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Job Title
Associate Director, Medical Writing Services
Company
PAREXEL International Corporation
Job Description
Parexel.com
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Associate Director, Medical Writing Services
Germany, Remote
Date posted
11/08/2022
Job ID
R0000001793
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Overview
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Responsibilities
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Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.
In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.
Full Time
Travel: No
Glassdoor Reviews and Company Rating
Success Profile
Check out the top traits we’re looking for and see if you have the right mix.
Detail-Oriented
Deadline-Oriented
Communicator
Organized
Versatile
Tech-Savvy
"I really enjoy learning about the vast areas of clinical writing. Everyone is very professional,
knowledgeable, and it is easy to communicate with other staff."
Christine, Medical Writer II
"Parexel makes it easy to communicate and interact with each other, which allows
me access to expertise and knowledge beyond my own."
Kristy, Associate Manager
Rewards
Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
Work-life Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Career Development
Opportunity to learn and grow through a performance and development goal-setting program.
Home based
Love where you work, and work where you love.
Variety
Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.
Responsibilities
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.
Due to growth we are looking for a Manager for Medical Writing services within our Regulatory writing team. If you are a Principal Medical writer looking for your first step into line management or an already experienced manager within regulatory writing then we are keen to hear from you.
This role can be a full remote role based in a number of our EMEA locations including Belgium, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Romania, Spain and the UK.
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.
This role would suit a principal medical writer who is looking for that first step into a line management role, with a business that offers a structured career path.
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.
Education:
- Bachelor's degree or higher in Life Sciences/Health Related Sciences or equivalent
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.
Apply today to begin your Parexel journey!
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