20 Pharmaceutical Writer jobs in South Africa

COMPANY 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 diversi?ed by geography, product and manufacturing capability.
Aspen is a dynamic organization 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 offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.

OBJECTIVE OF ROLE
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 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 for the New Product Launch Pipeline and the existing product portfolio in the region, through the successful completion of assigned activities according to the South African and SADC Regulatory plan. To establish a central point of contact for all medical writing project 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 accordingly 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, 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.
·    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 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:

o   clinical overviews and summaries
o   clinical expert statements
o   interim and final clinical study reports
o   integrated summaries of safety and efficacy
o   nonclinical overviews and summaries
o   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
·    Assist in the assessment of clinical and nonclinical documentation with   regards to its suitability for supporting new marketing authorisation applications (MAA) or new indications.
·    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, 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.
·    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.
·    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/WIs.
·    Keep abreast of professional information and technology through  
·    workshops and conferences and ensure the appropriate transfer of that information to the department.
·    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.
·    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.

EDUCATIONAL REQUIREMENTS
·    Matric/ Grade 12
·    B.Pharm (preferred); B.Sc. (Hons), B Sc. Pharmacology or equivalent scientific or clinical qualification
 
KNOWLEDGE & EXPERIENCE REQUIREMENTS
·    4 Years experience in pharmaceutical industry (clinical 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
 
SOFT SKILLS REQUIREMENTS
·    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.
 
COMPUTER SKILLS REQUIRED
The applicant must be proficient in the various applications (Word, Excel and PowerPoint) within the Microsoft Office bundle.

 
Preference will be given to previously disadvantaged groups. Suitably qualified applicants are invited to submit their CV’s online on or before 1 June 2025. Please note that if you have not heard from the HR department within 30 days of this advert closing, your application has unfortunately been unsuccessful.
 
Internal Applications must be completed using an Aspen mailing address after applicants have had informed their direct line managers of their application for this specific role.

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn .

Senior MedicalWriter

We are recruiting for aMedicalWriter to take on a vacant position in our South Africa team. We are looking for a motivated self-starter, preferably withmedicalwriting experience who is looking for a fresh challenge. This position is a home-based role out of any locationin South Africa.

Roles & Responsibilities

• Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
• Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing assignments
• Practice good internal and external customer service
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with client templates & style guides
• Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
• Contribute substantially to, or manages, production of interpretive guides
• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
• Mentor medical writers and other members of the project team who are involved in the writing process

Requirements

• At least 3 years of previous experience in the pharmaceutical industry
• Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
• The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
• Substantial Oncology experience required
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Understanding of clinical data
• Exceptional writing skills are a must
• Excellent organizational skills and the ability to multi-task are essential prerequisites
• Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
• Experience being a project lead, or managing a project team
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Not required, but experience with orphan drug designations and PSP/PIPs a plus

Please consider your application unsuccessful if we do not reach out to you within 14days of your submission.

#J-18808-Ljbffr

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn .

Senior MedicalWriter

We are recruiting for aMedicalWriter to take on a vacant position in our South Africa team. We are looking for a motivated self-starter, preferably withmedicalwriting experience who is looking for a fresh challenge. This position is a home-based role out of any locationin South Africa.

Roles & Responsibilities

• Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
• Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing assignments
• Practice good internal and external customer service
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with client templates & style guides
• Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
• Contribute substantially to, or manages, production of interpretive guides
• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
• Mentor medical writers and other members of the project team who are involved in the writing process

Requirements

• At least 3 years of previous experience in the pharmaceutical industry
• Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
• The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
• Substantial Oncology experience required
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Understanding of clinical data
• Exceptional writing skills are a must
• Excellent organizational skills and the ability to multi-task are essential prerequisites
• Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
• Experience being a project lead, or managing a project team
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Not required, but experience with orphan drug designations and PSP/PIPs a plus

Please consider your application unsuccessful if we do not reach out to you within 14days of your submission.

#J-18808-Ljbffr

Senior Medical Writer (Home Based - South Africa)

MMS Cape Town, Western Cape, South Africa

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Senior Medical Writer (Home Based - South Africa)

MMS Cape Town, Western Cape, South Africa

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Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn.

Senior Medical Writer

We are recruiting for a Medical Writer to take on a vacant position in our South Africa team. We are looking for a motivated self-starter, preferably with medical writing experience who is looking for a fresh challenge. This position is a home-based role out of any location in South Africa.

Roles & Responsibilities

• Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
• Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing assignments
• Practice good internal and external customer service
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with client templates & style guides
• Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
• Contribute substantially to, or manages, production of interpretive guides
• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
• Mentor medical writers and other members of the project team who are involved in the writing process
  
  

Requirements

• At least 3 years of previous experience in the pharmaceutical industry
• Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
• The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
• Substantial Oncology experience required
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Understanding of clinical data
• Exceptional writing skills are a must
• Excellent organizational skills and the ability to multi-task are essential prerequisites
• Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
• Experience being a project lead, or managing a project team
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Not required, but experience with orphan drug designations and PSP/PIPs a plus
  
  

Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.

Seniority level

• Seniority level Mid-Senior level

Employment type

• Employment type Full-time

Job function

• Job function Marketing, Public Relations, and Writing/Editing
• Industries Pharmaceutical Manufacturing

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#J-18808-Ljbffr

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn .

Senior MedicalWriter

We are recruiting for aMedicalWriter to take on a vacant position in our South Africa team. We are looking for a motivated self-starter, preferably withmedicalwriting experience who is looking for a fresh challenge. This position is a home-based role out of any locationin South Africa.

Roles & Responsibilities

• Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
• Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing assignments
• Practice good internal and external customer service
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with client templates & style guides
• Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
• Contribute substantially to, or manages, production of interpretive guides
• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
• Mentor medical writers and other members of the project team who are involved in the writing process

Requirements

• At least 3 years of previous experience in the pharmaceutical industry
• Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
• The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
• Substantial Oncology experience required
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Understanding of clinical data
• Exceptional writing skills are a must
• Excellent organizational skills and the ability to multi-task are essential prerequisites
• Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
• Experience being a project lead, or managing a project team
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Not required, but experience with orphan drug designations and PSP/PIPs a plus

Please consider your application unsuccessful if we do not reach out to you within 14days of your submission.

#J-18808-Ljbffr

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn .

Senior MedicalWriter

We are recruiting for aMedicalWriter to take on a vacant position in our South Africa team. We are looking for a motivated self-starter, preferably withmedicalwriting experience who is looking for a fresh challenge. This position is a home-based role out of any locationin South Africa.

Roles & Responsibilities

• Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
• Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing assignments
• Practice good internal and external customer service
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with client templates & style guides
• Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
• Contribute substantially to, or manages, production of interpretive guides
• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
• Mentor medical writers and other members of the project team who are involved in the writing process

Requirements

• At least 3 years of previous experience in the pharmaceutical industry
• Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
• The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
• Substantial Oncology experience required
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Understanding of clinical data
• Exceptional writing skills are a must
• Excellent organizational skills and the ability to multi-task are essential prerequisites
• Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
• Experience being a project lead, or managing a project team
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Not required, but experience with orphan drug designations and PSP/PIPs a plus

Please consider your application unsuccessful if we do not reach out to you within 14days of your submission.

#J-18808-Ljbffr

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn .

Senior MedicalWriter

We are recruiting for aMedicalWriter to take on a vacant position in our South Africa team. We are looking for a motivated self-starter, preferably withmedicalwriting experience who is looking for a fresh challenge. This position is a home-based role out of any locationin South Africa.

Roles & Responsibilities

• Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
• Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing assignments
• Practice good internal and external customer service
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with client templates & style guides
• Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
• Contribute substantially to, or manages, production of interpretive guides
• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
• Mentor medical writers and other members of the project team who are involved in the writing process

Requirements

• At least 3 years of previous experience in the pharmaceutical industry
• Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
• The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
• Substantial Oncology experience required
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Understanding of clinical data
• Exceptional writing skills are a must
• Excellent organizational skills and the ability to multi-task are essential prerequisites
• Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
• Experience being a project lead, or managing a project team
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Not required, but experience with orphan drug designations and PSP/PIPs a plus

Please consider your application unsuccessful if we do not reach out to you within 14days of your submission.

#J-18808-Ljbffr

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team?MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on Linked In . Senior Medical Writer We are recruiting for a Medical Writer to take on a vacant position in our South Africa team. We are looking for a motivated self-starter, preferably withmedicalwriting experience who is looking for a fresh challenge. This position is a home-based role out of any locationin South Africa. Roles & Responsibilities Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals Complete writing assignments in a timely manner Maintain timelines and workflow of writing assignments Practice good internal and external customer service Highly proficient with styles of writing for various regulatory documents Expert proficiency with client templates & style guides Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects Contribute substantially to, or manages, production of interpretive guides Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary Mentor medical writers and other members of the project team who are involved in the writing process Requirements At least 3 years of previous experience in the pharmaceutical industry Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience The ideal candidate would hold a Bachelors, Masters, or Ph. D. in scientific, medical, clinical discipline Substantial Oncology experience required Substantial clinical study protocol experience, as lead author, required Experience leading and managing teams while authoring regulatory documents with aggressive timelines Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus Understanding of clinical data Exceptional writing skills are a must Excellent organizational skills and the ability to multi-task are essential prerequisites Candidate must be an expert in MS Word, Excel, Power Point, and related word processing tools Experience being a project lead, or managing a project team Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus Substantial clinical study protocol experience, as lead author, required Experience leading and managing teams while authoring regulatory documents with aggressive timelines Not required, but experience with orphan drug designations and PSP/PIPs a plus Please consider your application unsuccessful if we do not reach out to you within 14days of your submission. #J-18808-Ljbffr

Main Purpose of the role: This role is responsible for the planning, executing, monitoring, controlling, and closing of Business projects in support of business objectives and ongoing operations. This includes managing projects and producing required artefacts in accordance with the Bank's project management methodology. The project manager is the key point of contact among project stakeholders. Must interact with Business, value chain enablers, and customers to ensure that the business requirements and objectives are clearly defined. Hybrid role of project management (PM) and business analysis (BA). Responsibilities Project Management Planning and Scoping Identify key stakeholders and build on these relationships. Interact with Business, value chain enablers, and customers to ensure that the business requirements and objectives are clearly defined. Translate business requirements and objectives into detailed project plans, specifying goals, strategy, staffing, scheduling, identification of risks, contingency plans, allocation of resources and cost estimation. Ensure that the scope of the project, related business requirements, and technical requirements are reduced into writing and signed-off by the respective stakeholders. Adjust schedules and plans to keep the plan updated. Project Execution Execute project work plan and revise as appropriate to meet changing needs and requirements. Track and monitor project deliverables to the project plan. Co-ordinate and facilitate regular status meetings with the partner and project team members. Effectively apply business methodologies and enforce project standards. Provide ongoing feedback to senior management and stakeholders in respect of milestones, any slippage, issues, and risks. Attend IT rag sessions to provide feedback where necessary. Identify potential risks, issues and maintain a monthly project risk register, issue log sheet and ensure mitigation plans are in place. Ensure that all project life cycle deliverables are baselined and booked into a documentation repository. Continuous communication with stakeholders and information distributed to all stakeholders and management. Stakeholder Management Liaise with various project sponsors and assigned business analysts (direct or indirect reports). Forge strong value chain relationships in support of the business functions ambitions. Apply professional standards in the engagement and communication with internal stakeholders, customers, 3rd parties, and regulators. Keep stakeholders continuously informed about progress through clear communication. Build a positive image of the Bank and exceed client expectations at all times. Treat internal and external customers fairly at all times. Business Analysis Support business in the enablement of onboarding new partners, products, or business lines. Play an instrumental role in supporting the overall integration between 3rd parties and the Bank's internal value chain. Take ownership and ensure specifications and business requirements are fit for purpose, customer-friendly, and conform to the Bank's standards. Lead and/or give input to joint application design (JAD) sessions and provide the required output/feedback where necessary. Arrange and co-ordinate specification and requirements sign-off, and handover meetings between various stakeholders. Ensure that specifications and business requirements are updated periodically and stored where such is easily accessible for stakeholder consumption. Ensure that the policies and procedures of the Bank across all the new partners are implemented effectively. Revenue and Costs Implement project activities and new business timeously, which directly influences the generation of fees, interest income, and customer growth for the Bank. Ensure the timely delivery of projects, limiting rework to safeguard delayed revenues, ensuring that revenue generation is expedited without placing the Bank at risk. Limit any unexpected costs due to any project delays. Role Requirements: Project Management qualification or certification (CAPM, PMP, SCRUM) or a Bachelor's Degree in Computer Science, Information Systems, or related field. Minimum of 3 years business analysis experience. Minimum of 3 years project management experience, preferably in a banking environment. Experience managing projects following the PMBOK and/or Agile/Scrum methodologies. Experience managing software development or integration projects will be highly advantageous. #J-18808-Ljbffr