Postgraduate degree in Life Sciences, preferably M.Pharm or PharmD., Experience in Clinical Trial Disclosure and Regulatory Medical Writing., Familiarity with Pharmacovigilance and Safety Narrative Writing., Preferred experience with regulatory bodies like US FDA and ClinicalTrials.gov..
Key responsibilities:
Compile, write, and edit medical writing deliverables with moderate supervision.
Develop a variety of documents including clinical study protocols and reports.
Review statistical analysis plans for content accuracy and consistency.
Interact with various departments to produce writing deliverables and adhere to regulatory standards.
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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.
We bring together a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics.
Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.
Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.
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
Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision.
Develops or supports, a variety of documents that include but not limited to:
Clinical study protocols and clinical study protocol amendments;
Clinical study reports;
Patient narratives;
Investigator brochures.
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.
Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
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.
Continues professional development to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills.
Is 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 timeframes.
Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).
Qualifications
What we’re looking for
Any Life Science postgraduate-Prefer M.Pharm,PharmD
Candidates having experience in Clinical Trial Disclosure, Regulatory Medical Writing, Pharmacovigilance (Safety Narrative Writing).
Responsibilities include drafting CTD documents for clients and performing quality checks (QC) documents
Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EUCTR
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
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.
Required profile
Experience
Spoken language(s):
English
Check out the description to know which languages are mandatory.