Principal Medical Writer - Regulatory Submission Documents

Principal Medical Writer - Regulatory Submission Documents

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

• Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision.
• Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, 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.
• Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides.
• Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately.
• Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format.
• Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs.
• Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
• Perform online clinical literature searches and comply with copyright requirements.
• Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff.
• Mentor and lead less experienced medical writers on complex projects.
• Develop deep expertise on key topics in the industry and regulatory requirements.
• Work within budget specifications for assigned projects.

Qualifications

• Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred.
• 3-5 years of relevant experience in science, technical, or medical writing.
• Experience working in the biopharmaceutical, device, or contract research organization industry required.
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required.
• Experience writing relevant document types required.
• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style.

Necessary Skills

• Strong presentation, proofreading, collaborative, and interpersonal skills.
• Strong project and time management skills.
• Strong proficiency in MS Office.
• Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information.

Salary Range

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

$95,000.00 - $175,700.00

About 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

Key skills/competency

• Medical Writing
• Regulatory Submissions
• ICH Guidelines
• Clinical Study Protocols
• eCTD Submissions
• Patient Narratives
• Quality Control
• Data Interpretation
• Project Management
• Client Relationship Management