Principal Medical Writer

Principal Medical Writer

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 places the customer and the patient at the center of everything we do. We continuously look for ways to simplify and streamline our work to make Syneos Health easier to work with and 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 reach their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

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. This culture unites us globally, and we are dedicated to caring for our people.
• We are continuously building the company we want to work for and the customers want to work with. When we bring together diverse thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels 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, and reports such as 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 e
  CTD submissions, journal manuscripts, abstracts, posters, and presentations for scientific meetings.
• Adhere to established regulatory standards, including ICH E3 guidelines, company SOPs, 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.
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices.
• Experience writing relevant document types.
• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with the 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.

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 will determine what constitutes as equivalent to the qualifications described above. Nothing contained herein should be construed to create an employment contract. The Company complies 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 recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, and will provide reasonable accommodations as appropriate.

Summary

Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for
- company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare
- based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and 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 e
CTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They 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. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency and proper format.

Core Focus

• Leading the clear and accurate completion of medical writing deliverables
• Managing medical writing activities associated with individual studies
• Coordinating these activities within and across departments
• Completing a variety of documents, adhering to established regulatory standards
• Coordinating quality and editorial reviews
• Acting as peer reviewers for the internal team
• Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency
• Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs
• Performing online clinical literature searches and complying with copyright requirements
• Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff
• Mentoring and leading less experienced medical writers on complex projects
• Developing deep expertise on key topics in the industry and regulatory requirements
• Working within budget specifications for assigned projects

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Marketing, Public Relations, and Writing/Editing

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