Medical Writing Manager

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Posted 1 week ago

Medical Writing Manager

Reports to:  Head Technical Service

Why you’re here

With your experiences with medical writing for clinical development purposes and leadership experience in building/leading a team, you will build and foster a medical writing team capable of providing the expertise, organisation, operations capabilities, and behaviours required to deliver success on medical writing projects at GreenLight Clinical. You will contribute to the business growth of medical writing services with your excellent business acumen. You will contribute to our company culture with your aligned values and purpose.

What you’ll deliver

  • A high competent medical writing team that works well with both internal and external stakeholders
  • Timely and high-quality completion of medical writing deliverables
  • Standards, processes for medical writing services at GreenLight Clinical
  • Continuous business growth of medical writing services through high-quality deliverables, stakeholder’s satisfaction utilising your business acumen skills
  • Contribution to the departmental growth and company culture

How we’ll measure it

  • KPIs related to medical writing projects/processes
  • Stakeholders feedback, including employee engagement
  • Growth of medical writing services

What you’re responsible for

  • Managing and oversight of medical writing projects on a day to day basis to ensure agreed project deliverables are met with quality, and within the allocated timeline and budget, this will also include acting as principal medical writer for assigned projects, or performing peer review
  • Contributing to key clinical and regulatory document content development and critically assess, interpret and summarise data from clinical studies to produce high-quality communications
  • Oversight of adequate resource planning, prioritization, and allocation to ensure medical writing-related projects entrusted to GLC by different sponsors are optimally supported, and delivered with high quality, within timeline and budget
  • Recruiting and hiring appropriate personnel to execute tasks related to medical writing service to execute projects within the established timeframe; providing mentoring and coaching for individual development; ensure goal setting and performance review are performed regularly
  • Developing standards, templates, procedures and optimised processes for medical writing services to ensure consistency in documents developed and service delivered to our sponsors; leading the alignment and consistent implementation of the Medical Writing process.
  • Ensuring adherence to established policies, procedural documents, and templates. Initiating and driving different initiatives related to process improvements, regulatory compliance within medical writing; ensure proper training to the medical writing team, and other relevant cross-functional team members
  • Fostering collaborative working relationships and culture to ensure
  • Management of project budgets for medical services, monitoring and actively communicating out of scope work to ensure proper project budget management for the sponsors through close collaboration with business development, project management, and other cross-functional team members
  • Representing medical service to contribute to new business opportunity acquisition, including but not limited to attending Business development calls with potential sponsors when required, input to project proposal and budget development, attending bid defence meetings
  • Representing GreenLight Clinical to present at industry conferences to promote the company and medical writing services
  • Contributing to departmental leadership through strategic input, continual process improvement, innovation, business growth, and collaboration with internal and external stakeholders 
  • Work closely with Business Development, and other cross-functional members to build and maintain a strong partnership with our sponsors, and key external experts that are important for medical services
  • Contribute to building a strong GLC culture

Qualifications

  • Doctorate degree with 5 years experience of medical writing for clinical development purpose; or master degree with 8 years of medical writing experience for clinical development purpose; or bachelor’s degree with 10 years of medical writing experience for clinical development purpose.

Work experience

  • Minimum 3 years of managerial experience directly managing people, and leadership experience leading cross-functional teams, projects, including allocation of resources
  • Experience in a pharmaceutical/biotech and /or CRO matrix environment is a must, CRO experience preferred, track recordings of effective collaboration on project teams, and cross-functional level

Technical knowledge & skills or other requirements

  • Demonstrated hands-on experience in preparation, review, and completion of clinical and regulatory documents, including protocol, study report, investigator brochure, briefing documents
  • Expert working knowledge of applicable FDA/EMA, TGA regulations, and ICH guidelines
  • Ability to build and maintain effective internal and external relationships
  •  Exceptional verbal and written communication skills, outstanding attention to detail and exceptional judgment and follow-through with assigned projects
  • Demonstrated leadership to drive results to achieve goals, excellent skills in stakeholder management
  •  Strong business acumen, good budgetary management experiences and clinical knowledge
  • Quality mindset and experience with continuous improvement

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