Single Sponsor Senior Clinical Medical Writer - (fully home based) 6 month FTC, Tottenham, England, United Kingdom

Single Sponsor Senior Clinical Medical Writer - (fully home based) 6 month FTC

18 Days Old

Single Sponsor Senior Clinical Medical Writer - (fully home based) 6 month FTC

6 days ago Be among the first 25 applicants

Description

Single Sponsor Senior Clinical Medical Writer - (fully home based) 6 month FTC

Description

Single Sponsor Senior Clinical Medical Writer - (fully home based) 6 month FTC

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

Acts as lead for assigned writing projects.
Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
Develops or supports a variety of documents that include, but not limited to:
Clinical study protocols and clinical protocol amendments;
Clinical study reports;
Patient narratives;
Clinical development plans;
IND submissions and annual reports;
Integrated summary reports;
NDA and (e)CTD submissions;
Investigator brochures, as well as;
Clinical journal manuscripts, clinical journal abstracts, and client presentations.
Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
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 providing review comments on draft and final documents.
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.
Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
Maintains awareness 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 timeframes.
Performs other work-related duties as assigned.

Qualifications

Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
Previous experience as a Senior Medical Writer working in a CRO or Pharma. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
Needs experience writing clinical and submission ready documents.
Oncology / Auto-immune diseases exp.

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 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/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.

Seniority level

Seniority level
Mid-Senior level

Employment type

Employment type
Full-time

Job function

Job function
Business Development and Sales
Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Research Services

Referrals increase your chances of interviewing at Syneos Health by 2x

Get notified about new Sponsor jobs in Tottenham, England, United Kingdom.

London, England, United Kingdom 1 month ago

London, England, United Kingdom 11 hours ago

London, England, United Kingdom 6 months ago

London, England, United Kingdom 1 week ago

Project Engineering Manager – IoT and Smart Data

London, England, United Kingdom 2 weeks ago

Remote Travel Agent - Work From Home Opportunity

London, England, United Kingdom 1 month ago

Territory Sales Manager – London East & Home Counties

Greater London, England, United Kingdom 5 days ago

London, England, United Kingdom 6 days ago

London, England, United Kingdom 4 days ago

London, England, United Kingdom 1 month ago

Senior Credit Analyst, Personal Borrowing

London, England, United Kingdom 3 days ago

London, England, United Kingdom 4 days ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr

Apply

Location:: Tottenham, England, United Kingdom
Salary:: £80,000 - £100,000
Job Type:: FullTime
Category:: Bio & Pharmacology & Health

Start a New Search