2 Empregos para Novartis - Brasil

Sr Medical Writer (Must Have - Drug Development & Late Phase Exp)

Syneos Health

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Sr Medical Writer (Must Have - Drug Development & Late Phase Exp)

Join to apply for the Sr Medical Writer (Must Have - Drug Development & Late Phase Exp) role at Syneos Health

Overview

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 collaborate to simplify and streamline work across Functional Service Provider partnerships or Full-Service environments. We are agile and driven to accelerate the delivery of therapies and change lives.

WORK HERE MATTERS EVERYWHERE

Job Responsibilities
  • Mentor and lead less experienced medical writers on complex projects as necessary.
  • Act as lead for assigned writing projects.
  • Manage medical writing activities for individual studies, coordinating activities across departments with minimal supervision. Develop or support documents including clinical study protocols and amendments; clinical study reports; patient narratives; clinical development plans; IND submissions and annual reports; integrated summary reports; NDA and (e)CTD submissions; investigator brochures; clinical journal manuscripts and abstracts; client presentations.
  • Identify and propose solutions to resolve issues during the writing process, including escalation as appropriate.
  • Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
  • Interact with department heads and staff in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
  • Serve as peer reviewer on internal review teams, providing comments on drafts and final documents.
  • Adhere to regulatory standards (including ICH-E3), SOPs, client standards, and approved templates; deliver projects on time and on budget.
  • Perform online clinical literature searches as applicable.
  • Maintain familiarity with current industry practices and regulatory guidelines affecting medical writing.
  • Maintain awareness of budget specifications for assigned projects, working within budgeted hours and communicating changes to medical writing leadership.
  • Complete required administrative tasks within specified timeframes.
  • Perform other duties as assigned. Minimal travel may be required (less than 25%).
Qualifications
  • Bachelor of Science in a relevant field or Bachelor of Arts (Social Sciences, English or Communications) with relevant scientific/medical knowledge.
  • Extensive knowledge of English grammar and FDA/ICH regulations and guidelines; familiarity with AMA style guide.
  • Demonstrated independence with strong presentation, proofreading, interpersonal, and leadership skills; team-oriented approach.
  • Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
  • Ability to interpret and present clinical data and other complex information.
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 your role, you’ll take the initiative and challenge the status quo in a dynamic environment. Learn more at .

Additional Information
  • Tasks, duties, and responsibilities are not exhaustive. The company may assign other tasks at its discretion. Equivalency of experience/skills will be considered. Nothing herein creates an employment contract.
  • Compliance with applicable laws, including the EU Equality Directive and the Americans with Disabilities Act, with reasonable accommodations when appropriate.
Summary

Strong medical writing skills with lead-authoring experience on various drug regulatory documents. Ability to manage multiple deliverables in parallel while maintaining quality and meeting timelines. Opportunities for growth in a global team environment.

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Marketing, Public Relations, and Writing/Editing
Industries
  • Biotechnology Research
  • Pharmaceutical Manufacturing
  • Research Services

Referrals increase your chances of interviewing at Syneos Health. Get notified about new Senior Medical Writer jobs in Brazil .

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Sr Medical Writer (Must Have - Drug Development & Late Phase Exp)

São Paulo, São Paulo Syneos Health, Inc.

Publicado há 10 dias atrás

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Descrição Do Trabalho

Sr Medical Writer (Must Have - Drug Development & Late Phase Exp)

Description

Sr Medical Writer (Must Have - Drug Development & Late Phase Exp)

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

- Mentors and leads less experienced medical writers on complex projects, as necessary.

- Acts as lead for assigned writing projects.

- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. -Develops or supports a variety of documents that include, but not limited to:

- Clinical study protocols and clinical protocol amendments;

- Clinical study reports;

- Patient narratives;

- Clinical development plans;

- IND submissions and annual reports;

- Integrated summary reports;

- NDA and (e)CTD submissions;

- Investigator brochures, as well as;

- Clinical journal manuscripts, clinical journal abstracts, and client presentations.

- Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.

- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.

- Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.

- Serves as peer reviewer on internal review team providing review commentson draft and final documents.

- 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 when completing medical writing projects, on-time and on-budget.

- Performs on-line clinical literature searches, as applicable.

- Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.

- Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.

- Completes required administrated tasks within the specified timeframes.

- Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).

Qualifications

- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.

- Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.

- Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.

- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.

- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

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.

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.

Summary

Strong medical writing skills and experience in lead authoring various drug regulatory documents. Ability to lead and work on multiple deliverables in parallel whilst maintaining quality and meeting agreed timelines/milestones. Opportunity to work in a fantastic global team environment and ample opportunities for growth and development.

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

Syneos Health (Nasdaq:SYNH) 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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.

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