ADSr Principal Medical Writer Remote in US
ADSr Principal Medical Writer Remote in US
Posted on :
03-02-2025
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1 Vacancy
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Job Description
Job Title: AD/Sr Principal Medical Writer (Must have led submissions process) Remote in US
Job Location: Leeds UK
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Description
Senior Principal Medical Writer
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 FullService 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 29000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
What we’re looking for
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 73000 Sites and 675000 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 everchanging 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.
Senior Principal Medical Writer
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 FullService 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 29000 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.
- The Associate Director Principal Medical Writer II is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to crossfunctional project teams with minimal oversight to ensure that clinical documents (eg Investigators' Brochures IBs Clinical Study Reports CSRs and marketing authorization submission documents) accurately and consistently present key datadriven clinical messages in accordance with program goals and regulatory requirements.
- Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous logically organized and have accurate data presentation and interpretation.
- Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents.
- Has a broad understanding of clinical research processes and global regulatory document standards. Mentors less experienced writers. Reports to a Director of Medical Writing or above.
- Provides support training and consultation to department and other company employees as needed.
- Serves as a subject matter expert and contributes to the development of training materials and presentations on key topics where appropriate.
- Mentors and leads less experienced medical writers on complex projects as necessary.
- Represents the Medical Writing department on clinical study teams at conferences meetings and for presentations to the client regarding a writing project.
- Advises clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained.
- Develops good working relationships with internal and external colleagues.
- Lead manage and coordinate all internal and external clinical medical writing activities associated with the preparation compilation and submission of applications to regulatory authorities globally for the assigned programs/compounds.
- 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.
What we’re looking for
- 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. Extensive knowledge of English grammar with a familiarity with AMA style guide.
- Must have led managed and coordinate all internal and external clinical medical writing activities associated with the preparation compilation and submission of applications to regulatory authorities globally for the assigned programs/compounds.
- We are looking for an experienced person to be the Medical Writing submission lead for one of our client's oncology programs to coordinate all planning and oversight of medical writing activities. Experience being the medical writing lead for submissions (NDA BLA MAA etc); writing clinical summary documents (2.7.3/ISE 2.7.4/ISS Clinical Overview) CSRs briefing books and responses; and experience in oncology is required. The person can be based in the US or Europe.
- 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.
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 73000 Sites and 675000 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 everchanging 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.
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Employment Type
Full Time
Key Skills
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