Senior Medical Writer (Bloemfontein or Centurion, South Africa)
Parexel International Corporation
Bloemfontein, Orange Free State, South Africa
4d ago
  • The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include : acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal / external deliverable timelines, project leadership, and training and support of junior medical writing staff.
  • The SMW gathers, reviews, analyzes, and evaluates 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.
  • It has to be ensured that all work is complete and of high quality prior to team distribution or shipment to client; referring to data consistency and integrity, publishing readiness, adherence to regulatory guidelines, compliance with departmental, corporate or client SOP's and style guidelines.
  • The SMW acts in the capacity of project manager / lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues.
  • Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.

  • Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership : communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead / facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage / drive the timeline, and advance document development to approval, according to Parexel or client guidelines / SOP's.
  • Distribute final documents to project team and client.Qualifications

  • Excellent interpersonal, verbal, and written communication skills.
  • Ability to consistently produce documents of high quality.
  • Demonstrates attention to details and pro-activity.
  • Ability to understand all necessary steps in a project, plan ahead, and identify critical paths.
  • A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
  • Ability to efficiently manage time spent on tasks and proactively identify deficiency. 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.
  • Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
  • Understands and satisfies client needs.
  • Gains trust and establish a connection with the client beyond one's project, to gain repeat business and / or to widen existing scope and services.
  • Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy.
  • Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
  • Extensive clinical / scientific writing skills.
  • 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.
  • If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite.
  • Education :

  • Bachelor's degree in Life Sciences / Health Related Sciences or equivalent.
  • 2020-06-25 01 : 00 : 45

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