Medical Writer

Artech Information System LLC; Pennington (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

A global staffing and IT consulting company is seeking a Medical Writer to coordinate and author documents for regulatory submissions. The ideal candidate should have a PhD/MD/PharmD in a relevant scientific discipline or equivalent experience in pharmaceutical regulatory documentation. Strong writing skills, organizational abilities, and experience working in cross-functional teams are essential. This role involves participating in document strategy sessions and ensuring high-quality deliverables within set timelines.

Qualifications

• PhD/MD/PharmD in scientific discipline or MS/BS with relevant experience.
• Strong writing skills for regulatory documentation and publications.
• Ability to manage timelines and quality of work in cross-functional teams.

Responsibilities

• Coordinate and author documents for regulatory submissions.
• Participate in document strategy sessions and manage timelines.
• Review and edit documents, ensuring high quality.

Skills

Strong writing skills

Organization skills

Communication skills

Interpersonal skills

Education

PhD/MD/PharmD in a relevant scientific discipline

MS / BS with a minimum of 3 to 5 years in pharmaceutical regulatory documentation

Tools

Document management system

Job description

Artech Information System , a global staffing and IT consulting company. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients and we currently have a job opening that may interest you.

Job Description

Position: Medical Writer

Duration: 6 Months

Job Description:

Scientific Writer for Aggregate Reports:

• Coordinate and author documents needed for regulatory submissions (eg, CSRs, CTD summary documents, aggregate safety reports, risk management plans), ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members.
• Participate in relevant document sub team(s) and ensure effective planning and management of timelines for all components of assigned documents.
• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
• Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
• Review and edit documents as required.
• Considerable experience in Assignment on Cross Functional Teams would be an advantage.

Qualifications:

• PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, and good understanding of requirements for regulatory submission documents. In addition, (i) demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals, (ii) good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities, (iii) demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team, (iv) working knowledge of a document management system and basic knowledge of document publishing process, (v) analyzed and interpreted complex data from a broad range of scientific disciplines.Coordinate and author regulatory documents (e.g. phase I/II clinical study reports, Investigator’s Brochure) ensuring the coordination and integration of the scientific, medical and regulatory input from development team members.2. When assigned as Lead Writer, ability to lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions.3. Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas or multiple projects.4. Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.5. Lead or co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells. 6. Able to collaborate with project team to respond to health authority questions, requests, etc.7. Provide departmental management with adequate information to help assess resource needs.

Additional Information

All your information will be kept confidential according to EEO guidelines.