Medical Writer II; Clinical Trial Transparency

Position: Medical Writer II (Clinical Trial Transparency)
Description

Medical Writer II (Clinical Trial Transparency)

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'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

1 to 3 years of experience in Disclosure.
Knowledge of Clinical Research, Clinical Trial, clinical registries (CT.gov, CTIS
- Clinical Trial information System, EUDRACT).
Experience in clinical registries, clinical trial Disclosure is mandatory.
Experience in databases like Pharma CM/ Disclose.
Good understanding of protocol registration process.
Fine with candidate with combination of redaction Disclosure.
Mentors less experienced medical writers on projects, as necessary.
Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision.
Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures.
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.
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 when completing medical writing projects, on-time and on-budget.
Performs on-line clinical literature searches, as applicable.
Working knowledge of drug development process and regulatory guidelines.
Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing.
Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.
Completes required administrated tasks within the specified time frames.
Performs other work-related duties as assigned.
Minimal travel may be required (less than 25%).

Qualifications:

Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred.
Client interaction experience.
Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
Experience writing relevant document types required
Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style

Necessary

Skills:

Strong presentation, proofreading, collaborative, and interpersonal skills
Strong project and time management skills
Strong proficiency in MS Office
Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information

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…