Syneos Health/ inVentiv Health Commercial LLC
Principal Medical Writer - Regulatory Submission Documents
Syneos Health/ inVentiv Health Commercial LLC, Trenton, New Jersey, United States
Principal Medical Writer – Regulatory Submission Documents
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
Benefits
Company car or car allowance
Health benefits including Medical, Dental and Vision coverage
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions or bonus based on company and individual performance
Flexible paid time off (PTO) and sick time – note that eligibility for paid sick time may vary depending on location and local regulations
Salary Range $80,600 – $145,000
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.
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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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
Benefits
Company car or car allowance
Health benefits including Medical, Dental and Vision coverage
Company match 401k
Eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions or bonus based on company and individual performance
Flexible paid time off (PTO) and sick time – note that eligibility for paid sick time may vary depending on location and local regulations
Salary Range $80,600 – $145,000
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.
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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