Principal Medical Writer - Single Sponsor Dedicated - Submission Documents

Syneos Health; Milano; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A global biopharmaceutical solutions organization is seeking a Principal Medical Writer in Milan. The role involves mentoring less experienced writers, developing clinical documents, and ensuring adherence to regulatory standards. Candidates should have a Bachelor's degree in Science or Arts, strong English grammar knowledge, and effective communication skills. This role offers an opportunity to work in a dynamic environment that values diversity and employee development.

Servizi

Career development and progression

Supportive management

Diversity and inclusion initiatives

Competenze

• Relevant experience in medical writing or similar role.
• Understanding of FDA and ICH regulations preferred.
• Familiarity with clinical research principles.

Mansioni

• Mentor and lead less experienced medical writers.
• Develop and support various clinical documents.
• Adhere to regulatory standards and deliver projects on time.

Conoscenze

Strong knowledge of English grammar

Effective presentation skills

Proofreading skills

Interpersonal skills

Team-oriented approach

Formazione

Bachelor's degree in Science or Arts

Strumenti

Word

Excel

PowerPoint

Descrizione del lavoro

Principal Medical Writer - Single Sponsor Dedicated - Submission Documents

Description

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model places the customer and the patient at the center of everything we do. We continuously seek ways to simplify and streamline our work to make Syneos Health easier to work with and for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, 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 about changing 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, progression, supportive management, training, peer recognition, and rewards.
• We are committed to our Total Self culture, where you can be yourself. We focus on diversity and inclusion to create a sense of belonging.

Job Responsibilities

• Mentor and lead less experienced medical writers on complex projects.
• Represent the Medical Writing department on clinical study teams, at conferences, meetings, and client presentations.
• Advise clients and study teams on data presentation, production strategies, and quality standards.
• Develop and support various documents, including clinical protocols, reports, narratives, development plans, submissions, and publications.
• Review statistical analysis plans and specifications for content, grammar, and consistency.
• Provide peer reviews to ensure clarity, accuracy, relevance, and quality.
• Adhere to regulatory standards, SOPs, templates, and deliver projects on time and within budget.
• Perform literature searches and maintain professional development.
• Understand budget constraints and communicate effectively with leadership.
• Complete administrative tasks and perform other duties as assigned, with minimal travel required.

Qualifications

• Bachelor's degree in Science or Arts with relevant experience; preferred backgrounds include Social Sciences, English, or Communications.
• Strong knowledge of English grammar and AMA style guide.
• Understanding of FDA and ICH regulations is preferred.
• Effective presentation, proofreading, interpersonal skills, and a team-oriented approach.
• Proficiency in Word, Excel, PowerPoint, email, and Internet.
• Familiarity with clinical research principles and data interpretation skills.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all FDA-approved drugs, 95% of EMA-authorized products, and conducted over 200 studies across 73,000 sites and 675,000+ trial patients.

We encourage initiative and challenge the status quo in a dynamic environment. Learn more at http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities are not exhaustive. The company may assign other tasks as needed. Equivalent experience, skills, or education will be considered. This description does not constitute a contract. We comply with applicable legislation, including the EU Equality Directive and the Americans with Disabilities Act, providing accommodations when appropriate.