The Director, Medical Writing has the responsibility for the management, oversight, operations, and establishing technical direction of all medical writing activities, both internal and external, including independently researching, authoring, and editing critical and complex documents. The Director is responsible for writing, reviewing, and/or overseeing the production of clinical and regulatory documents including, but not limited to, clinical and pre-clinical clinical reports, protocols, Investigator’s Brochures, and other IND/CTA or global regulatory submission documents. The Director will be held accountable for the results of the Medical Writing group (internal and external) and will manage a team of FTE and contractor Medical Writers, as needed.
- Provides strategic input into program-level and therapeutic area plans, including input into the direction of the clinical development program and/or regulatory strategies.
- Lead and direct the medical writing activities to support clinical activities (INDs/BLAs) across the clinical programs within established timelines and approved budgets.
- Manage/produce high-quality documents in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes ensuring consistent messaging across appropriate documents (nonclinical, clinical, and product labeling)
- Review, edit, and ensure quality of documents or sections of documents prepared by other medical writers (internal or external) or functional area representatives, as required, and ensure adherence to standards.
- Contribute to manuscripts, abstracts, and poster development, as needed
- Manage in-house/contract medical writers and medical writing vendors for projects ensuring appropriate staff are available to meet program goals.
- Establish the operational standards for the medical writing activities (e.g., style guidelines, templates and QC, etc.)
- Know, understand, and ensure adherence to regulatory guidelines and department document standards
- Ensure that medical writing activities are coordinated with other departments, including Regulatory, Clinical Operations, Pharmacovigilance, and other departments.
- Recommend and implement innovative process ideas and knowledge-sharing within the company that impact time and cost efficiency.
- Contribute to relevant company Policies, SOPs, and Best Practices.
Education and Experience:
- Requires a Bachelor’s degree in science or English/Communications with significant relevant scientific experience (PhD, PharmD OR Master’s degree highly preferred) with 12+ years of relevant pharmaceutical and/or medical device industry experience,
- At least 5 years of specific medical writing experience in the pharmaceutical industry (including development of clinical study outlines, protocols, study reports, investigator brochures, and IND/BLA/NDA sections).
Knowledge and Competencies:
- Ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages constructed by the team
- Ability to interact effectively on cross-functional teams and be able to proactively facilitate effective information exchange/communication (including problem solving and issue resolution)
- Ability to lead/manage multiple projects in a fast-paced environment
- Expert-level skills with Adobe PDF, MS WORD, EXCEL, PowerPoint, and Project
- Experience with automated document templates and style guides
- Knowledge of FDA and/or EMEA regulations, GCP, ICH guidelines and familiarity working according to established GCP standard operating procedures
- Direct experience and knowledge of all the requirements needed for medical writing as related to first-in-human studies and different stage of clinical development
- Extensive leadership skills and proven ability to work within multi-disciplinary teams to influence the overall direction of projects
- Excellent communication and interpersonal skills, with the ability to effectively influence opinion and actions, and communicate strategies, plans, results and analysis, at all levels within an organization, including third parties such as CRO’s and collaborative partners.
- Ability to think strategically and to provide clear direction and expectation to other team members in a highly dynamic environment.
- Strong ability to prioritize daily work based on changing business requirements.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
May be required to travel by plane or car
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
$150k-$193k, 20% bonus, 10% 401k,stock options/RSU