Senior Medical Writer - Regulatory Documents - CSR /Protocol - Late Phase

Senior Medical Writer - Regulatory Documents - CSR Protocol - Late Phase

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 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.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you will 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 are able to create a place where everyone feels like they belong.

Job Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Leads the resolution of comments from the client.
• Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, annual reports, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including but not limited to ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved templates, authorship requirements, and style and formatting guides when completing medical writing projects on time and on budget.
• Coordinates quality and editorial reviews, ensuring source documentation is managed appropriately.
• Leads team document reviews and reviews documents as needed.
• Acts as peer reviewer for internal team to ensure document scientific content clarity, overall consistency, and proper format.
• Reviews statistical analysis plans and table/figure listing specifications for appropriate content and for grammar, format, and consistency.
• Provides feedback to further define statistical output required and document needs.
• Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
• Performs online clinical literature searches and complies with copyright requirements.
• Identifies and proposes solutions to resolve issues escalating as appropriate.
• Provides technical support, training, and consultation to department and other company staff.
• May contribute to development of internal materials and presentations or changes to internal process standard practices and capabilities.
• Mentors and leads less experienced medical writers on complex projects as necessary.
• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.
• Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership.
• Completes required administrative tasks within the specified timeframes.
• Performs other work-related duties as assigned.

Benefits

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop, and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include:

• Company car or car allowance
• Health benefits, including medical, dental, and vision
• Company match 401k eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions and bonuses based on company and individual performance
• Flexible paid time off (PTO) and sick time

Salary Range

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors, such as the candidates qualifications, skills, competencies, and proficiency for the role.

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 will take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health: http://www.syneoshealth.com

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 and 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.

Summary

We are looking for a Senior Medical Writer with strong expertise in late Phase Protocol and CSR writing. Experience with authoring of additional documents, such as NDA, IND, IB, DSUR, RMP, Briefing Package, and Response documents, amongst others, is also taken into consideration. Apply for this job: Not ready to apply? Join our Talent Network.

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We work hard and smart all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients lives around the world. Selecting us as an employer secures a career in which you are guaranteed to:

• Collaborate with passionate problem solvers
• Partner with the most diverse team of experts in the industry
• From the top down, our people are inspiring
• Everyone has a voice and is encouraged to use it
• Be empowered and thrive
• Heres no shortage of challenging work, learning, and opportunities
• Evolve in a growing global company that is always looking for ways to work smarter and more efficiently
• Over deliver and out-perform
• Challenge the status quo in a highly competitive and ever-changing environment
• Be agile and take initiative to find new solutions reflective of the high-quality standards we and our customers expect
• Help change lives
• We take our work seriously
• Each day you will contribute to improving patients lives around the world by shortening the distance from lab to life
• Its powerful and fulfilling work of which you can be proud

Get in Touch

Syneos Health Nasdaq SYNH 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. Together, we share insights, use the latest technologies, and apply advanced business practices to speed our customers delivery of important therapies to patients. We support a diverse, equitable, and inclusive culture.

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