Parexel

Senior Medical Writer

Company
Parexel
Location
Czech Republic
Salary
Competitive
Posted
28 Jan 2021
Closes
27 Feb 2021
Ref
64390BR
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Job Description

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 Head Office situated in Uxbridge, Madrid or Dublin or be fullyhome-based anywhere in the UK, Ireland or Spain . The offices are open planned, and you will be working in an innovative and collaborative environment.

As the Senior Medical Writer youwill research, create, and edit all documents associated with clinical research. Responsibilities will 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.

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.

Document Project Management
- Act 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/SOPs. Distribute final documents to project team and client.

Training/ Compliance
- Attend and complete mandatory, corporate, project-specific, and departmental training as required.
- Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department.

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.Qualifications

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.
-Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy.

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.
-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.

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, as well as a benefits package including 25 days holiday per year, a strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover as well as other leading-edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey!Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.