Clinical Scientific Medical Writer
- Expired: over a month ago. Applications are no longer accepted.
Synterex, Inc. is a consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug and device development through post-approval. Synterex is seeking an organized, motivated, and collaborative individual for Clinical Scientific Medical Writer role.
As a Clinical Scientific Medical writer, you will provide the nonclinical primary pharmacology (NCP) components required for regulatory submissions, including summary documents and study reports. In close collaboration with research unit (RU) scientists, the colleague will author and/or quality review the NCP summaries required for submission level documents such as the Investigator Brochures (IB) and Investigational New Drug (IND) Applications, Clinical Trial Applications (CTA), New Drug Applications (NDA) or Biological Licensing Applications (BLA). You will represent NCP as the regulatory expert in crossline meetings for preparation of regulatory summary components (e.g., NCO, IND and IB reviews), ensure timely delivery of components, and ensure that NCP documentation is in compliance with regulatory requirements/guidelines (meeting the client’sw Global Style Guidelines) using appropriate document management tools.
Contract length: 12 months
Location: 100% Onsite Hybrid Role – Groton, CT
Must follow return to site policy
Essential Duties & Responsibilities:
- Prepare and deliver NCP components of submission documents (such as Briefing Documents, IND, IB, CTA, NDA, BLA etc.), working in partnership with biology project leads. Ensure appropriate information is included in these documents and that supporting, final documentation (study reports and data) is in place.
- Partner with lines such as PDM, DSRD, Clinical, and Regulatory, to ensure NCP document content is fit for purpose.
- Represent NCP on crossline regulatory document review meetings. Respond and integrate team review comments appropriately.
- Assist in the preparation and delivery of query responses.
- Conduct QC review of documents included in regulatory submissions.
- Understanding of relevance and impact of primary pharmacology studies in drug discovery and development.
- Degree in biology, pharmacology, or similar is desired
- Project management skills.
- Familiarity with scientific terminology and an aptitude for scientific writing.
- Strong attention to details and application of good scientific principles.
- Awareness of regulatory requirements, relevant ICH guidelines, and country-specific filing requirements.
- BS or BA Degree in biology, pharmacology, or similar is desired. MS would also be considered.
- Preferred 1-2 years’ experience working in a laboratory setting with publication experience or experience writing scientific summary documents.
- Experience with writing components, but focus is QC Review.
- Good understanding of regulatory submission process.
- Ability to meet set deliverables outlined by the team.
- Self-motivated individual with the ability to work independently and also collaborate with other teams and colleagues to collect necessary data.
- Science background experience needed along with knowledge to understand the information and ensure it is correct.
- Ability to verify the data and cross check with appropriate sources.
For further information or to apply, please reach out to firstname.lastname@example.org.
Synterex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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