Job Description

Updated: Yesterday
Location: United Kingdom, United Kingdom
Job ID: 23001446

Description

Senior Director, Medical Writing

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. You\'ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• 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.

Job responsibilities

We are seeking a Senior Director, Medical Writing to lead our team across Europe. This role will provide scientific, leadership and operational expertise and be a key part of the functional leadership team. Key responsibilities will include:

• Providing oversight for the Medical Writing team in Europe; including line management for staff members and other associated tasks
• Overall responsibility for planning, implementing and adhering to medical writing budgets.
• Building and maintaining relationships with internal and external customers - playing a key role in business development-related activities and attending client meetings, writing and reviewing proposals, pricing deliverables, attending bid defense meetings, and contributing to contracts and work orders.
• Developing and reviewing financial forecasts, and monitoring revenue, costs & utilization. Providing regular business updates to senior leaders.
• Driving and promoting organisational process improvement initiatives, and creating an environment across the team that encourages others to initiate process improvements
• Collaborate cross-functionally with internal colleagues to improve quality and efficiency across projects and across the organization.
• Oversee medical writing programs and preferred provider relationships, as needed.
• Developing and participating in department training
• Performing senior reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings, as needed.
• Review, approve, create, and revise standard operating procedures (SOPs), as appropriate.
• Participate in department and/or corporate planning, strategy, budget, profit/loss, and/or development activities.
• Participate in capacity planning, productivity goals, setting departmental- and staff-level expectations; supports the implementation of process changes needed, as applicable.
• Minimal travel may be required (up to 25%).

Qualifications

What we\'re looking for

• Bachelor\'s degree required with relevant scientific and/or medical knowledge and expertise.
• Extensive experience in medical writing with progressive management experience and experience in a contract research organization or pharmaceutical/medical device company.
• Extensive supervisory/ leadership experience required within medical writing/ regulatory environment.
• Extensive knowledge of English grammar required.
• Thorough knowledge of principles of clinical research, including FDA, EU, ICH regulations and guidelines and ISO standards; excellent communication skills.
• Highly effective presentation, interpersonal, and leadership skills with a team-oriented approach.
• Strong working knowledge of Microsoft Office

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you\'ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about

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 . 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.

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