Senior Strategic Medical Writer – Distant at AbbVie

Job Description

Company Description

About AbbVie

AbbVie’s mission is to find and ship revolutionary medicines and options that resolve severe well being points immediately and deal with the medical challenges of tomorrow. We attempt to have a outstanding influence on individuals’s lives throughout a number of key therapeutic areas together with immunology, oncology and neuroscience – and services and products in our Allergan Aesthetics portfolio. For extra details about AbbVie, please go to us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The S enior Strategic Medical Writer is chargeable for main and writing scientific and regulatory paperwork for drug and/or machine growth in assist of firm goals.

Responsibilities:

• Prepares scientific and regulatory paperwork wanted for the event of AbbVie medication and/or gadgets.
• Functions with a average diploma of autonomy on draft supplies however depends on overview by subject material specialists and extra senior writers for verification. Develop data and understanding of submission methods.
• Coordinates the overview, approval, and high quality management of different features concerned within the manufacturing of scientific and regulatory tasks. Arranges and conducts overview conferences with the staff.
• Produces and maintains scientific and regulatory paperwork specializing in high quality and compliance and ensures supply inside undertaking timelines. Develops understanding of undertaking administration ideas and accepts better accountability for driving submission goals.
• Develops data of US and transnational rules, necessities, and tips pertaining to the preparation of regulatory documentation. Understands and makes use of steerage related to preparation of regulatory documentation.
• Participates in execution of tactical course of enhancements.
• Identifies and proposes options to resolve points and questions arising in the course of the writing course of, together with decision or escalation as applicable.
• Works intently with management and R&D Quality Assurance to handle inquiries and draft responses, supporting an inspection-ready method.

Significant Work Activities: Continuous sitting for extended intervals (greater than 2 consecutive hours in an 8 hr day) is required

Qualifications

• A minimal of 4+ years of bio-pharmaceutical business expertise in international pharma, biotech, life science, or healthcare authority delivering medicines/ therapies to a broad market throughout varied therapeutic areas.
• Bachelor’s Degree or greater required; scientific self-discipline most popular.
• Outstanding written and oral communication abilities, with a complete data of medical and scientific terminology throughout a number of therapeutic areas.
• Proficient in assimilating and analyzing advanced knowledge.
• Experience writing and modifying scientific and regulatory paperwork following tips and rules, comparable to ICH tips, GCP, and different regulatory necessities. Familiarity with business requirements like CONSORT and PRISMA tips. EU and US machine writing expertise is a plus.
• Understanding of drug growth, scientific analysis, examine designs, biostatistics, pharmacology, regulatory necessities, and medical terminology throughout practical groups and a number of contributors
• Excellent writing abilities. Effectively communicates advanced scientific and medical info to numerous stakeholders.
• Ability to supervise a number of tasks concurrently and collaborate with cross-functional groups. Strong organizational, time administration, and problem-solving abilities.

Additional Information

​Applicable solely to candidates making use of to a place in any location with pay disclosure necessities underneath state or native legislation: ​

• The compensation vary described beneath is the vary of attainable base pay compensation that the Company believes in good religion it is going to pay for this function on the time of this posting primarily based on the job grade for this place. Individual compensation paid inside this vary will depend upon many elements together with geographic location, and we might finally pay roughly than the posted vary. This vary could also be modified within the future. ​
• We provide a complete bundle of advantages together with paid time without work (trip, holidays, sick), medical/dental/imaginative and prescient insurance coverage and 401(ok) to eligible workers.​
• This job is eligible to take part in our short-term incentive packages. ​

Note: No quantity of pay is taken into account to be wages or compensation till such quantity is earned, vested, and determinable. The quantity and availability of  any bonus, fee, incentive, advantages, or another type of compensation and advantages which might be allocable to a selected worker stays within the Company’s sole and absolute discretion except and till paid and could also be modified on the Company’s sole and absolute discretion, per relevant legislation. ​

AbbVie is an equal alternative employer and is dedicated to working with integrity, driving innovation, reworking lives and serving our neighborhood.  Equal Opportunity Employer/Veterans/Disabled.

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