Medical Writer I
55 Corporate Drive, USNJ8100 Bridgewater, NJ
The Diabetes/Cardiovascular (DCV) Manager, Global Medical Information Content serves as a member of the Global Medical Information (GMI) content team and ensures the quality and integrity of responses provided to health care professionals and patients. The position is responsible for writing and reviewing of global medical information content under the direction of the DCV Head, Global Medical Information Content. The role also includes country/region support of medical information. If needed the position will support training of support function staff and outsourced partner(s). Responsible for execution of processes and participation in cross functional projects in collaboration and alignment with GMI colleagues of other global business units (GBUs), internal and external stakeholders. This is achieved through a combination of product knowledge and intra-departmental relations, along with editing, writing, database and file management proficiency. II.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
- Serves as the Global Medical Information subject matter expert for the Therapeutic Area product(s) and maintains expertise in TA/Product scientific data, industry related information and evolution of disease area.
- Support the team’ s understanding and compliance with policies, procedures and processes
- Contributes to departmental project/task assignments; support the execution of project plans and initiatives.
- Demonstrates resolve and urgency to accomplish tasks without direct authority or control. Participate in cross functional project teams as needed. Ensure that assigned projects are completed on schedule.
- Leverages regional/local insights on content usage, to meet the need for new or updated content; look for efficiencies to optimize content creation and update.
- Provide business stakeholders with actionable insights and recommendations based on knowledge of product/therapeutic area as well as customer interactions.
- Generates BOTH Global and Local scientific responses for products in designated therapeutic area(s); as necessary, regularly reviews and maintains these documents. Contributes to local and global communications to efficiently achieve these goals.
- Responsible for engaging and collaborating with key Global cross functional stakeholders (e.g. Medical, Regulatory, etc.) to efficiently achieve these goals and to generate Global MI content assure consistent and accurate product information.
- Responsible for the localization of global content for their respective country along with supporting local medical information activities (e.g. escalation management, compendia reviews, literature summaries for annual reports, etc.).
- As the GMI subject matter expert for their respective products/therapy areas, serves as a knowledge resource for all colleagues located around the world.
- Demonstrates knowledge and understanding of pertinent Global regulatory and compliance requirements and ensures deliverable are in alignment with such requirements.
- Suggests improvements or updates to existing policies, procedures, work instructions, and work guides used in internal operations and with external vendors as needed.
- Performs on going literature reviews and extracts complex data from scientific literature and arranges the data in an organized format.
- Provides medically sound responses to complex inquiries forwarded from outsourced partner(s) and in-house sources. Proposes solutions to identified issues.
- Performs other duties as assigned.
Job Related Experience: 1-4 Years:
- Preferred - at least 1 year of direct medical information experience in the Global setting in the pharmaceutical industry, or equivalent experience & background in clinical setting.
- Medical Information fellowship/residency a plus.
KNOWLEDGE, SKILLS AND EQUIVALENT EXPERIENCE
- Knowledge and skills as a medical writer, literature evaluation, and multi-level response development.
- Excellent interpersonal, oral and written communication and presentation skills required.
- Mastery of English Language (written and spoken) Proficient in Microsoft Office Proficient in Medical Information content and inquiry management systems
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.