[PW762] Senior/Principal Medical Writer (Regulatory experience required)

[PW762] Senior/Principal Medical Writer (Regulatory experience required)

07 nov
|
Syneos Health
|
España

07 nov

Syneos Health

España

JOB SUMMARY



Syneos Health is looking for a Senior/Principal Medical Writer to join our organization. This is a permanent and fully remote role and it is open across Europe. The role serves as a senior medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory while serving as primary technical contact with the internal team and the client.



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 comments on 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



QUALIFICATION REQUIREMENTS



- 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.

El anuncio original lo puedes encontrar en Kit Empleo:
https://www.kitempleo.es/empleo/19320917/pw762-senior-principal-medical-writer-regulatory-experience-required-espana/?utm_source=html

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