Sr. Scientific Writer II

2 weeks ago

Dublin, Ireland Healthcare Businesswomen’s Association Full time

Job Description Summary

To write, edit and reconcile high quality medical and scientific communications including literature reviews, abstracts, posters and slide sets for submission to journals, congresses and/or clinical teams.

Job Description

Major accountabilities:

- Prepares literature review, abstracts, posters, and slide sets working from various data sources including clinical study reports, patient profiles etc.
- Performs quality control (QC) checking / proof reading of above documents to meet customer expectations.
- Manages assigned individual projects.
- Obtains feedback from contributors and project teams.
- Complies with and supports group’s project management tool, standards, policies and initiatives.
- Follows Novartis specifications for documentation, templates etc.
- Maintains records for all assigned projects including archiving.
- Maintains audit, SOP and training compliance.
- Performs additional tasks as assigned.

Key performance indicators:

- Preparation of the above referenced documents meeting set quality standards and on time for submission to Health Authorities/ Clinical teams / Journals as appropriate (i.e. complying with standards e.g. CONSORT regarding publication of trial results, complying with journal formatting requirements etc).
- Publications are acceptable to internal and external authors (no issues with authorship).
- Completion of an adequate number of medical and scientific documents (taking into account complexity) per year.
- Adhere to Novartis values and behaviours.

Minimum Requirements:

Education and Work Experience:

- Minimum: Life-science degree or equivalent.
B.Sc./equivalent with 4 years Clinical Research (CR) experience, M.Sc./M.Pharm + 2 years of CR experience.
- Desired: Doctoral degree, Qualification in Medical Sciences (MBBS/MD/equivalent). PhD + 1 year of CR experience, MBBS/equivalent + 1 year of CR experience.

Skills:

Functional competencies (Fundamental):

- Results Driven; Customer/Quality Focus; Leadership; Innovative and creative; Action oriented; Show initiative; Empowerment / Accountability; Commitment / Self discipline; Mutual respect / Trust / Loyalty / Candor; Open Communication / Collaboration/Compassion; Drug Development knowledge; Science and Technology; Commercial Proficiency; Operational Excellence; Clinical communication & Info. Mgmt.

Leadership Competencies (Fundamental):

- Sets clear direction and aligns team and others around common objectives.
- Energizes the team.
- Displays passion for the 3 Cs (Consumers, Customers, Competition).
- Exercises good judgment and drives change for competitive advantage.
- Drives for superior results and has passion to win.
- Displays analytical and conceptual thinking.

Functional Experience:

- Scientific/ clinical knowledge of safety aspects, TA, disease, brand (Solid, Critical).
- Writing medical documents and publications (e.g., abstracts, literature review, slide sets, posters, manuscripts, meeting reports) (Exposure, Critical).
- Clinical Research/ Drug Development (Exposure, Critical).
- Drug Safety (Exposure, Critical).
- Quality management (Exposure, Critical).
- IT/ web applications, office productivity tools and document formatting skills (Exposure, Critical).

Leadership Experience:

- Project Management (Exposure, Critical).
- Third Party (Customer/Vendor/Buyer) Relationship Management Exposure (Desired).
- Driving operational excellence Exposure (Critical).

Languages:

- Excellent written and oral English skills

Skills Desired: Clinical Research, Clinical Trials, Detail-Oriented, Medical Writing, Safety

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