Overview
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.
This role can be based at either our UK Head Office situated in Uxbridge or be fully homebased in the UK. We are near to Uxbridge train station as well as the town centre and the building has plenty of free onsite parking. The office is open planned, and you will be working in an innovative and collaborative global environment.
As the Manager, Medical Writing Services you will be responsible for line management of assigned medical writing staff, including development and retention, either at the local site or remotely. You will research, create, and edit documents associated with the clinical sections of regulatory submissions and other clinical documents. You will also provide project management of the medical writing aspect for their projects and those of their line reports. You may also have responsibilities as a client liaison or partnership lead, and may support MWS management during the sales process by leading client interactions, proposals input, and contract review.
Key Accountabilities:
Line and General Management
– Supervise and mentor line reports, including all aspects of MWS personnel management: hiring, training, professional development, periodic/annual performance evaluations, compensation recommendations, promotions, team-building, morale, motivation, and supervision of adherence to departmental procedures and health authority guidance and regulations.
– Validate quality and training compliance.
– Ensure appropriate billable time for line reports.
Client Liaison/Service
– Be aware of client expectations for self and team members/line reports.
– Build and maintain collaborative client relationships, to cultivate efficient, productive, and professional working relationships that promote satisfaction and confidence.
Project Management
– As applicable, manage individual, partner, stakeholder, and customer relationships and their performance; manage partnership operations, relationships, and personnel.
– Set clear objectives for assigned Medical Writing team members/line reports and continuously monitor performance against these objectives.
– Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks.
Author Clinical Documents/ Consultancy
– In line with client requirements, gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize any type of medical writing deliverable without the need for any supervision or formal training, including those for which little or no regulatory or other guidance is available.
– Advise on medical writing regulatory issues and submissions, as detailed in current ICH, FDA, EMA, and other applicable guidelines.
Quality Control
– Strive to ensure internal and external clients receive a quality product on time, all of the time.
– Ensure projects assigned to line reports are completed with quality, according to SOPs, and on time.
Training/ Compliance
– Keep abreast of new advances in medical writing, regulatory updates, and industry trends.
– Develop training materials and present to MWS staff to enhance writing quality, efficiency, and project management.
General
– Maintain a positive, results-oriented work environment, building partnerships and modelling teamwork, communicating to the team in an open, balanced, and objective manner.
– Provide short-term ‘basic’ coverage in the absence of other MWS management.
Qualifications
Education:
– Bachelor’s degree or higher in Life Sciences/Health Related Sciences or equivalent
Skills:
– Excellent interpersonal, negotiation, verbal and written communication skills.
– A professional and flexible attitude with respect to work assignments and new learning.
– Motivation to work independently and 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 logical thinking and sound judgement. Escalates issues to departmental management as appropriate.
– Presents solutions and follows through to ensure problems have been satisfactorily resolved.
– Demonstrates a client-focused approach to work. Establishes a connection with the client, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company.
– Provides departmental expertise and perspectives to promote prospective business opportunities; provides Parexel colleagues with pertinent information to formalize a sound business strategy.
Knowledge and Experience:
– Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.
– Strong previous advanced level clinical medical writing experience.
– Broad experience in management of complex medical writing projects.
– Understanding of people management: previous line management experience, or equivalent, preferably in a billable service industry where you have managed a Clinical Medical Writing team.
– Project management experience (e.g., planning and monitoring).
– Business awareness/business development experience.
– Knowledge of resource management and productivity metric management.
– Advanced word processing skills, including Microsoft (MS) Office (expertise in Word and competency in Excel); 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 (e.g., MS Access).
– Ability to travel.
– Fluent in written and spoken English.
In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, company car or car allowance, bonus and a benefits package including holiday, pension, life assurance, healthcare and other leading edge benefits that you would expect with a company of this type.
Apply today to begin your Parexel journey!
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Parexel
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Medical and Health Services Managers