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Senior Medical Writer
hace 2 meses
We are seeking a highly skilled Principal Medical Writer to join our team at Syneos Health. As a key member of our IAI Medical Writing Team, you will be responsible for developing clinical documents for submissions to regulatory authorities globally.
Your primary focus will be on writing scientifically valid, complete, and consistent documents such as clinical study protocols and amendments, clinical study reports (CSRs), Investigator's Brochures (IBs), clinical Module 2 summary documents, and other regulatory documents.
You will work closely with multidisciplinary project team members to ensure that all documents meet the highest standards of quality and accuracy.
In this role, you will have the opportunity to lead the submission process and work on strategic parts of the submission.
Key Responsibilities
* Develop clinical documents for submissions to regulatory authorities globally
* Work with multidisciplinary project team members to ensure high-quality documents
* Lead the submission process and work on strategic parts of the submission
* Collaborate with team members to ensure consistency and accuracy in documents
Requirements
* 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
* Understanding of FDA and ICH regulations and guidelines strongly preferred
* Demonstrated effective presentation, proofreading, and interpersonal skills and ensure a team-oriented approach
* Previous writing experience in the following docs - clinical study protocols and amendments, clinical study reports (CSRs), Investigator's Brochures (IBs), clinical Module 2 summary documents, and other regulatory documents
* Strong proficiency in Word, Excel, PowerPoint, email, and Internet
* Must have been a Senior Medical Writer in a CRO or Pharmaceutical company working within a clinical writing role
* Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information
About Syneos Health
At 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.
What We Offer
* Career development and progression opportunities
* Supportive and engaged line management
* Technical and therapeutic area training
* Peer recognition and total rewards program
* Total Self culture - where you can authentically be yourself
* Diversity of thoughts, backgrounds, cultures, and perspectives
How to Apply
If you are a motivated and experienced Principal Medical Writer looking for a new challenge, please submit your application.
We look forward to hearing from you
