • Preparation of Risk Management Systems including but not limited to Risk Management Plans, Healthcare Professional Letters and Risk Communication Plans.
• Request for Information from Competent Regulatory Authorities (CRAs):
  • Manage safety-related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly.
• Signal Management:
  • Assessment of local PI/PIL for inclusion of the validated signal.
• Data analysis of signals and feedback to the Safety Review Team (SRT) during the Signal Management meetings.

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 the development of formats, templates and general guidelines for clinical documentation and workflow procedures.
• Assist in the development of departmental SOPs/WIs.
• Keep abreast of professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the department.

GENERAL

• Ensure systems and procedures are in place following 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's core values.
• Maintain rigorous adherence to written procedures, e.g. SOPs/WIs.     
• Adherence to Company Health & Safety procedures.
• Participate in training programmes.
• Any other duties as assigned by your Manager. 

EDUCATION & EXPERIENCE

• Matric/ Grade 12
• B.Pharm (preferred); B.Sc. (Hons) or equivalent scientific or clinical qualification
• 4yrs experience in pharmaceutical industry (clinical expertise)

KNOWLEDGE

• 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.

SKILLS AND ATTRIBUTES

• 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.
• 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.