Job Description
The Position
Lead medical writing of clinical regulatory documents for various types of regulatory filings, including but not limited to : Protocol, Protocol Amendments & CSRs for inline trials, Agency Background Packages and Response to Agency Inquiry, 2.
5 Clinical Overviews, Clinical and Non-Clinical summaries and Module 5 documents. Other responsibilities would also include maintenance of common templates and provide content management support (i.
e., formatting, citations, content authoring tool workflow facilitation). This position will be required to coordinate routinely with leadership in the Product Registration (Regulatory Liaison) organization, Medical / Clinical / Safety organizations (with CRO), vendor oversight and IT.
Responsibilities
Interact with therapeutic / functional area leaders to execute on organizational priorities.
Ensures timely and high-quality completion of Medical Writing deliverables that include the proper content and context and clear and consistent medical / scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
Drive interaction and clear handoffs between stakeholder SME organizations (Clinical, Safety, Regulatory, Non-Clinical) to the RMW team.
Support and drive partnering with vendors to provide Medical Writing support.
Lead the development, alignment, and consistent implementation of processes.
Ensures appropriate systems in place such that quality assurance review of documents occurs.
Drive the preparation / revision of document templates, development of process, and preparation / revision of SOPs and guidance documents.
Develops and drives process supporting content authoring and formatting to a standard within the global content authoring platform.
Participates in Clinical Research Organization (CRO) alliance and other outsourcing activities.
Provides strategic direction and oversight of multiple contractor (partner) RMW’s composed of senior / experienced RMW and junior RMW roles.
Required Education, Experience and Skills
Master’s degree in Life Sciences / PhD / PharmD preferred.
Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
Understanding of FDA / international regulations, ICH guidelines, and applicable US / international regulatory processes related to document preparation and production (including CTDs).
Must have proven track record to be able to think critically, strategically, independently and problem solve.
Must have high level of motivation, drive, and demonstration of our new company's leadership values.
Excellent time and project management skills.
Excellent written and verbal communication skills including ability to write clearly and concisely.
Top notch interpersonal skills in difficult situations.
Ability to collaborate across multiple functional areas.
Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.
At least 12 years of regulatory medical writing experience is required.
Experience as lead writer for key documents included in major US / EU and / or international regulatory submissions required.
At least 12 years of regulatory medical writing experience is required.
Experience as lead writer for key documents included in major US / EU and / or international regulatory submissions required.
Who We Are :
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for.
We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.
Our Vision is clear : A better and healthier every day for every woman.
US and PR Residents Only
For more information about personal rights under Equal Employment Opportunity, visit :
Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.
Applicable to United States Positions Only : Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job.
Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and / or prior work experience.
The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver / parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
Annualized Salary Range (US)
$150,600.00 - $256,300.00
Please Note : Pay Ranges are Specific to local market and therefore vary from country to country
Employee Status : Regular
Regular
Relocation : No relocation
No relocation
VISA Sponsorship :
Travel Requirements : Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
No Travel Required
Flexible Work Arrangements :
Remote Work
Shift : Not Indicated
Not Indicated
Valid Driving License :
Hazardous Material(s) :
Number of Openings :
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