Syneos - Clinical and Corporate - Prod
Description
Senior Medical Writer
Syneos Health® is a leading in all aspects of health services in the bio-pharma solutions organisation which is designed to help clients reach their goals. We convert ideas generated through expertise in clinical, medical affairs and commercial practice to implement operative measures to meet the current business needs.
To meet this goal, our model of Clinical Development places the customer and the patient at the heart of everything we do. All the time, we explore solutions in order to optimize our processes not only for those who work with Syneos Health, but also for Syneos Health itself.
Whether you join us on a Functional Service Provider partnership or a Full-Service environment, you will be working in partnership with passionate problem solvers and will be part of innovative teams to help deliver the goals of our customers. We are quick and determined to expedite the shipment of the therapies because we are ready to offer a healthy life-changing intervention.
Hear what our 29000 associates from 110 countries already know: WORK HERE IS IMPORTANT TO THE WHOLE WORLD Why Syneos Health Complementary to that.
We are passionate when it comes to developing our people through career development and progression; supportive and engaging line management; medical and therapeutic area training; peer recognition and total rewards.
We are inspired to live our Total Self culture – a culture that allows people to be themselves without any limitations and fully. Our Total Culture approach remains our bonding factor and we are ready to shield our employees and why not ourselves.
We are constantly developing the company that all of us would gladly go to work for and which our clients would love to work with. Why? Because we live assuming that differences of thoughts, races, culture and even outlook will be brought together, a platform where every individual feels that he or she is a part of.
Subordinate tasks
Provides guidance and leads other writers, especially those that are less experienced in writing for medical purposes and clinical researches if required and working on complicated issues.
Takes responsibility for the lead of specific writing tasks/projects.
Conducts medical writing tasks for individual studies and works with or coordinates medical writing tasks across and between departments without supervision within non-complex studies.
Creates or helps to create a helping variety of documents like-
Clinical study protocols and its amendments;
Clinical study reports;
Report of the individual patient;
Clinical development plans;
Applications and annual reports for investigational new drug;
Reports providing integrated summaries;
Reports for drug approval applications and e-CTD submissions;
Brochures for clinical trial investigators, e.g. and.
Clinical journal articles, clinical journal articles abstracts and client folder presentations.
Copy
Makes suggestions and helps in resolving problems and questions emergent in the writing process, including making decisions as to escalate or not.
Reviews the statistical analysis plans as well as the specification of tables from different publications list and the figures for the subject matter reviewing, grammar checking, formatting and consistency.
Collaborates with department’s head and other staff members especially those involved in data management, biostatistics, regulatory affairs and medical affairs to the extent necessary in order to make writing deliverables.
Acts as a reviewer on internal review team and gives comments about the draft and final products.
Fulfills medical writing assignments in compliance with regulatory requirements including but not limited to ICH-E3 guidelines and Company Standard Operating Procedures and templates that are in limited use without infringing on the project scope and timeline.
Conducts searches of clinical literature on the internet, when appropriate.
Keeps abreast of new developments concerning medical writing practice and regulatory and other guidelines that affect this scope of activity.
Keeps track of budget limitations allocated for certain projects and adjusts working time within the defined budget limits and gives appropriate notice to medical writing management.
Meets the deadlines and completes all the administrated required tasks within the stipulated time.
Other job-related duties assigned by supervisor. Some travel, less than 25%, may be required OR less than 25% travel may be required.
Qualifications
What we are looking.
Bachelor of science or arts, the writing has adequate relevance or Bachelor of Arts which is preferably Social Science, English or Communications, with adequate relevant scientific and/or clinical knowledge and expertise.
Copy
Sound understanding of the English language in terms of grammar rules as well as knowledge of the FDA and ICH policies and guidelines and some knowledge of AMA style guide.
Ability to work well independently and in addition possess good presentation, proofreading, interpersonal and leadership abilities and contribute to nightmare oriented teamwork.
Word, excel, powerpoint, email, internet.
Good knowledge of the aspects of clinical research and experience in clinical data interpretation and expression of complex information.
Syneos Health has worked with 94% of all Novel FDA Approved Drugs including but not limited to 95% of EMA Authorized Products and over 200 Studies across 73000 Sites and 675000 + Trial patients in the past 5 years.
You do not have to worry about what your role is, as all of you will have the opportunity to take ownership and upend the business with us in an incredibly fast-moving and highly competitive environment. Get more information on Syneos Health.
Additional information: Tasks, duties, and responsibilities as listed in this job description are not inclusive . The Company, at its own discretion and without any notice, may assign any other necessary tasks, duties, and obligations. In any case, as there are factors such as pertinent work experience and skill, it may be different from what is in the job advertisement. It is understood that based on its sole discretion, the Company may decide what is equivalent to the qualifications mentioned above. Also nothing contained in this document seems to be intended for the creation of employment. More often than not, job requirements may include special qualifications / experiences in short phrases. This sale document is intended to cover all legal requirements of every nation Territorial OA clinic covers including that of implementation of the EU Equality Directive in relation to the holding and hiring of its employees which may be embodied in these provisions. The Company will uphold the provisions of the Americans with Disabilities Act and will provide reasonable accommodation to manage able employees or applicants to perform the essential functions of the position when appropriate.