Overview
Principal Medical Writer at Syneos Health. Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient, and we strive to simplify and streamline our work to be easier to work with for both clients and colleagues. Whether you join in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with problem solvers to help customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. We believe work here matters everywhere.
Salary range information and benefits are provided below. This role includes the potential for a company car or car allowance, health benefits, 401(k) company match, eligibility for an Employee Stock Purchase Plan, possible commissions/bonus, and flexible PTO and sick time in accordance with applicable laws.
Responsibilities
- Mentor and lead less experienced medical writers on complex projects when necessary.
- Represent the Medical Writing department on clinical study teams, at conferences, meetings, and for client presentations regarding writing projects.
- Advise clients and study teams on data presentation and production strategies to meet client objectives, ensure quality standards, and maintain accuracy.
- Develop good working relationships with internal and external colleagues.
- Manage medical writing activities for individual studies, coordinating activities within and across departments with minimal supervision.
- Develop or support a variety of documents, including clinical study protocols and amendments, clinical study reports, patient narratives, clinical development plans, IND submissions and annual reports, integrated summaries, NDA/eCTD submissions, investigator brochures, and clinical journal manuscripts, abstracts, and client presentations.
- Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
- Provide peer review to ensure clarity, accuracy, relevance, and alignment with client objectives and quality standards.
- Adhere to regulatory standards (including ICH-E3), SOPs, client standards, and approved templates; complete projects on time and within budget.
- Perform online clinical literature searches as applicable.
- Pursue ongoing professional development to stay current with regulatory guidance and client expectations affecting medical writing.
- Understand budget specifications for assigned projects and communicate changes to medical writing leadership.
- Complete required administrative tasks within specified timeframes and may travel (not allowed in this refined version);
- Perform other duties as assigned.
Qualifications
- Bachelor of Science with relevant writing experience, or Bachelor of Arts (Social Sciences, English, or Communications preferred) with relevant scientific/medical knowledge.
- Extensive knowledge of English grammar with familiarity of AMA style guide.
- Understanding of FDA and ICH regulations and guidelines (strongly preferred).
- Demonstrated effective presentation, proofreading, and interpersonal skills with a team-oriented approach.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Ability to interpret and present clinical data and other complex information.
About Syneos Health
We are committed to developing our people through career development and progression, training, peer recognition, and total rewards. We foster a Total Self culture where everyone can be authentic and belong. Diversity of thought, background, culture, and perspectives helps us deliver for our customers.
Salary Range
$95,000.00 - $175,700.00
Additional Information
Tasks, duties, and responsibilities listed are not exhaustive. The Company may assign other tasks at its discretion. The Company may consider equivalent experience, skills, or education. Nothing herein should be construed as a contract. The Company complies with applicable paid sick time requirements where applicable. This position may require limited travel.
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Marketing, Public Relations, and Writing/Editing
Industries
- Biotechnology Research
- Pharmaceutical Manufacturing
- Research Services
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