Senior Medical Writer - Bloemfontein at PAREXEL

Key Accountabilities:

Author Clinical Documents

• Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy.
• Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.

Quality Control

• Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
• Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.

Project Management

• Operate as the project lead writer/submission coordinator and primary client Management contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project.
• Develop, coordinate, and oversee work plans for individual and multiple document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives.
• Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. 

Client Liaison/Service

• Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management.
• Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon.

Training/Compliance

• Keep abreast of new advances in medical writing and regulatory issues.
• Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management.
• Implement and monitor departmental compliance to SOPs. Input to development or revision of departmental SOPs, as appropriate.

General 

•  Attend departmental and company meetings as necessary.
• Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform
• Analyze efficiency of work and discuss improvement ideas with Medical Writing Services management and colleagues.

Education:

• Bachelor's degree in Life Sciences/Health Related Sciences or equivalent

Skills:

• Excellent interpersonal, negotiation, verbal, and written communication skills.
• A flexible attitude with respect to work assignments and new learning.
• Motivation to work consistently in a fast-paced, rapidly changing environment.
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
• Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity.
• Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved.
• Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
• Understands and satisfies client needs.
• Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company.

Knowledge and Experience:

• Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
• Extensive clinical/scientific writing skills acting as either a Senior Medical Writer or Principal Medical Writer
• Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
• Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
• Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.