*/Senior Medical Writer, Regulatory – Client-dedicated/*
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: toimprove health. You will be joining a truly collaborative and winning cultureas we strive to bend the time and cost curve of delivering life-saving therapies to patients.
PPD has an exciting opportunity for a *Senior Medical Writer* to join us onsite exclusively for one of our strategic partners in Belgium. PPD works in collaboration with this pharmaceutical partner and you will be dedicated to the client projects, processes, working within their teams and systems on behalf of PPD.
Home based positions may be available, however travel to the client office in Belgium may be required on a regulatory basis.
As a Senior Medical Writer, you will be responsible for:
* Preparing documents in support of clinical trials and assisting Regulatory Affairs professionals with marketing applications, INDs, pediatric investigational plans, clinical trial applications
* Writing and editing a variety of medical documents, including clinical study report, clinical protocols, informed consent forms, narratives, investigator brochures
* Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes.
Ideally, you will have:
* Education to Bachelor’s/advanced degree level in a scientific discipline
* 3 years of experience within regulatory medical writing
* Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities
Knowledge, Skills, and Experience:
* Must possess excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
* Must possess the ability to manage large projects with minimal supervision
* Must possess strong interpersonal, decision making, negotiation, and problem-solving skills
* Must possess exceptional oral and written communication skills with strong presentation skills
* Must possess significant knowledge of global, regional, national and other document development guidelines
* Must demonstrate excellent computer skills and be skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
– We have a strong will to win – We earn our customer’s trust – We are gamechangers – We do the right thing -We are one PPD –
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.
**Job:** **Medical Writing*
**Title:** *Senior Medical Writer, Regulatory – Client-dedicated*
**Requisition ID:** *169388*
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group