Medical Writer (Remote) Job

MEDICAL WRITER needed for a CONTRACT opportunity with Yoh's client. This position is REMOTE BASED.

WHAT YOU'LL BE DOING:

- Create and manage creation by others of any type of clinical regulatory document (eg, protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format.
- Independent, proactive, very experienced medical writer with demonstrated leadership in preparing multiple key summary submission documents (ie, Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview) for the CTD and demonstrated experience managing the project work of other medical writers.
- Ensures the quality, compliance with internal and external standards, and timely and efficient production of English-language clinical documents using an electronic document management system.
- Contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of registration dossiers
- Managing document completion when working on teams in which some members are new to the company or role, and are not familiar with expectations, roles or company procedures.
- This requires the MW to analyze and quickly understand the underlying issues, and to be able to build and consult a network of contacts (team members, clinical documentation colleagues, managers) so as to ensure the necessary support, training and information can be provided.
- Managing completion of high-quality documents on time when deliverables are late, incomplete, or of poor quality.
- Have and share a clear vision of the document strategy, timelines and associated challenges so as to ensure a common awareness across the team and an understanding of the impact when deliverables are not provided appropriately.
- Able to anticipate issues, develop back-up plans and risk mitigation strategies and ensure that clear lines of communication are established within a given document or project team, and with management as needed, so as to ensure that issues are addressed proactively as much as possible.

YOU NEED TO BRING TO THE TABLE:

- Substantial experience (eight to ten years) as a medical writer, or equivalent, and presenting relevant specialist qualifications (eg, Ph.D. in life sciences).
- Experience leading teams to prepare clinical regulatory submission documents, including CTD Module 2 summaries.
- Demonstrated experience mentoring and managing the project work of other medical writers.
- Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
- Detailed knowledge of requirements for preparation of key clinical regulatory documents (eg, CSRs and CTDs.)
- Accurate and detail-oriented with excellent inter-personal skills.
- English speaker or have proven excellent spoken and written English.
- Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system.
- Ability to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

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