Job Number: 21-11834
Job Number: 21-11834
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Medical Writer for our client in Lawrence Township, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Coordinate and author regulatory documents (e.g. phase I/II clinical study reports, Investigator's Brochure) ensuring the coordination and integration of the scientific, medical and regulatory input from development team members.
- When assigned as Lead Writer, ability to lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions.
- Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas or multiple projects.
- Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.
- Lead or co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells.
- Able to collaborate with project team to respond to health authority questions, requests, etc.
- Provide departmental management with adequate information to help assess resource needs.
- PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, and good understanding of requirements for regulatory submission documents.
- In addition, demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals,
- Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities,
- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team,
- Working knowledge of a document management system and basic knowledge of document publishing process,
- Analyzed and interpreted complex data from a broad range of scientific disciplines.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Jay Lucas | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.