Senior Medical Writer – Regulatory Focus

🕒 il y a 2 mois

🌐 États-Unis, Canada – Distant

🇺🇸 États-Unis – Télétravail 🇨🇦 Canada – Télétravail

💵 $80 600 - $175 700 / an

⏰ Temps Plein

🟠 Senior

🏥📝 Rédacteur Médical

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 29%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Syneos Health

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10 000+ employés

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Syneos Health est une organisation de solutions biopharmaceutiques entièrement intégrée et leader, conçue pour accélérer le succès des clients. Ils transforment des intuitions cliniques, des affaires médicales et commerciales uniques en résultats pour répondre aux réalités du marché moderne. En utilisant des technologies avancées et des perspectives, Syneos Health collabore avec les clients pour accélérer la livraison de thérapies importantes aux patients dans le monde entier, offrant des services qui couvrent tout le spectre du clinique au commercial.

Description

• Lead the clear and accurate completion of medical writing deliverables • Manage medical writing activities associated with individual studies and coordinate activities across departments • Lead resolution of client comments • Complete clinical study protocols, protocol amendments, clinical study 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, abstracts, posters, and presentations • Follow ICH E3 guidelines, company standard operating procedures, client standards, approved templates, authorship requirements, and style and formatting guides • Coordinate quality and editorial reviews and manage source documentation • Lead team document reviews and review documents as needed • Act as peer reviewer for internal teams • Review statistical analysis plans and table/figure/listing specifications • Interact with clients and colleagues in data management, biostatistics, regulatory affairs, and medical affairs • Perform online clinical literature searches and comply with copyright requirements • Identify and propose solutions, escalating issues as appropriate • Provide technical support, training, and consultation • Contribute to internal materials, presentations, processes, standard practices, and capabilities • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements affecting medical writing • Work within budgeted hours and communicate status and changes to medical writing leadership • Complete required administrative tasks • Perform other assigned work-related duties • Minimal travel may be required, less than 25%

🎯 Exigences

• Minimum of 5 years of lead regulatory writing experience • Lead writing experience with Phase 2 and Phase 3 studies • Lead writer experience with protocols • Lead writer experience with submissions • Lead writer experience with clinical Summary of Safety (CTD) Modules 2.7.3 and 2.7.4 • Lead writer experience with CSRs (Clinical Study Reports) • Lead writer experience with IBs (Investigator Brochure) • Lead writer experience with Patient Narratives • Experience with Safety Aggregate Reports is a plus • Lead writer experience with Briefing Books • Lead writer experience with ISE and ISS (Integrated Summary Efficacy and Integrated Summary Safety) • Strong project management skills • Strong client experience • Strong time management skills • Process experience is a plus • Equivalent experience, skills, and/or education will also be considered

🏖️ Avantages

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive workplace culture • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time • Reasonable accommodations when appropriate

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