Principal Medical Writer - Regulatory Medical Writing docs

Principal Medical Writer ( Regulatory Medical Writing docs)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
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 deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

5+ years of Regulatory Medical Writing experience with expertise in authoring Protocols, Protocol Amendments, CSRs, Narratives, PSURs, DSURs, ICFs, and IBs.
Proven Lead Medical Writer experience, independently managing end-to-end document development in a CRO environment while partnering with pharmaceutical companies.

• Leads the clear and accurate completion of complex medical writing deliverables, ensuring

scientific information is presented clearly and accurately. Manages medical writing activities

associated with individual studies, defining document strategy and coordinating medical writing

activities within and across departments with minimal supervision. Leads the resolution of

comments from the client.

• Completes a variety of documents that may include clinical study protocols and clinical study

protocol amendments; clinical study reports; patient narratives; annual reports; investigator

brochures; informed consents; annual reports; plain language summaries; periodic safety update

reports, clinical development plans; IND submissions; integrated summary reports; NDA and

eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific

meetings.

• 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, authorship requirements, and style and formatting guides, when completing

medical writing projects, on time and on budget.

• Advises clients and study teams on data presentation and production strategies to ensure that

client objectives/expectations are met and quality standards are maintained.

• Leads team document reviews and reviews documents for technical issues. Coordinates quality

and editorial reviews and ensures source documentation is managed appropriately.

• Serves as expert peer reviewer for internal team, providing review comments to give maximum

clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and

overall quality standards are maintained.

• 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 and document needs.

• Interacts and builds good working relationships with clients, department head, and team members

in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to

produce writing deliverables. Works with staff across company to advance company priorities.

• Performs online clinical literature searches and complies with copyright requirements.

• Identifies and proposes solutions to resolve issues, escalating as appropriate. Serves as a key

technical SME and contributes to development of internal materials and presentations on needed

topics. Contributes to changes to internal process, standard practices, and capabilities.

• Mentors and leads less experienced medical writers on complex documents.

• Develops deep expertise on key topics in the industry and the regulatory requirements and

guidelines that affect medical writing. Engages externally with industry groups on industry

initiatives.

• Aware of budget specifications for assigned projects, communicating status and changes to

medical writing leadership. Contributes to bid projections.

• Communicates status and changes to medical writing leadership; negotiates timelines and

assigned deliverables.

• Represents the medical writing department on clinical study teams, at conferences, meetings, and

for presentations to the client regarding writing projects.

• Completes required administrative tasks within the specified timeframes.

• Performs other work-related duties as assigned.

• Minimal travel may be required (less than 25%).

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.

http://www.syneoshealth.com

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.