Senior Medical Writer

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Embedded within our FSP client, a fasr growing, dynamic Pharmaceutical company, you will be responsible for the development of clinical docs for worldwide submissions to regulatory authorities. This role can be based anywhere in Europe, homebased.

Job responsibilities

You will be responsible for the development of clinical documents for worldwide submissions to regulatory authorities. Works directly with multidisciplinary project team members with the goal of independently writing scientifically valid, complete, and consistent documents, such as clinical study reports (CSRs), investigator's brochures (IBs), and select clinical Module 2 summary documents - CTD's.

The Senior Medical Writer may be responsible for the medical writing activities for one or more compounds and may contribute to major submissions. Understands the clinical research processes and global regulatory document standards. Demonstrates strong interpersonal and organizational skills and can interpret and describe results. This position reports to the Head of Medical Writing.

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives.
• Actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines and any processes needed for the completion of regulatory documents.
• Administrate as appropriate, the receipt, collation, and incorporation of review comments needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
• Assist in defining and writing standard operating procedures and working practices to allow the effective and efficient preparation of quality documents.
• May participate in cross-functional process improvement initiatives.

#LI-NC1What we're looking for

• A Bachelor's degree in life science discipline with Master's degree in life science discipline preferred.
• Strong clinical medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical development.
• Understanding and knowledge of global regulatory requirements.
• Knowledge of the various phases of clinical development required.
• Proficiency in organizing and communicating clinical information required.
• Strong communication, organizational, time management, and project management skills are required.
• Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
• Strong experience of writing CTD's.
• Experience with an electronic document management system (eg, Documentum, Master Control) and templates is preferred.

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

#LI-NC1