Principal Strategic Medical Writer (Remote)

Allergan; Greenlawn (NY); Remote; USD 100,000 - 150,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Principal Strategic Medical Writer to join their Specialty therapeutic area team in Greenlawn, NY. The role involves creating high-quality clinical and regulatory documents and guiding teams on strategic medical writing processes. Candidates should possess strong communication skills and a scientific background, with at least 5 years of relevant experience.

Benefits

Paid time off

Medical/dental/vision insurance

401(k) plan

Short-term incentive programs

Long-term incentive programs

Qualifications

• Minimum of 5+ years of bio-pharmaceutical industry experience.
• Extensive experience writing clinical documents.
• Ability to oversee multiple projects simultaneously.

Responsibilities

• Lead and write clinical and regulatory documents.
• Coordinate review and quality control of documents.
• Communicate deliverables and timelines to team members.

Skills

Communication skills

Writing skills

Problem-solving skills

Organizational skills

Analytical skills

Education

Bachelor's Degree or higher in a scientific discipline

Tools

ICH guidelines

GCP

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

AbbVie's Strategic Medical Writing team within the Specialty therapeutic area is dedicated to creating high-quality, evidence-based documents that support the development and communication of innovative therapies. We are recognized as leaders in medical writing, driving success through strategic insights and scientific excellence. We foster a collaborative environment which enables us to transform complex scientific data into clear, impactful narratives fulfilling AbbVie’s mission to deliver innovative medicines and solutions that address multifaceted health issues and enhance people's lives.

As a Principal Strategic Medical Writerat AbbVie, you will be responsible for leading and writing clinical and regulatory documents in support of company objectives.

Your role responsibilities:

• Independently writemost clinical and regulatory documents within remit. Coordinatethe review, approval, and quality control of other functions involved in the production of clinical and regulatory documents. Arrangeand conducts review meetings with the team. Workclosely with the team(s) on document authoring and content strategies.
• Communicatedeliverables needed, writing process, and timelines to team members.
• Holdteam members accountable to agreed-upon project dates.
• Contributeto project management strategies and develops ability to lead team members, driving submission objectives.
• Recommend, leads, and/or participatein implementation/execution of tactical process improvements.
• Developexpert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation.
• Identify and propose solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
• Learnand applytherapeutic area and product knowledge to scientific projects and business improvement projects.
• Workindependently with R&D Quality Assurance to address inquiries and draft responses, maintaining an inspection-ready approach.

Qualifications

As a qualified candidate, you hold a Bachelor's Degree or higher in a scientific discipline andhave a minimum of 5+ years of bio-pharmaceutical industry experience in a global pharma, biotech, life science, federal agency organization delivering medicines/therapies to a broad market across various therapeutic areas.

You also demonstrate the following knowledge and skills:

• Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas.
• Excellent writing skills, effectively communicate and influence complex scientific and medical information to various stakeholders.
• Extensive experience writing, editing clinical documents following guidelines and regulations, such as ICH guidelines, GCP, and other regulatory requirements. Familiarity with industry standards like CONSORT and PRISMA guidelines.
• Proficient in assimilating and analyzing complex data
• Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology across functional teams and multiple contributors
• Ability to oversee multiple projects simultaneously and collaborate with cross-functional teams. Strong organizational, time management, and problem-solving skills.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html